On Oral Antidiabetic Drugs Research Articles

Comparative efficacy and safety of Gla-300 versus IDegAsp in insulin-naïve people with type 2 diabetes mellitus uncontrolled on oral anti-diabetics.

To compare the efficacy and safety of insulin glargine-300 once daily (Gla-300) with insulin degludec/aspart (IDegAsp) once daily in patients with type 2 diabetes (T2D) inadequately controlled on oral anti-diabetic drugs (OADs). A systematic literature review of randomized controlled trials was followed by an indirect treatment comparison of studies involving insulin naïve adults, inadequately controlled [glycated haemoglobin (HbA1c) ≥7.0%] on OADs, who received Gla-300 or IDegAsp once daily. Outcomes of interest were change in HbA1c, blood glucose, weight and insulin dose, as well as incidence and event rate of hypoglycaemia and other adverse events. Four trials with broadly similar baseline patient characteristics were included in the meta-analyses and indirect treatment comparison. At 24-28 weeks, the indirect comparison of Gla-300 to IDegAsp once daily estimated no statistically significant difference for change in HbA1c (%) from baseline [mean difference of 0.10% (95% CI: -0.20, 0.39; p = .52)]; a statistically significant mean difference of -1.31 kg (95% CI: -1.97, -0.65; p < .05) for change in body weight from baseline; statistically significant odds ratios of 0.62 (95% CI: 0.41, 0.93; p < .05) for incidence of any hypoglycaemia; and 0.47 (95% CI: 0.25, 0.87; p < .05) for incidence of anytime confirmed hypoglycaemia (plasma glucose <3.0-3.1 mmol/L). No significant differences were observed for insulin dose and adverse events. In insulin-naïve patients with T2D inadequately controlled on OADs, commencing Gla-300 shows a comparable HbA1c reduction, but with significantly less weight gain and a lower incidence of any and confirmed hypoglycaemia compared with commencing IDegAsp.

ODP620 A Cross-over Trial Using Insulin Glargine And Neutral Protamine Hagedorn Insulin For The Poorly Controlled Patients With Type 2 Diabetes Who Refused Multiple Daily Insulin Injections

Abstract A Cross-Over Trial Using Insulin Glargine and Neutral Protamine Hagedorn insulin for the Poorly Controlled Patients with Type 2 Diabetes Who Refused Multiple Daily Insulin Injections Background: Data in the literature describing the comparison between Neutral Protamine Insulin of Hagedorn (NPH) and glargine insulins are conflicting. While some studies revealed the superiority of Glargine, others had shown comparable results and even NPH superiority figures. We have many patients on NPH basal therapy in our clinical practice and another good number on Glargine. We did observe adverse effects in both groups, but local data and real numbers comparing both regimens are lacking. Objective To compare basal insulin regimen using NPH or Glargine in efficacy, hypoglycaemic events, and weight gain. Design and setting: A prospective interventional crossover study was conducted in Faiha Specialized Diabetes, Endocrine and Metabolism Center from 2018 through 2021, involving patients less than 65 years old with uncontrolled Type 2 Diabetes Mellitus whose HbA1c &amp;gt;10% on oral antidiabetic drugs (OAD); randomized into two groups (G1 &amp; G2), 70 patients in each group had completed the study, one group received NPH and the other received Glargine in addition to their OAD for one year, then they were crossed over for another one year after a period of washout. Results The mean age was 48.9±5.5 and 45.9±4.1 years for G1 and G2, respectively. 36(51.4%) in G1 were women versus 27(38.6%) in G2. In the first phase of the study, HbA1c reduction was 5.5±1.1% for the NPH group and 5.3±1.1% for the Glargine group (p=0.418), there was 1.7±2.7 versus 1.1±2.9 Kg weight gain (p=0.209), 27(39.7%) hypoglycemic event versus 26(37.7%) (p=0.883) and 5 patients(7.4%) achieved HbA1c &amp;lt;7% versus 8(11.6%) (p=0.397) for the patients in NPH and Glargine groups respectively. While in the crossover phase, the data comparing Glargine and NPH groups are as following: 0.6±0.8 versus 0.5±0.9% reduction in HbA1c (p=0.413), 1.7±3.1 versus 0.6±2.2 Kg weight loss (p=0. 035) although the final weight was not much different 77.3±12. 0 versus 77.7±11.5 (p=0.841), 16(27.1%) versus 23(36.5%) hypoglycemic events (p=0.493) and 17(29.8%) versus 11(17.7%) achieved HbA1c&amp;lt;7% (p=0.121) respectively. Conclusion In our study, there was no significant difference in HbA1c reduction, Hypoglycemic events, and weight gain between patients using NPH or Glargine basal insulin regimen. Keywords: Diabetes; Glargine; NPH. Presentation: No date and time listed

Comparison of glycemic variability in type 2 diabetes mellitus patients on oral anti diabetic drugs (OAD) with and without insulin using ambulatory glucose profile (AGP)

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Serum Glucose Measurement after Five to Six Hours is Comparable to Eight Hours Fasting in Ramadan.

