Uncontrolled T2D Research Articles

746-P: Semaglutide Increases the Proportion of People with T2D Achieving a Metabolic Composite Endpoint

Hyperglycemia, high BP and dyslipidemia are common risk factors for CVD. The aim of this study was to assess the proportion of participants treated with once-weekly (OW) semaglutide, or a comparator, achieving a metabolic composite target endpoint in the SUSTAIN trials. Participants from SUSTAIN 1-5, 7-10 and SUSTAIN China with uncontrolled T2D treated with OW semaglutide vs comparators (incl. placebo) were pooled, and the proportion achieving the endpoint (HbA1c <7%, BP <140/90 mmHg and non-HDL cholesterol <130 mg/dL) was assessed. Endpoints were analyzed using on treatment without rescue medication data for each trial, using a binomial logistic regression model with treatment, region/country, and stratification factor as fixed effects and baseline value (HbA1c/BP/Non-HDL) as covariate. Pooled analysis was conducted using logistic regression with treatment and trial as fixed effects and baseline value as covariate. Treatment with 0.5 and 1 mg OW semaglutide was associated with higher odds (OR range 1.4-24.4) of achieving the endpoint vs comparators (Figure). The proportion of participants reaching the composite endpoint across all trials was 24% and 32% for 0.5 mg and 1.0 mg semaglutide, respectively, vs 11% for comparators (p<0.0001). The results indicate that OW semaglutide may assist with the co-management of T2D and cardiometabolic risk factors, which could reduce the risk of CVD in people with T2D. Disclosure L.Ji: Other Relationship; Eli Lilly and Company, Novo Nordisk, Merck & Co., Inc., Bayer Inc., Sanofi-Aventis U.S., Roche Pharmaceuticals, MSD Life Science Foundation, AstraZeneca, Boehringer Ingelheim Inc., Abbott, Metronics. C.H.Sorli: Employee; Acerus Pharmaceuticals. A.Ahmann: Advisory Panel; Medtronic. B.Ahrén: Speaker's Bureau; Novo Nordisk, Nestlé Health Science, Stock/Shareholder; Novo Nordisk, AstraZeneca, Eli Lilly and Company. M.Capehorn: Advisory Panel; Novo Nordisk, Lilly Diabetes, Boehringer Ingelheim Pharmaceuticals Inc., Research Support; Boehringer Ingelheim Inc., Novo Nordisk, Lilly, Speaker's Bureau; Novo Nordisk, Lilly, Boehringer Ingelheim Inc. P.Hu: Employee; Novo Nordisk (China). I.Lingvay: Advisory Panel; Novo Nordisk A/S, Lilly Diabetes, Boehringer-Ingelheim, Sanofi, Consultant; Carmot Therapeutics, Inc., Merck Sharp & Dohme Corp., Janssen Scientific Affairs, LLC, Pfizer Inc., Intercept, Intarcia, Valeritas, TargetRWE, Shionogi, Zealand Pharma, Structure, Bayer, Research Support; Novo Nordisk A/S, Boehringer-Ingelheim. W.Liu: Employee; Novo Nordisk (China). H.W.Rodbard: Advisory Panel; Merck Sharp & Dohme Corp., Pacira BioSciences, Inc., Research Support; Eli Lilly and Company, Medtronic, Sanofi, Novo Nordisk. Z.Shen: Employee; Novo Nordisk (China).

Patient-centered medical home pharmacists’ impact on composite quality care measures for patients with uncontrolled type 2 diabetes

BackgroundPatients with uncontrolled diabetes are at risk for developing complications. Many health care systems have implemented multidisciplinary care models including pharmacists to help achieve quality care measures to reduce complications. ObjectiveThis study aimed to evaluate whether patients with uncontrolled type 2 diabetes mellitus (T2D) seen at patient-centered medical home (PCMH) clinics affiliated with an academic medical center are more likely to meet a composite of diabetes quality care measures with a pharmacist on their care team than usual care patients without a pharmacist on their care team. MethodsThis is a cross-sectional study. The setting included PCMH primary care clinics affiliated with an academic medical center from January 2017 to December 2020. Included were adults aged 18 to 75 years with a diagnosis of T2D, hemoglobin A1C (A1C) more than 9%, and established with a PCMH provider. The intervention is inclusion of PCMH pharmacist on the patient’s care team for management of T2D per a collaborative practice agreement. The main outcome measures included A1C ≤9% per last recorded value during observation period, a composite A1C ≤9% and completion of yearly laboratory tests, and a composite A1C ≤9%, completion of yearly laboratory tests, and statin prescription for adults aged 40-75 years. ResultsIdentified were 1807 patients in the usual care cohort with mean baseline A1C of 10.7% and 207 patients in the pharmacist cohort with mean baseline A1C of 11.1%. The pharmacist cohort was more likely to have an A1C of ≤9% at the end of the observation period (70.1% vs. 45.4%; P < 0.001), a composite of measures met (28.5% vs. 16.8%; P < 0.001), and a composite of measures met for patients aged 40-75 years (27.2% vs. 13.7%; P < 0.001). ConclusionPharmacist involvement in the multidisciplinary management of uncontrolled T2D is associated with a higher attainment of a composite of quality care measures at the population health level.

TG/HDL, Non-HDL, and TyG index as predictive parameters for CVDs in uncontrolled diabetic patients better than LDL-C and LDL/HDL ratio

Type 2 diabetes is widely associated with dyslipidaemia in uncontrolled patients. Prediction parameters of cardiovascular diseases have controversial issue. Therefore, the aims of this study were to investigate i) the possibility of prediction of cardiovascular diseases (CVDs) from lipoprotein ratios (TG/HDL ratio, TC/HDL ratio) and/or non-HDL level ii) the role of TyG index in prediction of CVDs in uncontrolled DM. 107 participants were recruited in this study, 34 participants were DM (32%; control) and 73 participants were uncontrolled DM (68%). HbA1c, Fasting plasma glucose, lipid profile were measured. In this study the mean age of control DM group was (50.2±2.2), and (54.1±1.6) for uncontrolled group. Weight was higher in uncontrolled DM group. FPG and HbA1c were higher in uncontrolled group. Neither LDL-C nor LDL/HDL ratio showed a significant difference between controlled DM and Uncontrolled DM. TG/HDL was elevated in uncontrolled DM. non-HDL and TyG index were significantly increased in the uncontrolled group. We concluded that neither LDL-C nor LDL/HDL ratio have a predictive role for CVDs as proposed previously. TG/HDL ratio, non-HDL, and TyG index pointed out as a useful predictive parameters for CVDs in uncontrolled T2D.

