NCT00778622
Completed
Phase 4
The Relationship Between Baseline Body Weight and Glycemic Control Following Metformin Extended-Release Tablets (Glucophage XR) Monotherapy in Chinese Patients With Newly Diagnosed Type 2 Diabetes
Overview
- Phase
- Phase 4
- Intervention
- Metformin XR
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 371
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Written Informed Consent
- •Age≥ 17 and \<80 years,
- •Newly diagnosed T2DM (defined as T2DM diagnosed within 6 months prior to enrollment)
- •Oral antidiabetic agents naïve (defined as without receiving any anti-diabetic medication therapy before, or having received anti-diabetic medication ≤ 14 days but not received any antidiabetic medication within the last 1 month prior to enrollment)
- •HbA1c ≥ 7.0% and ≤10.0%
Exclusion Criteria
- •Women of child bearing potential
- •body mass index (BMI)≥35 Kg/m2 or BMI \<18.5 Kg/m2
- •Hemoglobin A1c (HbA1c)\>10.0% or \<7.0%
- •Active liver disease and/or significant abnormal liver function
- •Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
- •Congestive heart failure defined as New York Heart Association (NYHA) class III or IV and /or left ventricular ejection fraction ≤40%
- •Significant cardiovascular history with the past 6 months
- •Severe retinopathy, persistent uncontrolled hypertension (SBP≥180mmHg, or DBP≥105mmHg)
- •Severe chronic gastrointestinal disease
- •History of alcohol abuse or illegal drug abuse within the past 12 months
Arms & Interventions
A1
Normal Weight by Body Weight Index
Intervention: Metformin XR
A2
Overweight by Body Weight Index
Intervention: Metformin XR
A3
Obese by Body Weight Index
Intervention: Metformin XR
Outcomes
Primary Outcomes
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)
Time Frame: Baseline to Week 16
Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit.
Secondary Outcomes
- Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set(Baseline to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set(Baseline to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set(Baseline to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set(Baseline to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set(Baseline to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set(Baseline to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set(Baseline to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set(Baseline to Week 16)
Study Sites (1)
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