Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)

Summary

MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either placebo, 1 of 3 doses of ertugliflozin \[1, 5, or 25 mg\], or the approved drug hydrochlorothiazide \[HCTZ\]). The primary hypothesis of the study was that ertugliflozin was superior to placebo on the change from baseline in average, 24-hour systolic blood pressure (SBP) on Day 28.

Timeline

Start

2010-05-17

Primary completion

2011-02-09

Completion

2011-02-25

Outcome

Met primary endpoint

registry Placebo vs Ertugliflozin 1 mg; p = 0.034; Difference in least squares means -2.97 (80% CI -5.05 to -0.89) NCT01096667 ↗

registry Placebo vs Ertugliflozin 5 mg; p = 0.010; Difference in least squares means -4.00 (80% CI -6.17 to -1.82) NCT01096667 ↗

registry Placebo vs Ertugliflozin 25 mg; p = 0.012; Difference in least squares means -3.69 (80% CI -5.78 to -1.60) NCT01096667 ↗

Publications

• Results Amin NB, Wang X, Mitchell JR, Lee DS, Nucci G, Rusnak JM. Blood pressure-lowering effect of the sodium glucose co-transporter-2 inhibitor ertugliflozin, assessed via ambulatory blood pressure monitoring in patients with type 2 diabetes and hypertension. Diabetes Obes Metab. 2015 Aug;17(8):805-8. doi: 10.1111/dom.12486. Epub 2015 Jun 17.
• 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	—
Subject	Ertugliflozin	Unknown	5 mg	—
Subject	Ertugliflozin	Unknown	25 mg	—
Comparator	Hydrocholorthiazide	Unknown	12.5 mg	—

Indications