LBSUN210 Efficacy And Safety Profile Of Insulin Icodec Versus Insulin Glargine U100 In Type 2 Diabetes Mellitus: A Meta-Analysis Of Randomized Controlled Trials

Abstract In the context of diabetes, clinical inertia is defined as the failure to initiate insulin therapy or its intensification when treatment goals have not been met. Patient-related factors that contribute to this phenomenon include inability to follow complex regimens, cost of treatment and drug side effects. Icodec is a novel, investigational, ultra-long acting, once-weekly insulin analog with a potential for better treatment adherence. However, early evidence from phase 2 trials on icodec in type 2 diabetes mellitus (T2D) is conflicting. To study the efficacy and safety of insulin icodec, we conducted a meta-analysis of published randomized controlled trials (RCTs) on weekly icodec vs. daily glargine U100 in patients with uncontrolled T2D (HbA1c &amp;gt; 7%). A systematic search in major online databases was done to identify and review relevant RCTs. Two authors independently performed the study selection and extracted study data. Data on glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), time-in-range of 70-180 mg/dL (TIR), adverse events and hypoglycemia events were noted. Significance level of 95% was used to provide pooled estimates. Random effects model was used for analysis with significant heterogeneity (I2&amp;gt;50%). Three trials with 606 patients were included. Pooled analysis of available data showed that icodec resulted in a significantly greater mean reduction of HbA1c (mean difference (MD)=0.18%[0.13,0.22], p&amp;lt;0. 00001, I2=84% in 2 studies), mean reduction of FPG (MD=3.87mg/dl [3.18, 4.57],p&amp;lt;0. 00001, I2=0%), longer TIR (MD=4.39% [3.94, 4.85], p&amp;lt;0. 00001, I2=0%), but had significantly greater propensity to lead to level 1 hypoglycemia (Odds Ratio (OR)=1.59 [1.11,2.28], p=0. 01, I2=29%) when compared to glargine U100. Funnel plot analysis on the propensity for icodec to lead to any hypoglycemia event decreased the I2 statistic from 78% to 0% and showed significantly greater hypoglycemia events with icodec (OR=2.59 [1.67,4. 01], p&amp;lt;0. 001). There was no significant difference in the number of patients with end-of-trial HbA1c &amp;lt;7%, and any adverse event, or hypoglycemia level 2 or 3. Of note, only one hypoglycemia level 3 event was noted (patient on icodec). Once-weekly icodec had significantly better glycemic control compared to daily glargine U100, but had significantly greater hypoglycemia events. Data from ongoing trials on this novel drug can be added to the analysis as they become available. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.

Role of therapeutic inertia in glycemic control according to individualized objectives in a cohort of patients with type 2 diabetes. Results from CONCARDIA2

Background and objectiveTherapeutic inertia (TI) is the lack of initiation or intensification of treatment when indicated. It contributes to the fact that more than a third of people with type 2 diabetes mellitus (T2D) do not have adequate metabolic control. We set out to analyze the impact of TI during 4 years of follow-up in a cohort of T2D and its possible variables. Materials and methodsProspective cohort study of a cohort of 297 TD2 patients. We considered TI when treatment was not modified during the 4 years, despite poor control. We contemplate uncontrolled those that did not meet their individualized HbA1c target. ResultsUncontrolled patients: 87; age: 62.2 ± 9.2; 58.7% men. We consider TI in 41.6% of the patients. Average HbA1c 8.22% in patients with treatment intensification of which 43.1% achieved their HbA1c goal, 29.8% were on monotherapy at the beginning, 29.8% double, 36.2% triple and 2,1% in quadruple therapy. There was more change in treatment in people with obesity (67.6 vs. 34.6%; P < 0.01) and the 6 of the study patients with cardiovascular events (P < 0.05). Metformin was part of the treatment in 97.1% of IT cases (vs. 76.6%; P < 0.01). Achievement of the HbA1c target was higher in patients receiving iSGLT2 (0 vs. 68.4%; P < 0.001). ConclusionsIn 2 out of 5 uncontrolled T2D patients, the treatment was not changed; this was more evident in those patients treated with metformin. Patients with obesity and presence of cardiovascular events seem to protect against IT. Those who were on iSGLT2 have an advantage in meeting their HbA1c target.

Type 2 Diabetes Independent of Glycemic Control is Associated With Cognitive Impairments: Findings From NHANES.

Examine the association between glycemic control and cognition. Included subjects ≥60 years who participated in the 2013 to 2014 National Health and Nutrition Examination Survey and completed one of the followings: Consortium to Establish a Registry for Alzheimer's Disease Word List (CERAD-WL), Animal Fluency (AF), Digit Symbol Substitution Test (DSST), and CERAD-Delayed Recall (CERAD-DR). Stratified participants into: No type 2 diabetes (T2D; N = 557), Controlled T2D (N = 41), Uncontrolled T2D (N = 120), and Untreated T2D (N = 86). Multiple regression was used to examine the association between variables. After adjusting for demographics and cardiovascular risk factors, Uncontrolled T2D was associated with lower DSST (β = -3.164, p = .04), and Untreated T2D was associated with a trend for having lower CERAD-DR (β = -.496, p = .06) scores. T2D, independent of glycemic control, is associated with cognitive impairment and this relationship is influenced by modifiable and non-modifiable risk factors.

