Efficacy and safety of iGlarLixi versus IDegAsp by baseline β-cell function in Chinese people with type 2 diabetes: Exploratory analyses of the Soli-D study.

IntroductionThe efficacy and safety of insulin degludec/liraglutide (IDegLira) has been evaluated in the Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes (DUAL) phase 3 clinical trial program. In this post hoc analysis, we compared the efficacy and safety of IDegLira in the Indian subpopulation with the results from the global trial population of DUAL trials. The analysis includes participants uncontrolled on oral antidiabetic drugs (OADs) in DUAL I and DUAL IV and participants uncontrolled on basal insulin and OADs in DUAL II.MethodsThree phase 3 trials were included in the analysis: DUAL I extension (IDegLira vs. insulin degludec or liraglutide 1.8 mg in participants uncontrolled on metformin ± pioglitazone; 52 weeks; n = 1663), DUAL IV (IDegLira vs. placebo as an add-on to a regimen of sulfonylurea ± metformin; 26 weeks; n = 435) and DUAL II (IDegLira vs. insulin degludec in participants uncontrolled on basal insulin + OADs; 26 weeks; n = 398). There were 251, 64 and 64 participants, respectively, at the Indian sites.ResultsIn the Indian subpopulations, the reductions in glycated hemoglobin (HbA1c) with IDegLira were substantial [DUAL I: 1.96% (−21 mmol/mol); DUAL IV: −1.40% (−15 mmol/mol); DUAL II: −2.20% (−24 mmol/mol)] and significantly greater than those in the comparators in each trial. IDegLira was generally weight-neutral after the administration of OADs (−0.3 and +0.6 kg in DUAL I and DUAL IV) and resulted in weight loss after the administration of basal insulin (−2.1 kg in DUAL II). Hypoglycemia rates were 1.98, 1.08 and 0.37 events/patient-years of exposure (PYE) for IDegLira, insulin degludec and liraglutide in DUAL I, 4.06 and 0.36 events/PYE for IDegLira and placebo in DUAL IV and 1.16 and 0.83 events/PYE with IDegLira and insulin degludec in DUAL II.ConclusionsResults from the Indian subpopulations reflect those of the global study populations, supporting IDegLira as an effective and safe treatment option for people with type 2 diabetes inadequately controlled on OADs or basal insulin + OADs in the South Asian population.Trial RegistrationClinicalTrials.gov identifier, NCT01336023 (DUAL I), NCT01392573 (DUAL II), NCT01618162 (DUAL IV).FundingNovo Nordisk A/S, Bagsvaerd, Denmark.

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

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<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.

Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation (PREDICTIVE) is a multi-national, open-label, prospective, observational study assessing the safety and efficacy of insulin detemir in clinical practice. This post hoc subanalysis evaluates insulin-naïve patients on oral antidiabetic drugs (OADs) who were initiated on insulin detemir as basal therapy (+/- OADs). The European cohort of the PREDICTIVE study currently includes 20,531 patients (12,981 with type 2 diabetes) who were prescribed insulin detemir and followed up for 12, 26 or 52 weeks. Here, we report data from a subgroup of 2377 OAD-treated, insulin-naïve type 2 diabetes patients for a mean follow-up of 14.4 weeks. Patients were prescribed insulin detemir as basal therapy (+/- OADs) by their physician, as part of routine clinical care. Results were reported in comparison with baseline observations. One serious adverse drug reaction was reported, which was a major hypoglycaemic episode. Treatment with insulin detemir (+/- OADs) significantly reduced mean haemoglobin A(1c) (HbA(1c)) (-1.3%; p < 0.0001), fasting glucose (-3.7 mmol/l; p < 0.0001), and within-patient fasting glucose variability (-0.5 mmol/l; p < 0.0001). In the majority of patients (82%), these improvements in glycaemic control were achieved with once daily administration of insulin detemir. There was a small reduction in mean body weight (-0.7 kg; p < 0.0001), which was most apparent in patients with a higher body mass index (BMI) at baseline. A significant negative relationship between weight change and baseline BMI was observed (greater the BMI, greater the weight reduction). Multiple regression analysis showed that BMI and HbA(1c) at baseline, and change in HbA(1c), were all predictors for weight change (p < 0.0001 for all), with BMI being the strongest predictor. Patients with type 2 diabetes naïve to insulin can be effectively treated with once-daily insulin detemir (+/- OADs) to achieve improved glycaemic control with no adverse effect on weight and a low risk of hypoglycaemia. These short-term results are consistent with the findings of clinical trials.