ObjectivesThis study aimed to evaluate whether a shorter fasting duration of five to six hours can be used as an alternative to the usually recommended eight hours for fasting glucose measurement.MethodsThis one-month observational, cross-sectional study was conducted during Ramadan (May to June) 2019. It included those attending Faiha Specialized Diabetes, Endocrine and Metabolism Center, Basrah, Iraq; all individuals ate a pre-dawn meal (suhoor) followed by a complete fast for many hours. Two fasting serum glucose (FSG) venous samples were taken; the first was taken five to six hours and the second eight hours after the pre-dawn meal. Participants were divided into two groups: individuals with type 2 diabetes mellitus (T2DM) and those with a normal glucose level. T2DM patients were further subdivided into three groups: those without treatment, those on oral antidiabetic drugs (OAD) and those using insulin and OAD.ResultsA total of 200 individuals participated in this study. There was no significant difference found between the mean FSG levels in the first and second samples for those without T2DM (104.5 ± 21.4 mg/dL versus 104.8 ± 12.6 mg/dL; P = 0.80) as well as those with T2DM (235.0 ± 107.0 mg/dL versus 230.0 ± 105.0 mg/dL; P = 0.20). Untreated T2DM patients had non-significant FSG readings for the two samples (194.0 ± 151.5 mg/dL versus 193.9 ± 128.9 mg/dL; P = 0.90). Patients on insulin and OAD showed a similar pattern of FSG (268.0 ± 111.0 mg/dL versus 269.0 ± 114.0 mg/dL). However, the two FSG samples were found to be significantly different among patients on OAD (220.0 ± 78.0 mg/dL versus 207.0 ± 77.0 mg/dL; P = 0.01).ConclusionThe fasting duration of five to six hours can give a comparable measurement of FSG as that obtained after eight hours.

POSC141 Evaluation of the Long-Term Cost-Effectiveness of Ideglira Versus Liraglutide for Patients with Type 2 Diabetes Uncontrolled on Oral Antidiabetic Drugs in China

To assess the long-term cost-effectiveness of the insulin degludec/liraglutide combination (IDegLira) versus liraglutide for patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OAD) in China.

Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicentre study: The LixiLan JP-O2 randomized clinical trial.

To assess efficacy and safety of 26-week treatment with insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with insulin glargine U100 (iGlar) in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs). This phase 3, multicentre, open-label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL). The primary endpoint was change in HbA1c from baseline to week 26. Patients were randomized to iGlarLixi (n = 260) or iGlar (n = 261) (mean age 59.7 years, baseline BMI 26.04 kg/m2 , and HbA1c 8.04% [64.4 mmol/mol]). HbA1c reduction was significantly greater with iGlarLixi (-1.40% [-15.3 mmol/mol]) than with iGlar (-0.76% [-8.3 mmol/mol]). Significantly more iGlarLixi patients reached HbA1c <7% at week 26 (71.5% vs 38.5%, P < .0001), with significantly lower weight gain (LS mean difference -1.06 kg, P < .0001). Documented symptomatic hypoglycemia (plasma glucose ≤3.9 mmol/L [70 mg/dL]) was recorded in 14.2% of patients with iGlarLixi and 12.3% with iGlar. No severe hypoglycemia was reported in either group. Other than the expected gastrointestinal issues associated with glucagon-like peptide 1 receptor agonists, we found no major difference in the incidence of TEAEs. HbA1c reduction was significantly greater with iGlarLixi than with iGlar; significantly more patients achieved HbA1c <7%, with no additional risk of hypoglycemia and without weight gain. iGlarLixi (1:1) provided an effective treatment option for Japanese patients with T2DM inadequately controlled on OADs. Clinical Trial Number: NCT02752828.

Lixisenatide for Type 2 Diabetes Mellitus Patients Inadequately Controlled on Oral Antidiabetic Drugs: A Mixed-Treatment Comparison Meta-analysis and Cost-Utility Analysis.

