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The once-daily human glucagon-like peptide-1 analog, liraglutide, improves ?-cell function in Japanese patients with type 2 diabetes.

ABSTRACT: Aims/Introduction:? ?-cell function was evaluated by homeostasis model assessment of ?-cell function (HOMA-B) index, proinsulin:insulin and proinsulin:C-peptide ratios in adult, Japanese type?2 diabetes patients receiving liraglutide.? Data from two randomized, controlled clinical trials (A and B) including 664 Japanese type?2 diabetes patients (mean values: glycated hemoglobin [HbA1c] 8.61-9.32%; body mass index [BMI] 24.4-25.3?kg/m(2)) were analyzed. In two 24-week trials, patients received liraglutide 0.9?mg (n?=?268) or glibenclamide 2.5?mg (n?=?132; trial?A), or liraglutide 0.6, 0.9?mg (n?=?176) or placebo (n?=?88) added to previous sulfonylurea therapy (trial?B).? Liraglutide was associated with improved glycemic control vs sulfonylurea monotherapy or placebo. In liraglutide-treated groups in trials?A and B, area under the curve (AUC) insulin?0-3?h was improved (P?

SUBMITTER: Seino Y

PROVIDER: S-EPMC4019260 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature

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The once-daily human glucagon-like peptide-1 analog, liraglutide, improves β-cell function in Japanese patients with type 2 diabetes.

Seino Yutaka Y Rasmussen Mads Frederik MF Clauson Per P Kaku Kohei K

Journal of diabetes investigation 20120801 4

<h4>Unlabelled</h4>Aims/Introduction: β-cell function was evaluated by homeostasis model assessment of β-cell function (HOMA-B) index, proinsulin:insulin and proinsulin:C-peptide ratios in adult, Japanese type 2 diabetes patients receiving liraglutide.<h4>Materials and methods</h4> Data from two randomized, controlled clinical trials (A and B) including 664 Japanese type 2 diabetes patients (mean values: glycated hemoglobin [HbA1c] 8.61-9.32%; body mass index [BMI] 24.4-25.3 kg/m(2)) were anal ...[more]

PMID: 24843595

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Project description:ObjectiveHaving demonstrated short-term weight loss with liraglutide in this group of obese adults, we now evaluate safety/tolerability (primary outcome) and long-term efficacy for sustaining weight loss (secondary outcome) over 2 years.DesignA randomized, double-blind, placebo-controlled 20-week study with 2-year extension (sponsor unblinded at 20 weeks, participants/investigators at 1 year) in 19 European clinical research centers.SubjectsA total of 564 adults (n=90-98 per group; body mass index 30-40 kg m(-2)) enrolled, 398 entered the extension and 268 completed the 2-year trial. Participants received diet (500 kcal deficit per day) and exercise counseling during 2-week run-in, before being randomly assigned (with a telephone or web-based system) to once-daily subcutaneous liraglutide (1.2, 1.8, 2.4 or 3.0 mg, n=90-95), placebo (n=98) or open-label orlistat (120 mg × 3, n=95). After 1 year, liraglutide/placebo recipients switched to liraglutide 2.4 mg, then 3.0 mg (based on 20-week and 1-year results, respectively). The trial ran from January 2007-April 2009 and is registered with Clinicaltrials.gov, number NCT00480909.ResultsFrom randomization to year 1, liraglutide 3.0 mg recipients lost 5.8 kg (95% confidence interval 3.7-8.0) more weight than those on placebo and 3.8 kg (1.6-6.0) more than those on orlistat (P0.0001; intention-to-treat, last-observation-carried-forward). At year 2, participants on liraglutide 2.4/3.0 mg for the full 2 years (pooled group, n=184) lost 3.0 kg (1.3-4.7) more weight than those on orlistat (n=95; P<0.001). Completers on liraglutide 2.4/3.0 mg (n=92) maintained a 2-year weight loss of 7.8 kg from screening. With liraglutide 3.0 mg, 20-week body fat decreased by 15.4% and lean tissue by 2.0%. The most frequent drug-related side effects were mild to moderate, transient nausea and vomiting. With liraglutide 2.4/3.0 mg, the 2-year prevalence of prediabetes and metabolic syndrome decreased by 52 and 59%, with improvements in blood pressure and lipids.ConclusionLiraglutide is well tolerated, sustains weight loss over 2 years and improves cardiovascular risk factors.

Dataset Information

The once-daily human glucagon-like peptide-1 analog, liraglutide, improves ?-cell function in Japanese patients with type 2 diabetes.

Publications

The once-daily human glucagon-like peptide-1 analog, liraglutide, improves β-cell function in Japanese patients with type 2 diabetes.

Similar Datasets

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