Abstract 34: Time spent in glycemic control after initiating treatment with oral semaglutide versus empagliflozin: An exploratory analysis of the PIONEER 2 trial

A standard objective in the management of T2D is the achievement and maintenance of HbA1C targets, but the duration of time that patients spend within glycemic control targets has not been previously reported for oral semaglutide (sema). In this exploratory analysis, the duration of time that patients were in glycemic control (HbA1C <7.0% and <6.5%) during the 52-week PIONEER 2 trial (NCT02863328) was assessed. Patients with uncontrolled T2D (N=822; HbA1C 7.0─10.5%) were randomized to oral sema 14 mg once daily or empagliflozin (empa) 25 mg once daily. Both drugs underwent dose escalation, with oral sema starting at 3 mg, increasing to 7 mg after 4 weeks, and 14 mg after 8 weeks. Empa was initiated at 10 mg and escalated to 25 mg after 8 weeks. For this analysis, outcomes were evaluated using the on-treatment without rescue medication observation period, in all randomized patients. Baseline characteristics were similar between treatment arms. Mean baseline HbA1C for both arms was 8.1%. A greater proportion of patients receiving oral sema vs. empa achieved HbA1C <7.0% at some point during the study (78% vs. 60%), and for the following lengths of time that HbA1C remained <7%: ≥14 weeks (65% vs. 48%); ≥26 weeks (56% vs. 38%); and ≥38 weeks (46% vs. 28%). During treatment, the overall mean duration of time spent at HbA1C <7.0% and <6.5% was 27 weeks and 16 weeks, respectively, for oral sema, and 19 weeks and 7 weeks for empa. Based on the trial product estimand, the odds of patients achieving HbA1C <7.0% at both week 26 and 52 were significantly greater with oral sema vs. empa (estimated odds ratio 4.12 [95% CI 2.94, 5.76]; p<0.0001). In conclusion, despite an 8-week dose escalation schedule and a mean baseline HbA1C of 8.1%, nearly half of patients receiving oral sema achieved glycemic control (HbA1C <7.0%) for more than 70% of the 52-week treatment duration. These data suggest that patients spend more time in glycemic control during treatment with oral sema vs. empa.

Comparison of Therapies with GLP1 Analogues in Type 2 Diabetic Patients Without Control

BackgroundType 2 Diabetes (T2D) is a chronic disease in the aspect of insulin resistance in the adulthood, that requires continuous medical attention and represents a therapeutic challenge beyond glycemic control. Glucagon-like Peptide-1 receptor analogues (GLP-1) have a favorable effect in modifying cardiovascular risk factors. the objective is to analyze the clinical benefits of there. MethodsComparison of three descriptive, retrospective cohort studies, conducted between June-2013 and June-2016, 52 week follow-up, including patients with uncontrolled T2D, with different therapies, who were added to the treatment GLP-1 analogues, in a high complexity center in the city Cali, Colombia. Three specific therapies where compared: Liraglutide 1.8 mg/day; exenatide 2 mg/week, and exenatide 2 mg/week plus dapagliflozin/metformina 10/2000 mg/day, respectively. Repeated measurements were made over time of glycated hemoglobin (A1C), weight, and blood pressure (BP). ResultsThe mean age was 60.6 years. The onset of T2D was 6.2 years. Combination therapy showed an average decrease of: A1C of 1.8% for Liraglutide (IC 95%, 1.52-2.04; P<0.0001), 1.7% for exenatide (IC 95%, 1.45-1.94, p<0.000) and 0.70% for exenatide plus dapagliflozin/metformin (CI 0.58 to 0.82, p <0.001); weight loss of: 5.1 kg, 5.8 kg and 3.04 kg respectively; and decrease of systolic BP of: 6.7mmHg, 15.6 mmHg and 16.3 mmHg, respectively. The largest decrease in A1C occurred between first and second visit and no serious adverse events were observed. ConclusionGLP-1 analogues are a favorable therapeutic option for patients with uncontrolled T2D, with beneficial effect on body weight and BP with statistically significant results.

670-P: Time Spent in Glycemic Control after Initiating Treatment with Oral Semaglutide vs. Empagliflozin: An Exploratory Analysis of the PIONEER 2 Trial