IntroductionThe aim of this study was to compare the efficacy, safety and cost-utility (from the Chinese health insurance perspective) of lixisenatide and insulin regimens in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).MethodsA comprehensive literature search of English (PubMed and Cochrane Library) and Chinese (CNKI and WanFang) language databases was performed, and head-to-head relevant randomized controlled trials (RCTs) were retrieved and analyzed by performing a mixed-treatment comparison (MTC) meta-analysis for efficacy and safety endpoints. A cost–utility analysis was then conducted using the IQVIA CORE Diabetes Model to compare the lifetime pharmacoeconomic profiles among the treatment groups.ResultsEleven RCTs were included in this MTC meta-analysis. Regarding glycated hemoglobin targets, lixisenatide was similar to both basal insulin (mean difference [MD] 0.27%; 95% credible interval [CrI] 0.02%, 0.57%) and premixed insulin (MD 0.32%; 95% CrI − 0.01%, 0.66%), respectively. Statistically significant differences were found for changes in body weight in favor of lixisenatide compared with basal insulin (MD − 3.22 kg; 95% CrI − 5.51 kg, − 0.94 kg) and premixed insulin (MD − 2.68 kg; 95% CrI − 5.16 kg, − 0.20 kg). The relative risk (RR) of symptomatic hypoglycemia associated with lixisenatide was also significantly lower than that associated with basal insulin (RR 0.22; 95% CrI 0.09, 0.52) and premixed insulin (RR 0.17; 95% CrI 0.07, 0.41). The cost–utility analysis yielded results of ¥61,072 ($8565, vs. basal insulin) and ¥127,169 ($17,836, vs. premixed insulin) per quality-adjusted life year gained, with both values falling within the willingness-to-pay threshold in China.ConclusionsFor T2DM patients inadequately controlled on OADs, lixisenatide was shown to be comparable to basal insulin and premixed insulin in terms of HbA1c and better than both of the latter in terms of both body weight loss and hypoglycemia. Lixisenatide was also a cost-effective treatment option from the perspective of Chinese health insurance.Electronic Supplementary MaterialThe online version of this article (10.1007/s13300-020-00857-3) contains supplementary material, which is available to authorized users.

Six Months Comparative Evaluation of Efficacy and Safety of Wockhardt's Biosimilar Insulin Glargine (Glaritus&amp;reg;) with Reference Insulin Glargine (Lantus&amp;reg;) in Type 2 Diabetes Mellitus in India: Results of Interim Analysis

Objective: To compare the change in immunogenic response, safety and efficacy of insulin glargine in Glaritus® and Lantus® treatment arms from baseline to six months in patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs). Material and methods: In an ongoing prospective, open-label, randomized, parallel-group, comparative, multicenter, phase IV study, adult patients with uncontrolled T2DM are treated with either Glaritus® once daily or Lantus® once daily for six months, both given subcutaneously. Glaritus® treatment arm is to be continued for another six months. The primary endpoint for the study was the percentage change in anti-insulin antibodies (AIA) titer to glargine in both treatment arms from baseline to six months. Results: Ninety patients were randomized to each group. Baseline characteristics were comparable between the groups (p>0.05). There was no significant difference in percent change in the AIA titer between the two treatment arms at the end of six months in ITT (intent-to-treat) and mITT(modified intent to treat) population (LS mean diff [95% CI]: 2.2% (-15.1%, 19.6%), p=0.7987 and 3.4% (-15.1%, 21.9%), p=0.7181, respectively). No significant between-group difference was seen in change in the HbA1c level at the end of six months in ITT and mITT population [LS mean diff (95% CI): -0.2 (-0.4, 0.0), p=0.1072 for ITT population; and -0.1 (-0.3, 0.1), p=0.2283, for mITT population]. There was also no significant difference between two groups for the incidence of adverse events [Glaritus® 17 (18.9%) and Lantus® 20 (22.2%) p=0.5800]. Conclusion: Glaritus® was found to be non-inferior to Lantus® in glycaemic control and comparable in immunogenic response and safety at the end of six months in patients with T2DM uncontrolled on OADs.

A greater proportion of participants with type 2 diabetes achieve treatment targets with insulin degludec/liraglutide versus insulin glargine 100 units/mL at 26 weeks: DUAL VIII, a randomized trial designed to resemble clinical practice.

This report presents the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as initial injectable therapy at 26 weeks in the 104‐week DUAL VIII durability trial (NCT02501161). Participants (N = 1012) with type 2 diabetes (T2D) uncontrolled on oral antidiabetic drugs (OADs) were randomized 1:1 to open‐label IDegLira or IGlar U100. Visits were scheduled at weeks 1, 2, 4 and 12, and every 3 months thereafter. After 26 weeks, glycated haemoglobin (HbA1c) reductions were greater with IDegLira versus IGlar U100 (−21.5 vs. –16.4 mmol/mol [−2.0 vs. –1.5%]), as was the percentage of participants achieving HbA1c <53 mmol/mol (78.7% vs. 55.7%) and HbA1c targets without weight gain and/or hypoglycaemia. Estimated treatment differences for insulin dose (−13.01 U) and body weight change (−1.57 kg) significantly favoured IDegLira. The hypoglycaemia rate was 44% lower with IDegLira versus IGlar U100. Safety results were similar. In a trial resembling clinical practice, more participants receiving IDegLira than IGlar U100 met treatment targets, supporting use of IDegLira as an initial injectable therapy for people with T2D uncontrolled on OADs and eligible for insulin initiation.

