Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM

Summary

The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning \[qAM\]) compared to placebo. A single-blind reference treatment of 2000 mg metformin immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID) will also be included.

Timeline

Start

2015-09

Primary completion

2016-09

Completion

2016-09

Outcome

Met primary endpoint

registry analysis (superiority test); 1200 mg Met DR qAM vs Placebo; p = 0.0214; LS Means -0.42 (95% CI -0.79 to -0.06); Mixed Models Analysis NCT02526524 ↗

paper Metformin DR 1200 and 1500 mg significantly reduced HbA1c (-0.49±0.13% and -0.62±0.12%, respectively, vs. PBO -0.06±0.13%; p<0.05) PMID 30252913 ↗

Publications

• Henry RR, Frias JP, Walsh B, Skare S, Hemming J, Burns C, Bicsak TA, Baron A, Fineman M. Improved glycemic control with minimal systemic metformin exposure: Effects of Metformin Delayed-Release (Metformin DR) targeting the lower bowel over 16 weeks in a randomized trial in subjects with type 2 diabetes. PLoS One. 2018 Sep 25;13(9):e0203946. doi: 10.1371/journal.pone.0203946. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	600 mg	—
Subject	Metformin	Small molecule	900 mg	—
Subject	Metformin	Small molecule	1000 mg	—
Subject	Metformin	Small molecule	1200 mg	—
Subject	Metformin	Small molecule	1500 mg	—

Indications