A standard objective in the management of T2D is the achievement and maintenance of HbA1c targets, but the duration of time that patients spend within glycemic control targets has not been previously reported for oral semaglutide (sema). In this exploratory analysis, the duration of time that patients were in glycemic control (HbA1c &amp;lt;7.0% and &amp;lt;6.5%) during the 52-week PIONEER 2 trial (NCT02863328) was assessed. Patients with uncontrolled T2D (N=822; HbA1c 7.0─10.5%) were randomized to oral sema 14 mg once daily or empagliflozin (empa) 25 mg once daily. Both drugs underwent dose escalation, with oral sema starting at 3 mg, increasing to 7 mg after 4 weeks, and 14 mg after 8 weeks. Empa was initiated at 10 mg and escalated to 25 mg after 8 weeks. For this analysis, outcomes were evaluated using the on-treatment without rescue medication observation period, in all randomized patients. Baseline characteristics were similar between treatment arms. Mean baseline HbA1c for both arms was 8.1%. A greater proportion of patients receiving oral sema vs. empa achieved HbA1c &amp;lt;7.0% at some point during the study (78% vs. 60%), and for the following lengths of time that HbA1c remained &amp;lt;7%: ≥14 weeks (65% vs. 48%); ≥26 weeks (56% vs. 38%); and ≥38 weeks (46% vs. 28%). During treatment, the overall mean duration of time spent at HbA1c &amp;lt;7.0% and &amp;lt;6.5% was 27 weeks and 16 weeks, respectively, for oral sema, and 19 weeks and 7 weeks for empa. Based on the trial product estimand, the odds of patients achieving HbA1c &amp;lt;7.0% at both week 26 and 52 were significantly greater with oral sema vs. empa (estimated odds ratio 4.12 [95% CI 2.94, 5.76]; p&amp;lt;0.0001). In conclusion, despite an 8-week dose escalation schedule and a mean baseline HbA1c of 8.1%, nearly half of patients receiving oral sema achieved glycemic control (HbA1c &amp;lt;7.0%) for more than 70% of the 52-week treatment duration. These data suggest that patients spend more time in glycemic control during treatment with oral sema vs. empa. Disclosure J. Rosenstock: Board Member; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Consultant; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Inc., Novo Nordisk, Oramed Pharmaceuticals, Inc., Sanofi, Research Support; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Genentech, Inc., Intarcia Therapeutics, Inc., Lexicon Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Oramed Pharmaceuticals, Inc., Pfizer Inc., REMD Biotherapeutics, Sanofi. B. Cariou: Board Member; Self; Bristol-Myers Squibb Company, Gilead Sciences, Inc., Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk, Sanofi, Research Support; Self; Amgen Inc., AstraZeneca, Regeneron Pharmaceuticals Inc., Speaker’s Bureau; Self; Abbott Diabetes, Akcea Therapeutics. E. Christiansen: None. C. L. Hertz: Advisory Panel; Spouse/Partner; SNIPR BIOME APS, Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S. E. Montanya: Advisory Panel; Self; Sanofi, Consultant; Self; Merck Sharp &amp; Dohme Corp., Employee; Spouse/Partner; Almirall, S. A., Research Support; Self; Menarini Group, Roche Diagnostics SL, Speaker’s Bureau; Self; Novo Nordisk A/S. M. Abildlund nielsen: Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Lundbeck, Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. F. K. Knop: Advisory Panel; Self; MSD Corporation, Novo Nordisk A/S, Sanofi, Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk A/S, Pharmacosmos, Zealand Pharma A/S, Research Support; Self; Novo Nordisk A/S, Zealand Pharma A/S, Speaker’s Bureau; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MSD Corporation, Novo Nordisk A/S. Funding Novo Nordisk A/S

965-P: Real-World Evidence of the Effect on Glycemic Control with Relatively Simultaneous vs. Sequential Initiation of Basal Insulin and GLP-1 Receptor Agonists

Injectable therapy initiation in T2D is often delayed. This retrospective cohort study evaluated the impact of the timing of initiating both basal insulin and GLP-1 RA in people with uncontrolled T2D (HbA1c ≥9 %) on OADs within 12 months (Optum Humedica database of electronic medical records and claims; 1/1/2011 to 6/30/2017). Study cohorts were defined by the days between initiating the first and second injectable: cohort A ≤30 (simultaneous); B 31-90; C 91-180; D 181-270; E 271-360 (sequential). Endpoints: proportion achieving HbA1c &amp;lt;7 % or &amp;lt;8 % and achieving ≥1 % or ≥2 % reduction in HbA1c at 6 and 12 months after initiating the second injectable. Baseline characteristics (N=6339): mean ± SD age 54 ± 11 years; HbA1c 10.7 ± 1.5 %; weight 108 ± 25 kg; 47% male. Despite slightly higher baseline HbA1c, cohort A had the best glycemic outcomes at 6 and 12 months for all 4 endpoints, followed by cohort B, then no difference between C, D and E (Table). Cohorts C, D and E were significantly less likely to achieve HbA1c &amp;lt;7 % than cohort A (hazard ratios [95% CI]: 0.62 [0.53-0.72]; 0.62 [0.53-0.72]; 0.63 [0.54-0.73]), but cohort B was not (0.87 [0.76-1.01]). In summary, despite higher baseline HbA1c, addition of a second injectable agent within 90 days of the first led to significantly better glycemic control at 12 months than postponing addition to later in the year in uncontrolled T2D. Disclosure J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc., REMD Biotherapeutics. Other Relationship; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. F. Ampudia Blasco: None. R. Lubwama: Employee; Self; Sanofi US. X.V. Peng: Employee; Self; Sanofi. A.H. Boss: Employee; Self; Sanofi. Stock/Shareholder; Self; Novo Nordisk Inc., Sanofi. L. Shi: None. V. Fonseca: Consultant; Self; Abbott, Asahi Kasei Corporation, AstraZeneca, Bayer Inc., Novo Nordisk Inc., Sanofi. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Stock/Shareholder; Self; Amgen, Bravo4health. Funding Sanofi

947-P: Semaglutide Added to Treatment or Changed from Other GLP-1 Receptor Agonist in Type 2 Diabetes: A Study to Evaluate Real-World Effectiveness

Objective: To evaluate real-world clinical outcomes of semaglutide on glycemic control and weight as an add-on to treatment or changed-on from other GLP-1 in patients with T2D who initiate treatment. Patients and Methods: To better understand the effectiveness of semaglutide on clinical outcomes in a real-world setting, this retrospective cohort study included eligible patients were at least 18 years old with uncontrolled T2D (HbA1c 6.5-11%) receiving stable therapy that initiated subcutaneous semaglutide 0.5 or 1.0 mg once weekly added to their therapy or after a change from other GLP-1. Primary endpoint was change from baseline in glycated Hb (HbA1c) and confirmatory secondary endpoint was change from baseline in body weight, both at week 24. Semaglutide was initiated as part of their diabetes therapy based in clinical practice. Results: in this study, were included 147 patients had a mean age of 60.3 ± 10.1 years, T2D duration of 14.0 ± 7.4 years, and baseline A1C of 8.3 ± 1.34%. Seventy-five were naïve in treatment with GLP-1 and seventy-four received previously another GLP-1 (liraglutide 1.8 mg daily or dulaglutide 1.5 mg once weekly). At 6 months follow-up, 145 patients who remained on-treatment showed an A1C reduction of 1.2 ± 1.15% (p&amp;lt;0.05), A1C lowering was seen in both groups: a reduction de 1.8±1.8% (p &amp;lt; 0.05) in patients that received GLP for first time and 0.6± 1.0%(p&amp;lt; 0.05) in group prior use of GLP-1. Mean weight reduction was 5.1 ± 4.6 kg (p &amp;lt; 0.001) in the group initiated GLP-1 for first time and 2.1±4.0 kg (p&amp;lt;0.01) in group that changed from another GLP-1. Four patients presented gastrointestinal adverse events to retire the treatment, all of them in the group that never had been treated with GLP-1. Conclusion: In this real-world study, patients initiating semaglutide had significant reductions in HbA1c and weight. The effect was reached whether patients received GLP-1 for the first time or if a change had been made from another GLP-1. Disclosure J. Ferrer-García: None. R. Albalat Galera: None. L. Arribas: None. M. Tolosa Torrens: None. A. Sánchez Lorente: None. A.J. Portilla: None. A. Artero: None. C. Sánchez-Juan: None.