Effectiveness and safety of insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes after failure of oral therapy in a real-world setting.

AimTo evaluate the effectiveness and safety of initiating basal insulin‐supported oral therapy (BOT) with insulin glargine 300 U/mL (Gla‐300) in patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs (OADs).Materials and MethodsThis non‐interventional, multi‐centre, prospective 52‐week study, conducted in Germany and Switzerland, documented patients with type 2 diabetes with an HbA1c of between 7.5% and 10.0%, currently treated with OADs, after the physician had decided to start a BOT regimen with Gla‐300. The primary endpoint was the rate of achievement of the individualized predefined HbA1c target.ResultsOf 1748 patients included, 1153 comprised the full analysis set, of whom 721 completed documentation of 12 months of Gla‐300 treatment. Twelve months after starting Gla‐300, 49.9% achieved their individualized HbA1c target, and 61.1% achieved either their HbA1c target or a fasting plasma glucose (FPG) of ≤110 mg/dL. Mean HbA1c decreased by −1.22% ± 1.05% to 7.28% ± 0.92% and mean FPG by −51.5 (±48.63) mg/dl to 132.9 ± 33.0 mg/dL. Median duration of HbA1c target achievement was 341 days and probability to remain on target after 6 months was 81%. Hypoglycaemia incidence and rates remained low after 12 months of Gla‐300 treatment; no severe or severe nocturnal hypoglycaemia was observed. Body weight remained unchanged.ConclusionsStarting a BOT regimen with Gla‐300 allowed about 60% of 721 German and Swiss patients with inadequately controlled type 2 diabetes to achieve glycaemic control within 12 months in daily clinical practice. Glycaemic control was achieved without weight gain or increased risk of nocturnal or severe hypoglycaemia.

Association between Macronutrient Intake Pattern, Glycemic Status and Use of Antidiabetic Drugs among Type 2 Diabetes Patients

The study was aimed to assess the macronutrient intake pattern and its association to glycemic status and drug intake pattern of type 2 diabetes patients. Forty five subjects (25 males and 20 females) aged between 30 and 60 years, diagnosed with diabetes for less than 3 years were enrolled into the study. Based on Oral Anti-Diabetic drugs (OAD) treatment, they were grouped as those on mono-therapy (GpI, n=21) and dual therapy (GpII, n=25). Information about drugs profile, macronutrient intake (3 days diet recall reported as % equivalent of energy) and serum glucose profile were obtained at baseline and a 6th month follow up. Mean CHO, protein and fat intakes were 65.4±4.84, 12.6±1.26 and 22.0±4.7 % of total energy at baseline and remained essentially similar at 6&lt;sup&gt;th&lt;/sup&gt; month. Patients who had controlled glycemic status (HbA&lt;sub&gt;1C &lt;/sub&gt;≤ 7 %) consumed 63.4±2.70 % CHO which was significantly (P&amp;lt;0.05) lower than those with not&lt;strong&gt;-&lt;/strong&gt;controlled glycemic status (HbA&lt;sub&gt;1C &lt;/sub&gt;&amp;gt;7 %) during both the assessment periods. Also, mean protein intake was higher and fat intake was lower among patients with good glycemic control. Significantly a higher proportion of (P&amp;lt;0.05) patients consuming CHO &amp;gt; 65 % were on dual therapy. A diet with lower carbohydrates and fat but high protein exerted good glycemic control. Number of OADs and their dosages were significantly associated to CHO intakes. Since Indian diets are predominantly carbohydrate rich, it calls for a careful management of diet among Type 2 diabetes patients

Titration of insulin glargine 100U/mL when added to oral antidiabetic drugs in patients with type 2 diabetes: results of the TOP-1 real-world study.

Adequate insulin titration is crucial for optimal glycaemic control in type 2 diabetes (T2D). We aimed to explore the factors and outcomes associated with titration of glargine 100U/mL (Gla-100) in patients uncontrolled on oral antidiabetic drugs (OAD) and initiating insulin therapy. Patients from the Titration and Optimization (TOP)-1 registry were stratified by the magnitude of Gla-100 up-titration during the first month (no [< 1Units (U)/day (d)], minimal [≥ 1 and < 5U/d], moderate [≥ 5 and ≤ 8U/d] and strong [> 8U/d]). The primary endpoint was a fasting blood glucose (FBG) ≤ 110mg/dL on ≥ 2 occasions and/or individual HbA1c target by 12months. Of 2308 patients, 905, 715, 409 and 279 underwent no, minimal, moderate and strong titration, respectively. Age decreased across increasing titration groups (p = 0.02) while body mass index (BMI) (p < 0.0001), FBG (p < 0.0001), and HbA1c (p < 0.0001) increased. At 12months, the proportions of patients achieving the primary endpoint were comparable across groups (66.1% overall), though a smaller proportion of no titration patients met both their individual HbA1c target and FBG ≤ 110mg/dL compared to moderate and strong titration patients (20.1% vs. 27.2% and 26.2%, p = 0.033 and 0.023, respectively). HbA1c was also comparable, though FBG was higher in the no titration group (126.2 vs. 122.6, 121.5 and 120.9mg/dL, p < 0.02). A similar, small reduction in body weight occurred in all groups; hypoglycaemia rates were comparable across groups. In real-world, titration of Gla-100 during the first month appears to coincide with a number of baseline factors. Insulin dose to meet HbA1c and FBG targets remains suboptimal in the majority of T2D patients.

