A Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Participants With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Monotherapy (MK-8835-012)

Summary

This is a study to evaluate the efficacy and safety of the addition of ertugliflozin to metformin monotherapy in Asian participants with Type 2 diabetes mellitis (T2DM) who have inadequate glycemic control on metformin monotherapy. The primary hypothesis is that the mean reduction from baseline in HbA1C for 15 mg and 5 mg ertugliflozin (tested sequentially) is greater than for placebo.

Timeline

Start

2015-12-16

Primary completion

2017-12-27

Completion

2017-12-27

Outcome

Met primary endpoint

registry analysis (superiority test); Ertugliflozin 15 mg vs Placebo; p <0.001; Difference in the LSM vs. placebo -0.69 (95% CI -0.85 to -0.52); cLDA NCT02630706 ↗

registry analysis (superiority test); Ertugliflozin 5 mg vs Placebo; p <0.001; Difference in the LS Means vs. Placebo -0.80 (95% CI -0.97 to -0.63); cLDA NCT02630706 ↗

paper At week 26, least squares mean (95% CI) change from baseline HbA1c was significantly greater with ertugliflozin 5- and 15 mg versus placebo PMID 30830724 ↗

Publications

• Ji L, Liu J, Xu ZJ, Wei Z, Zhang R, Malkani S, Cater NB, Frederich R. Efficacy and Safety of Ertugliflozin Added to Metformin: A Pooled Population from Asia with Type 2 Diabetes and Overweight or Obesity. Diabetes Ther. 2023 Feb;14(2):319-334. doi: 10.1007/s13300-022-01345-6. Epub 2023 Feb 3.
• Xu H, O'Gorman MT, Nepal S, James LP, Ginman K, Pithavala YK. Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1395-1404. doi: 10.1002/cpdd.1000. Epub 2021 Jul 20.
• 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.
• Ji L, Liu Y, Miao H, Xie Y, Yang M, Wang W, Mu Y, Yan P, Pan S, Lauring B, Liu S, Huyck S, Qiu Y, Terra SG. Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia. Diabetes Obes Metab. 2019 Jun;21(6):1474-1482. doi: 10.1111/dom.13681. Epub 2019 Apr 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ertugliflozin	Unknown	5 mg	Oral
Subject	Ertugliflozin	Unknown	15 mg	Oral
Background	Glimepiride	Small molecule	—	—
Background	Metformin	Small molecule	—	Oral

Indications