The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial.

Insulin degludec/liraglutide (IDegLira) results in glycated hemoglobin (HbA1c) levels comparable with basal-bolus (BB) therapy. Here, we assessed the effect of once-daily IDegLira compared with BB (once-daily insulin glargine 100 U/mL and insulin aspart ≤4 times/day) across subgroups with varying characteristics. DUAL VII trial participants (type 2 diabetes [T2D], HbA1c 53-86 mmol/mol [7.0%-10.0%]) were subgrouped post hoc based on the following baseline characteristics: HbA1c (≤58.5, >58.5 to ≤69.4, and >69.4 mmol/mol; ≤7.5%, >7.5 to ≤8.5%, and >8.5%), body mass index (<30, ≥30 to <35, and ≥35 kg/m2), age (18 to <65 and ≥65 years), duration of diabetes (≥0 to 10 and ≥10 years), total pretrial daily basal insulin dose (20 to <30, ≥30 to <40, and ≥40 to ≤50 U), and fasting plasma glucose (<7.2 mmol/L/<130 mg/dL and ≥7.2 mmol/L/≥130 mg/dL). Compared with BB, and in all subgroups, IDegLira treatment consistently gave similar HbA1c reductions, less severe or blood glucose-confirmed hypoglycemia, lower end-of-trial (EOT) total daily insulin dose, and weight loss. In all subgroups, mean EOT HbA1c was ≤53 mmol/mol (≤7.0%). The greatest HbA1c reduction occurred in the highest baseline HbA1c subgroup. Overall, mean EOT daily insulin dose was 0.43 to 0.52 U/kg with IDegLira and 0.74 to 1.07 U/kg with BB. More participants achieved the triple composite endpoint (HbA1c <53 mmol/mol [<7.0%] without weight gain or hypoglycemia) with IDegLira vs BB across the baseline HbA1c subgroups (≤58.5 mmol/mol [44.6% vs 7.0%], >58.5 to ≤69.4 mmol/mol [41.1% vs 8.3%], and >69.4 mmol/mol [23.8% vs 3.4%]). These results support initiating IDegLira in patients with varying baseline characteristics and uncontrolled T2D on basal insulin. NCT02420262.

761-P: Correlation of Periodontal Inflamed Surface Area with Glycemic Status in Patients with Controlled Type 2 Diabetes Mellitus and Uncontrolled Type 2 DM With and Without Microvascular Complications

The bidirectional relationship between periodontitis and diabetes mellitus has been well documented. Periodontitis causes systemic inflammatory burden through inflammatory mediators. The currently used tools such as Clinical Attachment Loss (CAL) and Probing Pocket Depth (PPD) to assess periodontitis are linear measurements, that do not exactly quantify the inflammatory burden of periodontitis. Periodontal Inflamed Surface Area (PISA) reflects the surface area of bleeding pocket epithelium and estimate the inflammatory burden. This study was undertaken to assess the proportion of periodontitis and correlation of PISA with glycemic status in controlled, uncontrolled type 2 diabetes mellitus (T2D) with and without micro-vascular complications. The study comprised of 180 T2D patients who were divided into three groups based on their Glycosylated Hb levels (HbA1c) (i) well controlled T2D group: (HbA1c ≤ 7%) (ii) Uncontrolled T2D group: (HbA1c &amp;gt; 7%) without complications, and (iii) Uncontrolled T2D group: (HbA1c &amp;gt;7%) with microvascular complications. All subjects were assessed for the periodontal parameters (Bleeding on Probing (BOP), PPD, CAL and PISA) and systemic parameters (HbA1c, FPG, and PPPG). The proportion of periodontitis among Uncontrolled T2D group without complication and Uncontrolled T2D group with micro-vascular complications was (93.4% and 96.6%) very high as compared to Well controlled T2D group (75%) (p &amp;lt;0.001). Extent and severity of periodontitis were high in uncontrolled T2D group. Uncontrolled T2D with micro-vascular complications group attained the highest mean score for PPD, CAL, BOP and PISA. Positive correlation was found between PISA and HbA1c among the groups (r = 0.079, 0.109, 0.248 respectively). A statistically significant positive correlation has been found between PISA and HbA1c among all study subjects (r= 0.393, p &amp;lt; 0.001). Disclosure C. Radhakrishnan: None. R.J. Vadakkekuttical: None. K. Anil: None. F.C. Parambath: None.