1111-P: The Qualitative and Quantitative Effect of IDegLira Compared with the Nonfixed Administration of Degludec and Liraglutide

Background: The efficacy and safety of IDegLira and the benefits of its complementary mode of action have been examined in the large global DUAL clinical trial program. Aim: The aim of this study is to examine the effect of the IDegLira on the glycemic control and the cardiometabolic risk factors compared to the non-fixed adiministration of degludec and liraglutide. Material and Methods: 473 patients with type 2 diabetes mellitus (T2DM) were included in the study. 158 patients on oral antidiabetic drugs (OADs) switched to OADs and IDegLira (Group A), 163 under OADs and liraglutide treatment added degludec to their regimen (Group B) and in 152 patients using degludec and OADs, liraglutide was added (Group C). Follow-up period was 52 ±2 weeks and changes in HbA1c, cardiometabolic risk factors and treatment adherence (with the 8-item Morisky Medication Adherence Scale (MMAS-8)) were recorded. Results: There was no difference at baseline between the three groups as to age (61.88 ± 9.98 years, p =0.212), diabetes duration (12.08 ± 5.83, p = 0.332), HbA1c (mean HbA1c: 8.59± 1.13, p = 0.118) καιΒΜΙ (BMI 32.08 ± 3.22, p = 0.144). Mean HbA1c levels after the follow-up period was 6.79 ± 0.77, 7.14 ± 1.19, 7.18 ± 1.07 (p = 0.033) for Group A, B and C, respectively. Most of patients in Group A reached the treatment target for HbA1c (p = 0.041). Weight change was -3.2 ± 1.2 kg for Group A, -1.2 ± 1.1 kg for Group B and -4.3 ± 1.7 kg for Group C (p &amp;lt; 0.001). There was no difference in the hypoglycemic episodes between the groups (p = 0.251). The highest levels of adherence were noticed in Group A compared to Group B and C (7.58 ± 1.08, 6.38 ± 1.28 and 6.44 ± 1.16, p = 0.031, respectively) while total insulin dose was lower for Group A compared to the other groups (p=0.041). Conclusion: Uncontrolled patients on oral antidiabetic drugs when switched to an IDegLira regimen achieved a significant improvement in their glycemic control and a more significant adherence compared the non-fixed combination of degludec and liraglutide. Disclosure A. Koutsovasilis: None. A. Sotiropoulos: None. A. Antoniou: None. M. Pappa: None. S. Bousboulas: None. T. Peppas: None.

147-OR: DUAL VIII: Significantly Longer Time to Treatment Intensification with Insulin Degludec/Liraglutide (IDegLira) vs. Insulin Glargine (IGlar U100) in a 104-Week (Wk) Randomized Trial Mirroring Clinical Practice

