drugset / Trial / NCT01059825
Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
RandomizedParallel-groupDouble-blindTreatment
Summary
MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.
Timeline
- Start
- 2010-02-24
- Primary completion
- 2011-01-20
- Completion
- 2011-01-20
Publications
- Results Amin NB, Wang X, Jain SM, Lee DS, Nucci G, Rusnak JM. Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. Diabetes Obes Metab. 2015 Jun;17(6):591-598. doi: 10.1111/dom.12460. Epub 2015 Mar 31.
- Fediuk DJ, Sahasrabudhe V, Dawra VK, Zhou S, Sweeney K. Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1297-1306. doi: 10.1002/cpdd.970. Epub 2021 Jul 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ertugliflozin | Unknown | 1 mg | Oral |
| Subject | Ertugliflozin | Unknown | 5 mg | Oral |
| Subject | Ertugliflozin | Unknown | 10 mg | Oral |
| Subject | Ertugliflozin | Unknown | 25 mg | Oral |
| Comparator | Sitagliptin | Small molecule | 100 mg | Oral |
| Background | Metformin | Small molecule | — | — |