1096-P: Determining the Optimal Fasting Glucose Target for Patients with Type 2 Diabetes: Results of the FPG Goal Trial

Background: The optimal fasting glucose target to achieve an HbA1c &amp;lt;7.0% in patients with T2D remains controversial. Methods: This open-label RCT conducted in China (ClinicalTrials.gov, NCT02545842), randomly assigned (1:3:3) adults (aged 18-65 years) with uncontrolled T2D (HbA1c &amp;gt;7% to ≤10.5%) on 1-3 OADs to 1 of 3 self-monitored fasting blood glucose (FBG) target groups: ≤5.6 mmol/L (Group 1), ≤6.1 mmol/L (Group 2), or ≤7.0 mmol/L (Group 3). The lowest of 3 consecutive FBG values was used for insulin glargine 100 U/ml titration decisions. Primary endpoint was the proportion of patients achieving an HbA1c &amp;lt;7.0% at 24 weeks. Results: Of 947 patients randomized (Group 1, n=136; Group 2, n=405; Group 3, n=406), 914 were analyzed (mean age 53.9 years; 56.2% male; mean HbA1c 8.59%), and 885 (93.4%) completed the study. At 24 weeks, 44.4%, 46.1%, and 37.7% of patients achieved an HbA1c &amp;lt;7.0% in Group 1, 2, and 3, respectively (p=0.017; Group 2 vs. Group 3). Significantly more patients in Group 2 than in Group 3 (45.0% vs. 36.5%; p=0.014) achieved an HbA1c &amp;lt;7% without hypoglycemia (BG ≤3.0 mmol/L). Confirmed hypoglycemia (BG ≤3.9 mmol/L) was significantly more frequent in Group 1 vs. Group 3 (38.9 vs. 23.3%, p&amp;lt;0.001) but not in Group 2 vs. Group 3 (27.5% vs. 23.3%; p=0.177). Based on the lowest of 3 consecutive FBG values, the proportions of patients achieving an FBG within their target range at 24 weeks were 70.1%, 67.6% and 79.0% in Groups 1, 2 and 3, respectively. However, based on laboratory fasting plasma glucose (FPG) measurements, these proportions were 31.9%, 39.5% and 47.7%. After re-dividing by actual FPG level at 24 weeks, significantly more patients with an FPG ≤5.6 mmol/L (68.7%, p&amp;lt;0.001) and 5.6&amp;lt; FPG ≤6.1mmol/L (58.2%, p=0.013) achieved an HbA1c &amp;lt;7.0% than those with 6.1&amp;lt; FPG ≤7.0 mmol/L (43.6%). Conclusions: The optimal FBG target for the majority of patients with T2D appears to be ≤6.1 mmol/L. However, for patients at lower risk of hypoglycemia, an FBG target of ≤5.6 mmol/L may be appropriate. Disclosure W. Yang: Speaker's Bureau; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck &amp; Co., Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc., Sanofi, Servier. J. Ma: None. G. Yuan: None. L. Li: None. M. Zhang: None. Y. Lu: None. X. Ye: Speaker's Bureau; Self; AstraZeneca, Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc. W. Song: None. M. Liu: None. J. Wu: None. R. Chen: None. N. Cui: Employee; Self; Sanofi. Y. Li: Employee; Self; Sanofi. X. Zhang: None. J. Yang: None.

1014-P: Relationship between Glycemic Control and Weight Loss with Once-Weekly Efpeglenatide in Uncontrolled Type 2 Diabetes: A Subanalysis of EXCEED 203

Efpeglenatide (EFPEG) is a long-acting GLP-1 RA, administered by once-weekly (QW) subcutaneous injection, currently being developed to improve glycemic control in patients with T2D. EXCEED 203 (NCT02057172), a 12-week study of EFPEG (0.3, 1, 2, 3, or 4 mg QW) compared with placebo (PBO) and referenced to open-label liraglutide 1.8 mg in uncontrolled T2D (naïve/metformin monotherapy), found significantly improved HbA1c for all doses of EFPEG ≥1 mg, and reductions in body weight for EFPEG 3 and 4 mg. This exploratory subanalysis investigated any potential relationship between glycemic control and weight loss effects observed in EXCEED 203. At all EFPEG doses ≥1 mg and in two combined populations (low-dose group: EFPEG 1 and 2 mg; high-dose group: EFPEG 3 and 4 mg) vs. PBO, greater proportions of patients significantly achieved the composite endpoint of HbA1c &amp;lt;7% and weight loss &amp;gt;3 kg (p&amp;lt;0.05 for all; Table). Linear regression analysis revealed no correlation between change in HbA1c and change in body weight throughout the study for all EFPEG doses ≥1 mg. EFPEG was well tolerated with adverse events mirroring those known for GLP-1 RAs. In conclusion, EFPEG was associated with greater proportions of patients achieving the composite endpoint of HbA1c &amp;lt;7% and weight loss &amp;gt;3 kg vs. PBO without evidence that the glucose-lowering effects of EFPEG were dependent on weight loss. Disclosure J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck &amp; Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. C. Morales: Other Relationship; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi. U. Wendisch: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Eli Lilly and Company, Kowa Pharmaceutical Europe Co. Ltd., Lexicon Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S. Stock/Shareholder; Self; Novartis AG, Novo Nordisk A/S. G.E. Dailey: Research Support; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi US. Speaker's Bureau; Self; Sanofi US. M.E. Trautmann: Consultant; Self; CeQur Corporation, Hanmi Pharm. Co., Ltd., Intarcia Therapeutics, Inc., Oramed Pharmaceuticals, ProSciento, Servier. Stock/Shareholder; Self; Lilly Diabetes. M. Hompesch: Stock/Shareholder; Self; ProSciento. I. Choi: Employee; Self; Hanmi Pharm. Co., Ltd. J. Kang: Employee; Self; Hanmi Pharm. Co., Ltd. J.A. Stewart: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. I. Ogbaa: Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. Other Relationship; Self; Sanofi. C.H. Sorli: Employee; Self; Sanofi. K. Yoon: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc. Speaker’s Bureau; Self; Takeda Pharmaceutical Company Limited. Funding Hanmi Pharmaceutical, Co., Ltd.; Sanofi

2328-PUB: Identification by Multivariable Analysis of Predictive Factors of HbA1c Target Achievement in People with T2D Initiating Treatment with Insulin Glargine 300 U/mL (Gla-300)—REALI Pooled Database