Patients (pts) (n=1012) with T2D (A1C 7-11%) on oral antidiabetic drugs (OADs) were randomized 1:1 to open label IDegLira or IGlar U100 in a 104 week trial to assess treatment durability. The primary endpoint was time from randomization to treatment intensification (A1C ≥7.0% at 2 consecutive visits including week 26); pts who met the primary endpoint discontinued study drug. Baseline characteristics were similar. Over 104 weeks, fewer pts with IDegLira required intensification vs. IGlar U100 (37.4% vs. 66.2%). Pts treated with IDegLira had a significantly longer time to intensification (median: &amp;gt;2 years/~1 year for IDegLira/IGlar U100; Figure). There was greater effect with IDegLira vs. IGlar U100 after 104 weeks, had intensification not been needed, in terms of: pts achieving A1C &amp;lt;7% (55.7 vs. 28.5%), and A1C &amp;lt;7% with no weight gain (20.9 vs. 6.3%), lower estimated mean insulin dose (36 vs. 51 U; estimated treatment difference -14.9 U), and 56% lower rate of severe or blood glucose confirmed symptomatic hypoglycemia (0.38 vs. 0.86 events/patient-year of exposure, (p&amp;lt;0.0001 for all). Safety results were similar. Improved long-term glycemic control, evidenced by significantly longer time to treatment intensification, was achieved with IDegLira vs. IGlar U100 in pts previously uncontrolled on OADs. Disclosure V.R. Aroda: Consultant; Self; ADOCIA, AstraZeneca, Becton, Dickinson and Company, Novo Nordisk Inc., Sanofi, Zafgen, Inc. Employee; Spouse/Partner; Merck &amp; Co., Inc. Research Support; Self; AstraZeneca, Calibra Medical, Eisai Inc., Janssen Research &amp; Development, Novo Nordisk Inc., Sanofi, Theracos, Inc. G. Gonzalez-Galvez: Advisory Panel; Self; Amgen Inc., AstraZeneca, Janssen Pharmaceuticals, Inc., Metabolic Solutions Development Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. Consultant; Self; Amgen Inc., AstraZeneca, Janssen Pharmaceuticals, Inc., Metabolic Solutions Development Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Metabolic Solutions Development Company, Novo Nordisk A/S, Sanofi-Aventis, Takeda Pharmaceutical Company Limited. M. Haluzik: Advisory Panel; Self; AstraZeneca, Medtronic, Merck &amp; Co., Inc., Novo Nordisk A/S, Sanofi. Consultant; Self; Johnson &amp; Johnson, Lilly Diabetes. Speaker's Bureau; Self; Novartis AG. R.J. Silver: Consultant; Self; Novo Nordisk A/S. Speaker's Bureau; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S. R. Grøn: Employee; Self; Novo Nordisk A/S. N. Halladin: Employee; Self; Novo Nordisk A/S. P. Örsy: Employee; Self; Novo Nordisk A/S. G. Sesti: Advisory Panel; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, GlaxoSmithKline plc., Novo Nordisk A/S, Servier. Consultant; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, GlaxoSmithKline plc., Novo Nordisk A/S, Servier. Funding Novo Nordisk A/S

Selfmonitoring of blood glucose practices by people living with diabetes who use their personal glucometers in Port Harcourt, Niger Delta Region, Nigeria

Self-monitoring of blood glucose (SMBG) assists persons living with diabetes with the day-to-day behavioral and therapeutic adjustments to their diabetes care. It is a cheaper and more available alternative to glycated haemoglobin (HbA1c) in Nigeria for monitoring glycaemic control. Information on SMBG practices of Nigerians living with diabetes using their personal glucometers is scanty. The aim of the study is to assess the intensity and frequency of SMBG by glucometer owners, and the extent the patients and/or the health care providers (HCP) utilize SMBG to achieve personalized treatment goals via behavioral/treatment adjustments. This was a cross sectional study carried out among persons living with diabetes that accessed diabetes care at the diabetes clinic of the University of Port Harcourt Teaching Hospital (UPTH) and using their personal glucometers. They were consecutively recruited. Data obtained by using intervieweradministered questionnaires were analyzed using SPSS version 20.0, and pvalue &lt;0.05 was considered significant. A total of 128 persons living with diabetes participated in the study of which 40 (31%) were males and 88 (69%) were females; the mean age of the subjects was 52.05 ± 11.24 years with a range of 26–70 years. The majority of the study subjects (72%) were in the active working age group (25–60years). The highest frequency of glucometer use was in the 26 subjects (20%) who checked their blood glucose every morning while 62 (48%) of the subjects checked their blood glucose any morning they felt like. Most of the subjects (60%) did not have any recording device. Glucometer owners were not just the insulin-requiring people living with diabetes as more than half of the subjects, 66 (52%) were on oral anti diabetic drugs (OAD) only. Glucometer ownership was mainly by those that were in the working age group. SMBG protocol (frequency) was variable and SMBG data were not maximally utilized.Keywords: Self-monitoring of blood glucose; Personal glucometer; Diabetes; Blood glucose

Qualitative and Quantitative Effect of IDegLira Compared with the Nonfixed Administration of Degludec and Liraglutide

