drugset / Trial / NCT00751114
Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: * HbA1c level * Fasting Plasma Glucose (FPG) * 7-point plasma glucose (PG) profiles * Percentage of patients with HbA1c \<7% and \<6.5% Safety objectives consisted of: * Hypoglycemia occurrence * Body weight * Overall safety
Timeline
- Start
- 2008-11
- Primary completion
- 2011-07
- Completion
- 2011-07
Publications
- Results Aschner P, Chan J, Owens DR, Picard S, Wang E, Dain MP, Pilorget V, Echtay A, Fonseca V; EASIE investigators. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. Lancet. 2012 Jun 16;379(9833):2262-9. doi: 10.1016/S0140-6736(12)60439-5. Epub 2012 Jun 9.
- Chan JC, Aschner P, Owens DR, Picard S, Vincent M, Dain MP, Pilorget V, Loizeau V, Echtay A, Fonseca V. Triple combination of insulin glargine, sitagliptin and metformin in type 2 diabetes: the EASIE post-hoc analysis and extension trial. J Diabetes Complications. 2015 Jan-Feb;29(1):134-41. doi: 10.1016/j.jdiacomp.2014.08.007. Epub 2014 Aug 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sitagliptin | Small molecule | 100 mg | Oral |
| Subject | insulin glargine | Protein / enzyme biologic | 0.2 iu/kg | Subcutaneous |
| Background | Metformin | Small molecule | — | Oral |