To evaluate early glycaemic control (glycated haemoglobin [HbA1c] < 7.0% [<53.0 mmol/mol], fasting plasma glucose [FPG] ≤ 7.0 mmol/L or postprandial glucose [PPG] ≤ 10.0 mmol/L) with iGlarLixi versus insulin glargine 100 U/mL (Gla-100) in Asian people with suboptimally controlled type 2 diabetes (T2D) on oral antidiabetic drugs (OADs) in LixiLan-O-AP or basal insulin (BI) ± OADs in LixiLan-L-CN. This post hoc analysis evaluated changes from baseline to Week 12 in HbA1c, FPG and PPG, hypoglycaemia incidence and the rates of target HbA1c achievement at Weeks 8 and 12. Median time to glycaemic control (i.e., time to 50% achieving target HbA1c, FPG or PPG) was also assessed. At Week 12, mean HbA1c reductions were greater with iGlarLixi versus Gla-100 in LixiLan-O-AP (-1.6% vs. -1.1% [-17.0 vs. -12.0 mmol/mol]) and LixiLan-L-CN (-1.3% vs. -0.5% [-13.9 vs. -5.4 mmol/mol]). PPG reductions were greater with iGlarLixi, while FPG reductions and hypoglycaemia incidence were similar. At Weeks 8 and 12, more participants had achieved target HbA1c or PPG with iGlarLixi versus Gla-100 in both studies. Median time to achieve HbA1c and PPG targets was shorter with iGlarLixi versus Gla-100 in LixiLan-O-AP (85 vs. 126 days and 84 vs. 167 days) and LixiLan-L-CN (85 vs. 239 days and 85 days vs. not estimable); median time to achieve FPG target was similar in LixiLan-O-AP (57 vs. 57 days) and LixiLan-L-CN (29 vs. 30 days). In Asian people with T2D suboptimally controlled on OADs or BI, iGlarLixi provided comprehensive earlier glycaemic control than Gla-100.

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.

Objective:The aim of this subanalysis of the IMPROVE study was to evaluate the safety and effectiveness of initiating biphasic insulin aspart 30/70 (BIAsp 30) in type 2 diabetes patients uncontrolled on oral antidiabetic drugs (OADs).Methods:IMPROVE is a 26-week, open-label, non-randomised, international observational study in type 2 diabetes patients prescribed BIAsp 30 in routine clinical practice. The total cohort comprised 52 419 patients from various pre-study therapies. Here results from the subgroup of previously insulin-naïve patients are reported. Changes in glycated haemoglobin (HbA1c), fasting blood glucose (FBG), postprandial blood glucose (PPBG), weight, dose, proportion of patients achieving HbA1c < 7.0%, and rates of major and minor hypoglycaemic events were recorded. Treatment satisfaction was assessed using a validated questionnaire.Results:A total of 29 160 insulin-naïve patients were included; mean age 55.6 years, diabetes duration 7.3 years, baseline HbA1c 9.24%. Significant reductions were seen for HbA1c (−2.12%; p < 0.0001), FBG (−4.07 mmol/L; p < 0.0001) and PPBG after all meals (mean: −5.27 mmol/L; p < 0.0001); 39.2% of patients achieved HbA1c < 7.0% without hypoglycaemia. Better glycaemic control was seen in patients treated with BIAsp 30 twice-daily (BID) both at baseline and final visit, or BID at baseline and three-times daily at final visit, compared with other regimens. The rate of major hypoglycaemic events decreased significantly, while the rate of minor hypoglycaemic events increased. Better glycaemic control and a lower rate of minor hypoglycaemia were observed in patients using BIAsp 30 without OADs than with OADs. There was no clinically relevant change in weight (−0.07 kg; p < 0.0001). At final visit, 59.7% of patients were extremely/very satisfied with treatment, compared with 10.2% at baseline.Conclusions:This open-label, non-randomised, observational study demonstrated that initiating insulin therapy with BIAsp 30 significantly improved glycaemic control in insulin-naïve patients previously poorly controlled on OADs. The rate of major hypoglycaemia was reduced and treatment satisfaction increased after initiation of BIAsp 30. Furthermore, better glycaemic control was achieved with BIAsp 30 without OAD compared to with OAD.

To evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) in people with uncontrolled type 2 diabetes (T2D) switching from another basal insulin (BI). INITIATION was an interventional, single-arm, phase IV study conducted in China. In this post hoc subpopulation analysis, the efficacy and safety of switching to Gla-300 was investigated in individuals with uncontrolled T2D (HbA1c 7.5%-11.0% [58-97 mmol/mol]) with previous BI. The primary endpoint was HbA1c change at week 24. Other measures of glycaemia, hypoglycaemia, insulin dose and weight change were assessed. Three hundred and two participants switched to Gla-300 from another BI, including 232 from insulin glargine 100 U/mL (Gla-100) and 55 from insulin degludec (IDeg). At week 24, the mean ± standard error (SE) HbA1c change from baseline was -0.87% ± 0.06% (-9.5 ± 0.7 mmol/mol; p <0.001). Significant reductions in fasting plasma glucose (least-squares mean [LSM] change -1.13 mmol/L) and fasting self-measured blood glucose (LSM change -1.36 mmol/L) were also observed (both p <0.001). The mean daily BI dose increased from 18.86 U (0.27 U/kg) at baseline to 28.83 U (0.41 U/kg) at week 24. During the 24-week treatment period, the incidence of any hypoglycaemia was 43.8% for all hypoglycaemia and 15.1% for nocturnal hypoglycaemia; the incidence of severe hypoglycaemia was low (0.7%). Minimal body weight change was documented. Gla-300 improved glycaemic control with a relatively low hypoglycaemia risk and minimal weight gain in Chinese people with T2D uncontrolled on previous BI.

OBJECTIVE: To assess the efficacy and safety of a 1:1 fixed ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naïve Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs (OADs). &lt;p&gt; &lt;/p&gt; &lt;p&gt;RESEARCH DESIGN AND METHODS: In this phase 3, open-label, multicenter trial, 321 patients with HbA&lt;sub&gt;1c&lt;/sub&gt; ≥7.5 to ≤10.0% (58 to 86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA&lt;sub&gt;1c&lt;/sub&gt; at week 26. &lt;/p&gt; &lt;p&gt; &lt;/p&gt; &lt;p&gt;RESULTS: Change in HbA&lt;sub&gt;1c&lt;/sub&gt; from baseline to week 26 was significantly greater with iGlarLixi (−1.58% [−17.3 mmol/mol]) than with Lixi (−0.51% [−5.6 mmol/mol]), confirming the superiority of iGlarLixi; least squares [LS] mean difference −1.07% [−11.7 mmol/mol], &lt;i&gt;P &lt;/i&gt;&lt; 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA&lt;sub&gt;1c&lt;/sub&gt; &lt;7% (53 mmol/mol; 65.2% vs. 19.4%; &lt;i&gt;P &lt;/i&gt;&lt; 0.0001) and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference −2.29 mmol/L [−41.23 mg/dL], &lt;i&gt;P &lt;/i&gt;&lt; 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%); rates of treatment-emergent adverse events were similar.&lt;/p&gt; &lt;p&gt; &lt;/p&gt; &lt;p&gt;CONCLUSIONS: This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with type 2 diabetes inadequately controlled on OADs.&lt;/p&gt;

OBJECTIVE: To assess the efficacy and safety of a 1:1 fixed ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naïve Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs (OADs). &lt;p&gt; &lt;/p&gt; &lt;p&gt;RESEARCH DESIGN AND METHODS: In this phase 3, open-label, multicenter trial, 321 patients with HbA&lt;sub&gt;1c&lt;/sub&gt; ≥7.5 to ≤10.0% (58 to 86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA&lt;sub&gt;1c&lt;/sub&gt; at week 26. &lt;/p&gt; &lt;p&gt; &lt;/p&gt; &lt;p&gt;RESULTS: Change in HbA&lt;sub&gt;1c&lt;/sub&gt; from baseline to week 26 was significantly greater with iGlarLixi (−1.58% [−17.3 mmol/mol]) than with Lixi (−0.51% [−5.6 mmol/mol]), confirming the superiority of iGlarLixi; least squares [LS] mean difference −1.07% [−11.7 mmol/mol], &lt;i&gt;P &lt;/i&gt;&lt; 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA&lt;sub&gt;1c&lt;/sub&gt; &lt;7% (53 mmol/mol; 65.2% vs. 19.4%; &lt;i&gt;P &lt;/i&gt;&lt; 0.0001) and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference −2.29 mmol/L [−41.23 mg/dL], &lt;i&gt;P &lt;/i&gt;&lt; 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%); rates of treatment-emergent adverse events were similar.&lt;/p&gt; &lt;p&gt; &lt;/p&gt; &lt;p&gt;CONCLUSIONS: This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with type 2 diabetes inadequately controlled on OADs.&lt;/p&gt;

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.

OBJECTIVETo assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).RESEARCH DESIGN AND METHODSIn this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58–86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA1c at week 26.RESULTSChange in HbA1c from baseline to week 26 was significantly greater with iGlarLixi (−1.58% [−17.3 mmol/mol]) than with Lixi (−0.51% [−5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference −1.07% [−11.7 mmol/mol], P < 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA1c <7% (53 mmol/mol) (65.2% vs. 19.4%; P < 0.0001), and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference −2.29 mmol/L [−41.23 mg/dL], P < 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.CONCLUSIONSThis phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.