Introduction: The efficacy and safety of IDegLira and the benefits of its complementary mode of action have been examined in the large global DUAL clinical trial program. Aim: The aim of this study is to examine the qualitative and quantitative effect of IDegLira compared to the non-fixed adiministration of degludec and liraglutide. Methods: Uncontrolled type 2 diabetes (T2D) patients (n=473) were included in the study. 158 patients on oral antidiabetic drugs (OADs) switched to OADs and IDegLira (Group A), 163 on OADs and liraglutide switched to degludec and the existing therapeutic regime (Group B) and 152 patients on degludec and OADs switched to liraglutide and the existing treatment (Group C). All patients also received metformin while none of them received sulfonylurea. Follow-up was 12 months and changes in HbA1c, cardiometabolic risk factors, and treatment adherence (with the 8-item Morisky Medication Adherence Scale) were recorded. Results: There was no difference at baseline between the three Groups as to age (p=0.224), diabetes duration (p=0.322), HbA1c (8.56±1.12, p=0.116) and BMI (32.14±3.56, p=0.142). The mean HbA1c after 12 months was 6.79±0.77, 7.14±1.19, 7.18±1.07 (p=0.033) for Groups A, B and C respectively. More patients achieved the therapeutic target for HbA1c in Group A (p=0.048). The weight change was -3.2±1.2 Kg for Group A, 1.2±1.1 Kg for Group B and -4.3±1.7 Kg for Group C (p&amp;lt;0.001). There was no difference in the hypoglycemic episodes between the three Groups (p=0.251). Greater adherence was achieved in Group A compared to Group B and C (7.58±1.08, 6.38±1.28 and 6.44±1.16, p=0.031). Total insulin dose was lower for Group A (p=0.040). Conclusions: Uncontrolled patients on oral antidiabetic drugs when switched to a therapeutic regimen with IDegLira achieved a significant improvement in their glycemic control with a significant adherence to their therapeutic regimen while the adherence in a non-fixed combination was not significant enough. Disclosure A. Koutsovasilis: None. A. Sotiropoulos: None. D. Papadaki: None. E. Bletsa: None. G. Kokotos: None. I. Kounelakis: None. S. Bousboulas: None. T. Peppas: None.

Initiating Basal Insulin Supported Oral Therapy (BOT) with Insulin Glargine 300 U/mL (Gla-300) Improves Glycemic Control in Patients (Pts) with Type 2 Diabetes (T2DM) without Increasing Hypoglycemia Risk

Toujeo-1, a prospective observational study, investigates the effects of initiating BOT with Gla-300 in insulin-naïve pts with T2DM in Germany (n=1,680) and Switzerland, insufficiently controlled (A1c 7.5-10%) on oral antidiabetic drugs (OADs) in daily clinical practice. Primary endpoint (EP) is the proportion of pts achieving individualized A1c targets after 6 and 12 months, respectively. Secondary EPs include changes in A1c, fasting plasma glucose (FPG), body weight (BW) and insulin dose, hypoglycemia incidence and safety. Here we report results of pts recruited at German sites with 12 months results available (n=674). Pts baseline characteristics, efficacy and hypoglycemia EPs are shown in Table 1. Main OAD treatments were metformin ± DPP-4 inhibitors (49.4%). Twelve months after initiating Gla-300 therapy, proportions of pts at target were 48.4% (A1c at individual target), 30.5% (FPG ≤110 mg/dL), and 60.3% (A1c or FPG at target), respectively. Hypoglycemia rates were low (≤0.events/patient year) and no severe (nocturnal) hypoglycemia was reported. BW remained stable. In conclusion, initiating BOT with Gla-300 allowed insulin-naïve, uncontrolled T2DM pts to reduce their A1c by 1.20% w/o increasing hypoglycemia risk, especially w/o increase in severe (nocturnal) hypoglycemia. Disclosure M. Pfohl: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; Sanofi. A. Fritsche: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Novo Nordisk A/S, Eli Lilly and Company, Boehringer Ingelheim GmbH. H. Anderten: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp &amp; Dohme Corp.. Speaker's Bureau; Self; Sanofi-Aventis Deutschland GmbH, Merck Sharp &amp; Dohme Corp., Eli Lilly and Company, Boehringer Ingelheim GmbH, Pfizer Inc., AstraZeneca, GlaxoSmithKline plc., Novartis AG, Novo Nordisk A/S, Takeda. K. Pegelow: Employee; Self; Sanofi-Aventis Deutschland GmbH. S. Pscherer: Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. J. Seufert: Speaker's Bureau; Self; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Boehringer Ingelheim GmbH, GI Dynamics Inc.. Research Support; Self; GI Dynamics Inc., GlaxoSmithKline plc., Intarcia Therapeutics, Inc., Ipsen Biopharmaceuticals, Inc., Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novartis Pharmaceuticals Corporation. Research Support; Self; Novartis Pharmaceuticals Corporation. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi-Aventis Deutschland GmbH. Research Support; Self; Sanofi-Aventis Deutschland GmbH. Advisory Panel; Self; Sanofi. Research Support; Self; Ypsomed AG.

