Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients

Phase 4 Completed 371 enrolled Bristol-Myers Squibb

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate the effect of the baseline body mass index (BMI) on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with newly diagnosed type 2 diabetes

Timeline

Start: 2009-11
Primary completion: 2011-03
Completion: 2011-03

Outcome

Missed primary endpoint

paper Mean HbA1c decreases at week 16, adjusted for baseline values, were -1.84%, -1.78% and -1.78% in normal-weight, overweight and obese patients, (P = 0.664); PMID 23468941 ↗

registry Glucophage XR in Normal Weight Participants vs Glucophage XR in Overweight Participants vs Glucophage XR in Obese Participants; p = 0.0806; ANCOVA NCT00778622 ↗

Publications

Ji L, Li H, Guo X, Li Y, Hu R, Zhu Z. Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial. PLoS One. 2013;8(2):e57222. doi: 10.1371/journal.pone.0057222. Epub 2013 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	500 mg	Oral