REALI pooled database, encompassing Gla-300 studies conducted in different European countries, is a platform to identify factors contributing to glycemic control in patients with uncontrolled T2D initiated on Gla-300. A stepwise multivariable regression analysis was performed on selected demographic and baseline characteristics associated with achieving HbA1c target &amp;lt;7.5% after 6 months of Gla-300 treatment from 8 studies (3 interventional and 5 observational). The criterion for consideration and inclusion in the model was p &amp;lt; 0.05. Among 2558 subjects included, 48.7% reached target HbA1C &amp;lt;7.5%, 56% were male and 37% were insulin naïve. Mean (SD) age was 64 (9.4) years and BMI was 32.2 (5.3) kg/m2. Mean (SD) baseline HbA1c was 8.5 (1) % and starting Gla-300 dose 0.29 (0.18) U/kg/day. The analyses identified baseline HbA1c as the major predictive factor associated with achievement of HbA1c target &amp;lt;7.5%, with a nonlinear relationship, and odds were higher in the lowest baseline HbA1c value (p&amp;lt;0.0001). Male gender (p=0.0014), being insulin naïve (p&amp;lt;0.0001), and lower Gla-300 starting dose (p=0.0015) were also identified as potential predictors for achieving HbA1c target &amp;lt;7.5%. These results can help clinicians to identify patients with T2D treated with Gla-300, who are likely to achieve target HbA1c &amp;lt;7.5%. Disclosure N. Freemantle: Advisory Panel; Self; Sanofi. Research Support; Self; Akcea Therapeutics, Allergan, AstraZeneca, Ipsen Biopharmaceuticals, Inc., Sanofi, Takeda Pharmaceutical Company Limited. Speaker's Bureau; Self; Sanofi. G. Bigot: None. M. Bonnemaire: Employee; Self; Sanofi. D. Mauricio: Advisory Panel; Self; Merck Sharp &amp; Dohme Corp., Sanofi. Speaker's Bureau; Self; Almirall, S.A., Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi, Urgo Medical. R.C. Bonadonna: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Sanofi-Aventis. Speaker's Bureau; Self; Eli Lilly and Company, Sanofi-Aventis. P. Gourdy: Advisory Panel; Self; AstraZeneca. Board Member; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis, Servier. Speaker's Bureau; Self; Abbott, Amgen Inc., Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis, Servier. A. Ciocca: Employee; Self; Sanofi. D. Müller-Wieland: Advisory Panel; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. Funding Sanofi

1189-P: Effectiveness of Hydroxychloroquine (HCQ) 400 mg in Uncontrolled T2D Patients on Dual Therapy of Metformin and Sulfonylurea: A Real-World Experience in India

Objective: Many T2D patients have inadequate glycemic control despite conventional therapy of dual OHAs. Treating such patients in developing countries is a challenge as newer drugs are comparatively costly or patients may have apprehensions for injectable insulin. Objective of this observational study was to evaluate effectiveness of add-on therapy of HCQ in these patients. Methods: A prospective, observational, multi-centre study was conducted where 1,007 T2D patients (age between 18-65 years), uncontrolled on a combination of two OHAs, with HbA1c ≥7.5%, fasting blood glucose of ≥126 mg/dL or 2-hour blood glucose ≥200 mg/dL and body weight ≥60 kg were prescribed hydroxychloroquine sulphate 400 mg once daily for 24 weeks. Mean change in HbA1c, FBG, PPG, serum creatinine and lipid parameters were assessed. Results: At week 24, significant reduction in HbA1c (1.29%), FBG (18%), PPG (23%), TC (9%), LDL-C (12%) and non-HDL-C (12%) was observed (p &amp;lt; 0.0001). At the end of 24 weeks, 36.8% patients achieved HbA1c target of &amp;lt;7%. Conclusion: Hydroxychloroquine effectively improved glycemic and lipid parameters in uncontrolled T2D patients. It may emerge as a valuable therapeutic intervention for patients uncontrolled on two OHAs. Its beneficial effect on lipids may potentially translate to improved CV outcomes. Disclosure I. Purkait: Employee; Self; Ipca Laboratories Ltd. A. Pareek: Employee; Self; Ipca Laboratories Ltd. A. Panneerselvam: None. M.K. Mukhopadhyay: None. S. Kumar: Advisory Panel; Self; Abbott, Alere Inc., Alkem Laboratories, Eli Lilly and Company, Eris Lifesciences, Glenmark Pharmaceuticals Limited, Intas Pharmaceuticals Ltd., Johnson &amp; Johnson, Lupin Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi-Aventis, Sun Pharma, Torrent Pharma, USV Private Limited, Wockhardt, Zydus Pharmaceuticals, Inc. Consultant; Self; AstraZeneca, Biocon, Boehringer Ingelheim Pharmaceuticals, Inc., Dr. Reddys Laboratories. S.A. Chandratreya: None.

Comparing Treatment Strategies for Patients with Very Elevated HbA1c—A Randomized Trial