Insulin Glargine 100 Units/mL Alone or in Combination with Short-Acting Insulin in the Management of Uncontrolled Type 2 Diabetes Mellitus: A Prospective Real-Life Study from Egypt (DIAMOND)

Abstract Background: Recent reports reveal growing evidence of the effectiveness of insulin glargine (Lantus®), a long-acting human insulin analogue, in the management of poorly con-trolled type 2 diabetes mellitus (T2DM). In the present real-life study.Aim of the Study: To investigate the safety and efficacy of insulin glargine in treating patients with T2DM that are poorly controlled on oral anti-diabetic drugs (OADs).Subjects and Methods: In this prospective observational study conducted in Egypt from 2014 to 2016, a total of 1008 people with poorly controlled T2DM were enrolled, and for whom the investigator decided to prescribe insulin glargine with or without short-acting insulin. The decision of adding-on OADs or short-acting insulin was left to the investigators to reflect the in-practice approach. Patients were followed up for six months and efficacy and safety outcomes were measured throughout the study period. The primary efficacy endpoint was the change in HbA1c levels from the baseline to the final visit. Results: At the end of follow-up, the mean HbA1c levels decreased significantly from 9.6±1.3% at the baseline to 7.3±0.9% (p 0.05). A total of 17 hypoglycemia events (11 categorized as serious) and one hyperglycemic event were recorded.Conclusion: Under real-world clinical practice insulin glargine 100U/ml as add-on to OADs, or in combination with prandial insulin, demonstrated a good efficacy and safety profile in people with T2DM uncontrolled previous on OAD therapy.

Glycaemic responses in Asian and non-Asian people with type 2 diabetes initiating insulin glargine 100 units/mL: A patient-level pooled analysis of 16 randomised controlled trials

AimsTo compare outcomes between Asian and non-Asian patients with type 2 diabetes (T2D) inadequately controlled on oral antidiabetic drugs (OADs) initiating insulin glargine 100 units (U)/mL (Gla-100) in randomised controlled clinical trials. MethodsPost hoc analysis of patient-level data (Asian n = 235; non-Asian n = 3351) from 16 trials. ResultsAt baseline, Asian patients were younger with lower body mass index (BMI), fasting C-peptide, and fasting plasma glucose (FPG) than non-Asian patients (all P < .001). Asian patients had a higher mean glycosylated haemoglobin (HbA1c) at Week 24 and less reduction in HbA1c from baseline (7.4% vs. 7.2%; −1.3% vs. −1.6%, respectively; P = .0001), and were less likely to achieve HbA1c <7.0% (40% vs. 47%; P = .002) than non-Asian patients. Reductions in FPG and rates of hypoglycaemia were similar between Asian and non-Asian patients. Asian patients had less weight gain than non-Asian patients (+1.3 vs. +1.9 kg, respectively, P = .013). ConclusionsIn our post hoc meta-analysis, Gla-100 effectively lowers HbA1c and FPG in Asian patients with T2D uncontrolled on OADs with similar incidence of hypoglycaemia and less absolute weight gain compared with non-Asian patients. At a similar FPG reduction, fewer Asian patients achieved HbA1c target <7.0%, suggesting that prandial glucose needs to be addressed.

The efficacy and safety of insulin degludec versus insulin glargine in insulin-naive subjects with type 2 diabetes: results of a Chinese cohort from a multinational randomized controlled trial

Objective: To compare the safety and efficacy of insulin degludec (IDeg) with those of insulin glargine (IGlar) in insulin-naive subjects with type 2 diabetes (T2DM). Methods: This was a 26-week, randomized, open-label, parallel-group, treat-to-target trial in 560 Chinese subjects with T2DM (men/women: 274/263, mean age 56 years, mean diabetes duration 7 years) inadequately controlled on oral antidiabetic drugs (OADs). Subjects were randomized 2∶1 to once-daily IDeg (373 subjects) or IGlar(187 subjects), both in combination with metformin. The primary endpoint was changes from baseline in glycosylated hemoglobin(HbA1c) after 26 weeks. Results: Mean HbA1c decreased from 8.2% in both groups to 6.9% in IDeg and 7.0% in IGlar, respectively. Estimated treatment difference (ETD) of IDeg-IGlar in change from baseline was -0.10% points (95%CI-0.25-0.05). The proportion of subjects achieving HbA1c<7.0% was 56.3%and 49.7% with IDeg and IGlar, respectively [estimated odds ratio of IDeg/IGlar: 1.26(95%CI 0.88-1.82)]. Numerically lower rateof overall confirmed hypoglycaemia and statistically significantly lower nocturnal confirmed hypoglycemia were associated with IDeg compared with IGlar, respectively [estimated rateratio of IDeg/IGlar 0.69(95%CI 0.46-1.03), and 0.43(95%CI 0.19-0.97)]. No differences in other safety parameters were found between the two groups. Conclusions: IDeg was non-inferior to IGlar in terms of glycaemic control, and was associated with a statistically significantly lower rate of nocturnal confirmed hypoglycaemia. IDeg is considered to be suitable for initiating insulin therapy in Chinese T2DM patients on OADs requiring intensified treatment. Clinical trail registration: Clinicaltrials.gov, NCT01849289.