Phase 4 N=371 Treatment

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

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00778622 ↗

Enrolled (actual)

371

Serious AEs

0.5%

Results posted

Aug 2013

Primary outcome: Primary: Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS) — -1.95; -1.79; -1.68 percentage of hemoglobin — p=0.0806

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Metformin XR (Drug)
Age: Pediatric, Adult, Older Adult · 17+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)	-1.95; -1.79; -1.68	0.0806
SECONDARY Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set	-1.979; -2.171; -2.141	0.4614
SECONDARY Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set	-0.388; -0.048; -0.144	0.0305 sig
SECONDARY Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set	-0.306; -0.143; -0.181	0.4508
SECONDARY Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set	0.056; 0.024; 0.032	0.1431
SECONDARY Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set	-0.172; 0.262; -0.041	0.0210 sig
SECONDARY Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set	-0.589; 3.144; 1.633	—
SECONDARY Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set	0.465; 1.177; -1.792	—
SECONDARY Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set	1.742; 1.102; 0.050	—

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

Eligibility Criteria

Inclusion Criteria

Signed Written Informed Consent
Age≥ 17 and 10.0% or 1.5 X ULN and/or total bilirubin > 2 X ULN
Hemoglobin <12g/dL [males], <11g/dL [females]
Allergies and Adverse Drug Reactions
Prohibited Treatments and/or Therapies
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Subjects decline to participate

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00778622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.