Dataset Information

Efficacy and safety of lobeglitazone monotherapy in patients with type 2 diabetes mellitus over 24-weeks: a multicenter, randomized, double-blind, parallel-group, placebo controlled trial.

ABSTRACT:

Objective

The aim of this study was to assess the glucose-lowering and lipid-modifying effects, and safety profile of lobeglitazone, a novel peroxisome proliferator-activated receptor- ? agonist, compared to placebo as a monotherapy in patients with type 2 diabetes.

Research design and methods

In this 24-week, multicenter, randomized, double-blind, parallel-group, placebo controlled study, 173 patients were randomly assigned (a 2?1 ratio) to lobeglitazone 0.5 mg (n=115) or matching placebo (n=58) orally once daily. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to the end of treatment. The secondary endpoints included various glycemic parameters, lipid parameters and safety profile (ClinicalTrials.gov number NCT01001611).

Results

At 24 weeks, a significant reduction in HbA1c was observed with lobeglitazone versus placebo (-0.44% vs 0.16%, mean difference -0.6%, p<0.0001). The goal of HbA1c <7% was achieved significantly more in the lobeglitazone group compared to the placebo group (44% vs 12%, p<0.0001). Markers of insulin resistance were also improved in the lobeglitazone group. In addition, lobeglitazone treatment significantly improved triglycerides, high density lipoprotein cholesterol, small dense low density lipoprotein cholesterol, free fatty acid, and apolipoprotein-B/CIII compared to placebo (p<0.01, respectively). More weight gain was observed in the lobeglitazone group than the placebo group (0.89 kg vs - 0.63 kg, mean difference 1.52 kg, p<0.0001). The safety profile was comparable between the two groups and lobeglitazone was well tolerated.

Conclusions

Lobeglitazone 0.5 mg showed a favorable balance in the efficacy and safety profile. The results support a potential role of lobeglitazone in treating type 2 diabetes.

Trial registration

Clinicaltrials.gov NCT01001611.

SUBMITTER: Kim SG

PROVIDER: S-EPMC3988010 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of lobeglitazone monotherapy in patients with type 2 diabetes mellitus over 24-weeks: a multicenter, randomized, double-blind, parallel-group, placebo controlled trial.

Kim Sin Gon SG Kim Doo Man DM Woo Jeong-Taek JT Jang Hak Chul HC Chung Choon Hee CH Ko Kyung Soo KS Park Jeong Hyun JH Park Yong Soo YS Kim Sang Jin SJ Choi Dong Seop DS

PloS one 20140415 4

<h4>Objective</h4>The aim of this study was to assess the glucose-lowering and lipid-modifying effects, and safety profile of lobeglitazone, a novel peroxisome proliferator-activated receptor- γ agonist, compared to placebo as a monotherapy in patients with type 2 diabetes.<h4>Research design and methods</h4>In this 24-week, multicenter, randomized, double-blind, parallel-group, placebo controlled study, 173 patients were randomly assigned (a 2∶1 ratio) to lobeglitazone 0.5 mg (n=115) or matchin ...[more]

PMID: 24736628

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Project description:IntroductionMaintenance of drug efficacy and safety over the long term is important to investigate for progressive conditions like type 2 diabetes mellitus (T2DM). This study aimed to evaluate whether efficacy of dapagliflozin added to glimepiride observed at 24 weeks was maintained at 48 weeks, and to provide further safety and tolerability data in patients with T2DM.MethodsThis 24-week randomized, double-blind, parallel-group, placebo-controlled trial with a 24-week double-blind extension period enrolled adults whose T2DM was inadequately controlled [glycated hemoglobin (HbA1c) 7.0-10.0%] on sulfonylurea monotherapy. Patients were randomized to placebo (n = 146) or dapagliflozin 2.5 mg (n = 154), 5 mg (n = 145), or 10 mg (n = 151) per day added to open-label glimepiride 4 mg/day.ResultsIn total, 519 patients (87.1%) completed the study. At 48 weeks, HbA1c adjusted mean changes from baseline for the placebo versus dapagliflozin 2.5/5/10-mg groups were -0.04% versus -0.41%, -0.56% and -0.73%, respectively. There were no meaningful differences in HbA1c changes from baseline from 24 to 48 weeks, indicating that glycemic efficacy was maintained. Improvements in fasting plasma glucose and post-challenge plasma glucose were also observed with dapagliflozin over 48 weeks. Dapagliflozin 2.5/5/10 mg produced sustained reductions in weight (-1.36/-1.54/-2.41 kg) versus placebo (-0.77 kg). Adjusted mean reductions from baseline in systolic blood pressure were also greater than placebo for all dapagliflozin doses. In the placebo versus dapagliflozin groups, serious adverse events were 8.9% versus 8.6-11.0%, hypoglycemic events were 6.8% versus 9.7-11.3%, and events suggestive of genital infection were 1.4% versus 5.2-8.6%.ConclusionDapagliflozin added to glimepiride improved glycemic control and body weight, with short-term findings maintained during the study's extension period. Therapy was generally well tolerated over 48 weeks; hypoglycemic events and events suggestive of genital infection were reported more often in patients receiving dapagliflozin.

Project description:BackgroundDipeptidyl peptidase-4 inhibitors (DPP-4i) have become firmly established in treatment algorithms and national guidelines for improving glycemic control in type 2 diabetes mellitus (T2DM).To report the findings from a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, which was designed to assess the efficacy and safety of a novel DPP-4 inhibitor fotagliptin in treatment-naive patients with T2DM.MethodsPatients with T2DM were randomized to receive fotagliptin (n = 230), alogliptin (n = 113) or placebo (n = 115) at a 2:1:1 ratio for 24 weeks of double-blind treatment period, followed by an open-label treatment period, making up a total of 52 weeks. The primary efficacy endpoint was to determine the superiority of fotagliptin over placebo in the change of HbA1c from baseline to Week 24. All serious or significant adverse events were recorded.ResultsAfter 24 weeks, mean decreases in HbA1c from baseline were -0.70% for fotagliptin, -0.72% for alogliptin and -0.26% for placebo. Estimated mean treatment differences in HbA1c were -0.44% (95% confidence interval [CI]: -0.62% to -0.27%) for fotagliptin versus placebo, and -0.46% (95% CI: -0.67% to -0.26%) for alogliptin versus placebo, and 0.02% (95%CI: -0.16% to 0.19%; upper limit of 95%CI < margin of 0.4%) for fotagliptin versus alogliptin. So fotagliptin was non-inferior to alogliptin. Compared with subjects with placebo (15.5%), significantly more patients with fotagliptin (37.0%) and alogliptin (35.5%) achieved HbA1c < 7.0% after 24 weeks of treatment. During the whole 52 weeks of treatment, the overall incidence of hypoglycemia was low for both of the fotagliptin and alogliptin groups (1.0% each). No drug-related serious adverse events were observed in any treatment group.ConclusionsIn summary, the study demonstrated improvement in glycemic control and a favorable safety profile for fotagliptin in treatment-naive patients with T2DM.Trial registrationClinicalTrail.gov NCT05782192.

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Dataset Information

Efficacy and safety of lobeglitazone monotherapy in patients with type 2 diabetes mellitus over 24-weeks: a multicenter, randomized, double-blind, parallel-group, placebo controlled trial.

Objective

Research design and methods

Results

Conclusions

Trial registration

Publications

Efficacy and safety of lobeglitazone monotherapy in patients with type 2 diabetes mellitus over 24-weeks: a multicenter, randomized, double-blind, parallel-group, placebo controlled trial.

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