One-Year Treatment With Exenatide Improves β-Cell Function, Compared With Insulin Glargine, in Metformin-Treated Type 2 Diabetic Patients

Author:

Bunck Mathijs C.1,Diamant Michaela1,Cornér Anja2,Eliasson Bjorn3,Malloy Jaret L.4,Shaginian Rimma M.5,Deng Wei4,Kendall David M.46,Taskinen Marja-Riitta2,Smith Ulf3,Yki-Järvinen Hannele2,Heine Robert J.17

Affiliation:

1. Department of Endocrinology, Diabetes Center, VU University Medical Center, Amsterdam, the Netherlands;

2. Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland;

3. Lundberg Laboratory for Diabetes Research, Sahlgrenska University Hospital, Göteborg, Sweden;

4. Amylin Pharmaceuticals, San Diego, California;

5. Eli Lilly and Company, Houten, the Netherlands;

6. International Diabetes Center, Minneapolis, Minnesota;

7. Eli Lilly and Company, Indianapolis, Indiana.

Abstract

OBJECTIVE Traditional blood glucose–lowering agents do not sustain adequate glycemic control in most type 2 diabetic patients. Preclinical studies with exenatide have suggested sustained improvements in β-cell function. We investigated the effects of 52 weeks of treatment with exenatide or insulin glargine followed by an off-drug period on hyperglycemic clamp–derived measures of β-cell function, glycemic control, and body weight. RESEARCH DESIGN AND METHODS Sixty-nine metformin-treated patients with type 2 diabetes were randomly assigned to exenatide (n = 36) or insulin glargine (n = 33). β-Cell function was measured during an arginine-stimulated hyperglycemic clamp at week 0, at week 52, and after a 4-week off-drug period. Additional end points included effects on glycemic control, body weight, and safety. RESULTS Treatment-induced change in combined glucose- and arginine-stimulated C-peptide secretion was 2.46-fold (95% CI 2.09–2.90, P < 0.0001) greater after a 52-week exenatide treatment compared with insulin glargine treatment. Both exenatide and insulin glargine reduced A1C similarly: −0.8 ± 0.1 and −0.7 ± 0.2%, respectively (P = 0.55). Exenatide reduced body weight compared with insulin glargine (difference −4.6 kg, P < 0.0001). β-Cell function measures returned to pretreatment values in both groups after a 4-week off-drug period. A1C and body weight rose to pretreatment values 12 weeks after discontinuation of either exenatide or insulin glargine therapy. CONCLUSIONS Exenatide significantly improves β-cell function during 1 year of treatment compared with titrated insulin glargine. After cessation of both exenatide and insulin glargine therapy, β-cell function and glycemic control returned to pretreatment values, suggesting that ongoing treatment is necessary to maintain the beneficial effects of either therapy.

Publisher

American Diabetes Association

Subject

Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine

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