drugset / Trial / NCT02607410
Sitagliptin (DPP-4 Inhibitor) and NPH Insulin in Patients With T2D
Phase 4
Completed
40 enrolled
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To compare the short and long term effects of inhibitor of the DPP-IV enzyme, sitagliptin , with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus biguanide: effects on beta cell function and on metabolic profile.
Timeline
- Start
- 2010-01
- Primary completion
- 2012-01
- Completion
- 2014-07
Publications
- Background Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8.
- Background Aulinger BA, Bedorf A, Kutscherauer G, de Heer J, Holst JJ, Goke B, Schirra J. Defining the role of GLP-1 in the enteroinsulinar axis in type 2 diabetes using DPP-4 inhibition and GLP-1 receptor blockade. Diabetes. 2014 Mar;63(3):1079-92. doi: 10.2337/db13-1455. Epub 2013 Dec 2.
- Background Retnakaran R, Qi Y, Opsteen C, Vivero E, Zinman B. Initial short-term intensive insulin therapy as a strategy for evaluating the preservation of beta-cell function with oral antidiabetic medications: a pilot study with sitagliptin. Diabetes Obes Metab. 2010 Oct;12(10):909-15. doi: 10.1111/j.1463-1326.2010.01254.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin | Protein / enzyme biologic | — | — |
| Comparator | Sitagliptin | Small molecule | 100 mg | — |