drugset / Trial / NCT01006603
Saxagliptin Compared to Glimepiride in Elderly Type 2 Diabetes Patients, With Inadequate Glycemic Control on Metformin
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.
Timeline
- Start
- 2009-10
- Primary completion
- 2012-06
- Completion
- 2012-06
Outcome
Missed primary endpoint
paper Similar proportions of patients achieved the primary endpoint with saxagliptin and glimepiride (37.9 vs 38.2%; odds ratio 0.99, 95% confidence interval 0.73, 1.34; p = 0.9415) PMID 25761977 ↗
Publications
- Perl S, Cook W, Wei C, Ohman P, Hirshberg B. Effects of Glimepiride versus Saxagliptin on beta-Cell Function and Hypoglycemia: A Post Hoc Analysis in Older Patients with Type 2 Diabetes Inadequately Controlled with Metformin. Clin Ther. 2016 Dec;38(12):2578-2588. doi: 10.1016/j.clinthera.2016.10.006. Epub 2016 Nov 4.
- Schernthaner G, Duran-Garcia S, Hanefeld M, Langslet G, Niskanen L, Ostgren CJ, Malvolti E, Hardy E. Efficacy and tolerability of saxagliptin compared with glimepiride in elderly patients with type 2 diabetes: a randomized, controlled study (GENERATION). Diabetes Obes Metab. 2015 Jul;17(7):630-8. doi: 10.1111/dom.12461. Epub 2015 Apr 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glimepiride | Small molecule | 1 mg | Oral |
| Comparator | Glimepiride | Small molecule | 2 mg | Oral |
| Comparator | Glimepiride | Small molecule | 3 mg | Oral |
| Comparator | Glimepiride | Small molecule | 4 mg | Oral |
| Comparator | Glimepiride | Small molecule | 6 mg | Oral |
| Subject | SAXAGLIPTIN ANHYDROUS | Small molecule | 5 mg | Oral |