Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

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

Outcome

Met primary endpoint

paper Ertugliflozin (1-25 mg/day) produced significant reductions in HbA1c concentration [placebo-corrected least-squares mean (LSM) -0.45% (1 mg) to -0.72% (25 mg); p ≤ 0.002 PMID 25754396 ↗

registry Placebo vs Ertugliflozin 1 mg; p = 0.002; Difference in least squares means -0.45 (80% CI -0.65 to -0.25) NCT01059825 ↗

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	—	—

Indications