IntroductionTo lower the barrier for initiating insulin treatment and obtain adequate glycemic control in type 2 diabetes mellitus (T2DM), new basal insulin preparations with improved pharmacological properties and consequently a lower risk of hypoglycemia are needed. The objective of this trial was to confirm the efficacy and compare the safety of insulin degludec (IDeg) with insulin glargine (IGlar) in a multinational setting with two thirds of subjects enrolled in China.MethodsThis was a 26-week, randomized, open-label, parallel-group, treat-to-target, non-inferiority trial in 833 subjects with T2DM (48 % were female, mean age 56 years, diabetes duration 8 years), inadequately controlled on oral antidiabetic drugs (OADs). Subjects were randomized 2:1 to once-daily IDeg (555 subjects) or IGlar (278 subjects), both with metformin. The primary endpoint was the change from baseline in glycosylated hemoglobin (HbA1c) after 26 weeks.ResultsThe completion rate was high (IDeg 94.2 %; IGlar 91.4 %). Mean HbA1c decreased from 8.3 to 7.0 % in both groups. Estimated treatment difference (ETD) [95 % confidence interval (CI)] IDeg-IGlar in change from baseline was −0.05 % points [−0.18 to 0.08], confirming the non-inferiority of IDeg to IGlar. The proportion of subjects achieving HbA1c <7.0 % was 54.2 and 51.4 % with IDeg and IGlar, respectively (estimated odds ratio [95 % CI] IDeg/IGlar: 1.14 [0.84 to 1.54]). The mean decrease in fasting plasma glucose, self-measured plasma glucose profiles, and insulin dose were similar between groups. Numerically lower rates of overall (estimated rate ratio [95 % CI] IDeg/IGlar: 0.80 [0.59 to 1.10]) and nocturnal (0.77 [0.43 to 1.37]) confirmed hypoglycemia were observed with IDeg compared with IGlar. No treatment differences in other safety parameters were found. Subjects were more satisfied with the IDeg device compared with the IGlar device as reflected by the total Treatment Related Impact Measures-Diabetes Device score (ETD [95 % CI] IDeg-IGlar: 2.2 [0.2 to 4.3]).ConclusionIDeg provided adequate glycemic control non-inferior to IGlar and a tendency for a lower hypoglycemia rate. IDeg is considered suitable for initiating insulin therapy in T2DM patients on OADs requiring intensified treatment.Trial RegistrationClinicaltrials.gov NCT01849289.Electronic supplementary materialThe online version of this article (doi:10.1007/s40268-016-0134-z) contains supplementary material, which is available to authorized users.

Diabetes News.

INTRODUCTIONType 2 Diabetes Mellitus (T2DM) poses significant cardiovascular risks. Individuals with HIV face compounded risks due to accelerated aging, chronic inflammation and certain antiretroviral therapies (ART). Postmenopausal women have increased cardiovascular risk. However, data on women living with HIV (WWH) and T2DM in Malaysia is scarce. METHODOLOGYThis study examines gaps in the management of T2DM and cardiometabolic health among WWH undergoing routine HIV care in a tertiary hospital. We reviewed the electronic medical records of WWH with T2DM attending the Infectious Diseases (ID) Clinic at Universiti Malaya Medical Centre (UMMC) in 2023. We extracted HIV demographics, anthropometrics, latest HbA1c, fasting plasma glucose (FPG) and lipid levels, and defined targets for control as per the 6th Malaysian Clinical Practice Guidelines for T2DM. Gaps in care were defined as the proportion not achieving targets for control of metabolic parameters. RESULTSWe collected data from 33 WWH with T2DM, representing 17.8% of all WWH in ID UMMC. Their median age was 54 years (IQR 49, 61) and the median duration since HIV diagnosis was 19 years (IQR 14, 25). All were on ART, with 30 (90.9%) having suppressed viral loads. Menopause status was recorded in 57.6% (n=19), with 78.9% (n=15) being menopausal. Four (12.1%) were active smokers. For T2DM management, 26 (96.3%) were on oral antidiabetic drugs (OADs) and 1 (3.7%) was on insulin. The most used OADs were metformin (65.7%), followed by sulfonylurea (25.7%) and SGLT2i (2.9%). Overall, 60.6% (n = 33) met the HbA1c target of &lt;7% and 66.7% had an FPG within 4.4-7.0 mmol/L (n = 30/33). For lipids, 54.8% (n = 31/33) had triglycerides ≤1.7 mmol/L, 67.7% (n=31/33) HDL &gt;1.2 mmol/L, and 56.7% (n = 30/33) LDL ≤2.6 mmol/L. 72.7% were on statins. For BP, only one (0.03%) had readings within the target range. 36.4% were on an ACE inhibitor or angiotensin-receptor blocker. Only 33.4% had an ideal BMI. CONCLUSIONThere are significant gaps in managing T2D among WWH. Addressing these gaps requires interdisciplinary collaboration for integrated care solutions.