Exploring the Substitution of Exenatide for Insulin in Patients With Type 2 Diabetes Treated With Insulin in Combination With Oral Antidiabetes Agents
- Stephen N. Davis, MD1,
- Don Johns, PHD2,
- David Maggs, MD3,
- Hangtao Xu, MS2,
- Justin H. Northrup, MPT2 and
- Robert G. Brodows, MD2
- 1Endocrinology and Metabolism, Vanderbilt University, Nashville, Tennessee
- 2Eli Lilly, Indianapolis, Indiana
- 3Amylin Pharmaceuticals, San Diego, California
- Address correspondence and reprint requests to Dr. Stephen N. Davis, Endocrinology and Metabolism, Vanderbilt University, 715 PRB, 2220 Pierce Ave., Nashville, TN 37232-6303. E-mail: steve.davis{at}vanderbilt.edu
Abstract
OBJECTIVE— This 16-week study explored the safety of substituting exenatide for insulin in patients with type 2 diabetes using insulin in combination with oral antidiabetes agents.
RESEARCH DESIGN AND METHODS— Successful maintenance of glycemic control was predefined as an A1C increase of <0.5%. A total of 49 patients (aged 53 ± 8 years, with BMI 34 ± 4 kg/m2, A1C 8.1 ± 1.1%, and duration of diabetes 11 ± 7 years) were randomized to either substitute exenatide for insulin or remain on their current insulin regimen. Patients who either completed ≥8 weeks of study or discontinued because of loss of glycemic control were included in primary efficacy analysis.
RESULTS— A total of 62% (18 of 29) of the exenatide-treated patients maintained glycemic control compared with 81% (13 of 16) of the insulin-treated patients. Of the 11 exenatide-treated patients who did not maintain control, 5 discontinued before week 16 because of loss of glucose control. The overall safety profile was generally consistent with previous exenatide trials. The mean overall hypoglycemia rates were 1.72 and 0.97 events/patient-year for the exenatide and insulin reference groups, respectively.
CONCLUSIONS— This pilot study suggests that it is feasible to sustain glycemic control when substituting exenatide for insulin. Although it is not possible to characterize clear predictors of outcome given the size and exploratory nature of the study, the data suggest that patients with longer disease duration, who are taking higher doses of insulin and have less endogenous β-cell function, may experience deterioration in glucose control if exenatide is substituted for insulin therapy.
Footnotes
-
Published ahead of print at http://care.diabetesjournals.org on 26 June 2007. DOI: 10.2337/dc06-2532. Clinical trial reg. no. NCT00099333, clinicaltrials.gov.
Additional information for this article can be viewed in an online appendix at http://dx.doi.org/10.2337/dc06-2532.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact.
See accompanying Editorial on p. 2972.
-
- Accepted June 19, 2007.
- Received December 14, 2006.
- DIABETES CARE
