Journal
DIABETES OBESITY & METABOLISM
Volume 13, Issue 5, Pages 418-425Publisher
WILEY
DOI: 10.1111/j.1463-1326.2011.01366.x
Keywords
GLP-1; GLP-1 analogue; randomized trial; type 2 diabetes
Categories
Funding
- Sanofi-Aventis
- Baxter Pharmaceuticals
- Novo Nordisk
- Eli Lilly
- Amylin
- Bristol-Myers Squibb
- Astra-Zeneca
- Merck
- Pfizer
- Roche
- MannKind
- GlaxoSmithKline
- Takeda
- Daiichi Sankyo
- Forest
- Johnson Johnson
- Boehringer Ingelheim
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Methods: Placebo-controlled, double-blind study in 262 patients (mean age 57 +/- 12 years; BMI 33.9 +/- 4.1 kg/m2; and glycosylated haemoglobin A1c (A1c) 8.24 +/- 0.93%) receiving two OAMs. Patients were randomized to once-weekly subcutaneous injections of placebo or LY 0.5 mg for 4 weeks, then 1.0 mg for 12 weeks (LY 0.5/1.0); 1.0 mg for 16 weeks (LY 1.0/1.0); or 1.0 mg for 4 weeks, then 2.0 mg for 12 weeks (LY 1.0/2.0). Results: At week 16, A1c changes (least-squares mean +/- standard error) were -0.24 +/- 0.12, -1.38 +/- 0.12, -1.32 +/- 0.12 and -1.59 +/- 0.12%, in the placebo, LY 0.5/1.0, LY 1.0/1.0 and LY 1.0/2.0 arms, respectively (all p < 0.001 vs. placebo). Both fasting (p < 0.001) and postprandial (p < 0.05) blood glucose decreased significantly compared to placebo at all LY doses. Weight loss was dose dependent and ranged from -1.34 +/- 0.39 to -2.55 +/- 0.40 kg at 16 weeks (all p < 0.05 vs. placebo). At the highest LY dosage, the most common adverse events were nausea (13.8%), diarrhoea (13.8%) and abdominal distension (13.8%). Hypoglycaemia was uncommon overall (< 0.8 episodes/patient/30 days) but more common with LY than placebo through the initial 4 weeks (p < 0.05). No differences in cardiovascular events or blood pressure were shown between treatments. Conclusions: LY2189265, given to overweight/obese patients with type 2 diabetes for 16 weeks in combination with OAMs, was relatively well tolerated and significantly reduced A1c, blood glucose and body weight.
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