Basal-bolus insulin (BBI) is the most established treatment strategy for patients with very elevated HbA1c (&amp;gt;10%), especially if symptomatic. The combination of metformin (Met), GLP-1 receptor agonist (GLP-1RA) and basal insulin (BI) is a very effective glucose lowering strategy, but it has not been evaluated in patients with very elevated HbA1c. This is the first randomized trial comparing a GLP-1RA+BI treatment regimen to a BBI treatment regimen in patients with very uncontrolled (HbA1c&amp;gt;10%) T2D. Basal insulin detemir was either continued at the prior dose or initiated at 0.3 units/kg and self-titrated. GLP-1RA liraglutide was titrated according to label to 1.8 mg/day. Meal-time insulin aspart was initiated at 0.1 units/kg/meal and self-titrated. Metformin was continued or (re)initiated if tolerated, all other hypoglycemic agents were discontinued. The primary outcome was change in HbA1c at 6 months, analyzed using a mixed model repeated measures analysis. We randomized 120 patients with a mean age (SD) 47.4 (9.5) years, Hispanic 48%, diabetes duration of 10.54 (7.19) years, 76% were already treated with insulin, HbA1c 12.1 (1.4) %, BMI 37.2 (10.3) kg/m2, 86% had one or more symptoms of hyperglycemia. Both treatment strategies lead to dramatic improvements in HbA1c, treatment with GLP-1RA+BI, compared with BBI, resulted in significantly better glycemic control, weight, insulin dosage, and hypoglycemia (Table).Table. Effects of treatment with GLP-1RA + basal insulin (GLP1RA+BI) compared with basal-bolus insulin (BBI) on primary &amp; secondary outcomes.VariableGLP1RA+BI GroupBBI GroupEstimated Treatment DifferenceP value between groupsBaseline6 monthsBaseline6 monthsHbA1c(%)12.2 (11.8 to 12.6)8.1 (7.4 to 8.7)11.8 (11.5 to 12.2)8.8 (6.0 to 9.1)1.1 (0.1 to 2.0)0.03Weight (kg)98.2 (89.7 to 106.6)97.5 (89.1 to 106.0)104.5 (96.2 to 112.8)107.6 (99.3 to 115.9)3.7 (1.53 to 5.9)&amp;lt;0.01TDD Insulin (U/day) (median, 25th to 75th percentile)25.0 (22.0 to 36.0)64.0 (39.5 to 80.0)60.0 (43.0 to 72.0)100.0 (66.0 to 155.0)0.3* (0.1 to 0.5)0.01HbA1c ≤7% N (%)NA20 (44.4)NA9 (20.5)Odds Ratio 0.32 (0.13 to 0.82)0.02Patients with any hypoglycemia (glucose &amp;lt;70 mg/dL) N (%)NA19 (35.2)NA37 (66.1)NA&amp;lt;0.01Data represents Least Squares Means (95% confidence intervals) unless otherwise noted.*ETD for the log transformed value Disclosure M. Abreu: None. A. Tumyan: None. A. Elhassan: None. O. Papacostea: None. K. Peicher: None. P. Dimachkie: None. M.S. Siddiqui: None. B. Adams-Huet: None. X. Li: None. L. Pop: None. I. Lingvay: Advisory Panel; Self; Novo Nordisk A/S, Eli Lilly and Company, AstraZeneca, Intarcia Therapeutics, Inc., Sanofi-Aventis. Research Support; Self; Novo Nordisk A/S, Merck Sharp &amp; Dohme Corp., Pfizer Inc., GI Dynamics Inc., Novartis AG. Other Relationship; Self; Sanofi, AstraZeneca, Boehringer Ingelheim GmbH, Novo Nordisk A/S.

COMRADE: A randomized trial of an individually tailored integrated care intervention for uncontrolled type 2 diabetes with depression and/or distress in the rural southeastern US

BackgroundEmerging evidence suggests that people living with Type 2 diabetes mellitus (T2D) are also at greater risk for depression and distress. If left untreated, these comorbid mental health concerns can have long-lasting impacts on medical and physical health outcomes. DesignThis prospective trial randomized rural men and women with uncontrolled T2D (HbA1c ≥ 7.0) who screened positive for co-morbid depressive (PHQ-2 > 3) or distress (DDS-2 > 3) symptoms in a primary medical care setting to receive either: 1) 16 sessions of cognitive and/or behavioral intervention tailored to symptom severity across 12 months along with routine medical care, or 2) usual primary care. Outcomes included change from baseline to 12-months in HbA1c, diabetes related distress, depressive symptoms, and diabetes self-care activities. Baseline results139 patients (Mean age = 52.6 ± 9.6 years) with T2D from impoverished rural communities were enrolled (almost half reporting annual income of <$10,000 per year). Baseline data indicated that patients were experiencing profoundly uncontrolled T2D of a long duration (Mean HbA1c = 9.61 ± 2.0; Mean BMI = 37.0 ± 9.1; Mean duration = 11.2 ± 8.9 years) along with high levels of distress (Mean DDS-17 Scale Score = 2.5 ± 1.0) and/or depressive symptoms (Mean PHQ-9 Scale Score = 9.3 ± 6.1). ConclusionPatients with uncontrolled T2D of long duration manifest complex co-morbidities including associated obesity, depressive symptoms and/or diabetes related distress. A behavioral intervention for T2D that concurrently targets symptoms of depression and distress may lead to more effective outcomes in this high-risk population. Clinical trial registrationNCT02863523.

A Systematic Review: Family Support Integrated with Diabetes Self-Management among Uncontrolled Type II Diabetes Mellitus Patients.

The rate of type-2 diabetes mellitus (T2D) is dramatically increasing worldwide. Continuing diabetes mellitus (DM) care needs effective self-management education and support for both patients and family members. This study aimed to review and describe the impacts of diabetes mellitus self-management education (DSME) that involve family members on patient outcomes related to patient health behaviors and perceived self-efficacy on self-management such as medication adherence, blood glucose monitoring, diet and exercise changes, health outcomes including psychological well-being and self-efficacy, and physiological markers including body mass index, level of blood pressure, cholesterol level and glycemic control. Three databases, PubMed, CINAHL, and Scopus were reviewed for relevant articles. The search terms were “type 2 diabetes,” “self-management,” “diabetes self-management education (DSME),” “family support,” “social support,” and “uncontrolled glycaemia.” Joanna Briggs Institute (JBI) guidelines were used to determine which studies to include in the review. Details of the family support components of DSME intervention and the impacts of these interventions had on improving the health outcomes patients with uncontrolled glycaemia patients. A total of 22 intervention studies were identified. These studies involved different DSME strategies, different components of family support provided, and different health outcomes to be measured among T2D patients. Overall, family support had a positive impact on healthy diet, increased perceived support, higher self-efficacy, improved psychological well-being and better glycemic control. This systematic review found evidence that DSME with family support improved self-management behaviors and health outcomes among uncontrolled glycaemia T2D patients. The findings suggest DSME models that include family engagement can be a useful direction for improving diabetes care.