TITLE

Pramlintide Improved Glycemic Control and Reduced Body Weight in Patients With Type 2 Diabetes Treated With Basal Insulin (Without Mealtime Insulin) and a Thiazolidinedione

AUTHOR(S)
Lorenzi, Gayle; Frias, Juan; Lutz, Karen; Kesty, Nicole; Zhang, Bei; Kolterman, Orville
PUB. DATE
June 2007
SOURCE
Diabetes;Jun2007 Supplement 1, Vol. 56, pA147
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Pramlintide (PRAM), an analog of the β-cell hormone amylin, improves glycemic control and body weight in patients with type 2 diabetes (T2DM) treated with insulin with or without sulfonylurea (SFU) and/or metformin (MET). Its efficacy and safety as an adjunct to insulin+thiazolidinedione (TZD), a regimen olden resulting in weight gain, has not been reported. This post-hoc analysis of a 16-wk, randomized, placebo- (PBO) controlled trial in patients with T2DM (N=211) treated with basal insulin (insulin glargine) assessed the effects of PRAM (60 or 120 µg before major meals) in a subgroup (n=54) concomitantly treated with TZD with or without SFU and/or MET. Patients were randomized to PRAM (n=33; age 54±8 y; A1C 8.3±0.8%; wt 105.1±19.1 kg; basal insulin 50±20 U; mean±SD) or PBO (n=21; age 58±9 y; A1C 8.3±0.9%; wt 108.8±14.1 kg; basal insulin 38±24 U). Insulin was titrated weekly to a target FPG of 70-100 mg/dL (Wk-16 dose: PRAM 61±4 U; PBO 44±6 U; mean±SE). To achieve the composite endpoint, patients met all of the following at Wk 16:1) A1C ≤7% or reduction ≥0.5%; 2) Mean PPG excursion ≤40mg/dL; 3) No weight gain; 4) No severe hypoglycemia. The composite endpoint was achieved by 27% of PRAM- and 14% of PBO-treated patients. Both groups achieved significant reductions from baseline in A1C (both -0.6±0.2%; P<0.05) and FPG (PRAM -40.9±13.7; PBO -22.2±13.6 mg/dL; P<0.001). PRAM significantly reduced PPG excursions compared with PBO (-26.4±6.2 vs -7.5±7.6 mg/dL; P<0.05). Improvements in glycemia were accompanied by progressive weight loss with PRAM and weight gain with PBO (-1.7±0.5 kg vs +1.7±0.8 kg; P<0.001). Nausea, mostly mild/moderate, was reported by 36% of PRAM- and 10% of PBO-treated patients. The incidence of mild/moderate hypoglycemia was 46% and 67% for PRAM and PBO groups, respectively. There was no severe hypoglycemia. In patients with T2DM, PRAM as an adjunct to basal insulin+TZD improved glycemic control and led to significant reductions hi body weight.
ACCESSION #
25820864

 

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