drugset / Trial / NCT00775684
Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates exenatide, sitagliptin, and glimepiride for the treatment of high blood sugar in patients with impaired fasting glucose or early type 2 diabetes. The purpose of this study is to determine if exenatide and sitagliptin increase the amount of insulin made by the pancreas compared to glimepiride. It is hypothesized that exenatide or sitagliptin will sustain or increase the amount of insulin made by the pancreas in comparison to glimepiride.
Timeline
- Start
- 2008-10
- Primary completion
- 2012-11
- Completion
- 2012-11
Publications
- Background National Diabetes Statistics http://diabetes.niddk.nih.gov/dm/pubs/statistics/index.htm 2005. 2-16-2007 Ref Type: Electronic Citation
- Background King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. doi: 10.2337/diacare.21.9.1414.
- Background U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995 Nov;44(11):1249-58.
- Background Butler AE, Janson J, Bonner-Weir S, Ritzel R, Rizza RA, Butler PC. Beta-cell deficit and increased beta-cell apoptosis in humans with type 2 diabetes. Diabetes. 2003 Jan;52(1):102-10. doi: 10.2337/diabetes.52.1.102.
- Background Ritzel RA, Butler AE, Rizza RA, Veldhuis JD, Butler PC. Relationship between beta-cell mass and fasting blood glucose concentration in humans. Diabetes Care. 2006 Mar;29(3):717-8. doi: 10.2337/diacare.29.03.06.dc05-1538. No abstract available.
- Background Kahn SE. Clinical review 135: The importance of beta-cell failure in the development and progression of type 2 diabetes. J Clin Endocrinol Metab. 2001 Sep;86(9):4047-58. doi: 10.1210/jcem.86.9.7713. No abstract available.
- Background Godsland IF, Jeffs JAR, Johnston DG. Loss of beta cell function as fasting glucose increases in the non-diabetic range. Diabetologia. 2004 Jul;47(7):1157-1166. doi: 10.1007/s00125-004-1454-z. Epub 2004 Jul 13.
- Background Ward WK, Bolgiano DC, McKnight B, Halter JB, Porte D Jr. Diminished B cell secretory capacity in patients with noninsulin-dependent diabetes mellitus. J Clin Invest. 1984 Oct;74(4):1318-28. doi: 10.1172/JCI111542.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 10 ug | Subcutaneous |
| Comparator | Glimepiride | Small molecule | 0.5 mg | Oral |
| Subject | Sitagliptin | Small molecule | 100 mg | Oral |