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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Metformin

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

• Diagnosed anemia

• Creatine kinase ≥3 X ULN

• Serum creatinine ≥1.5 mg/dL(133μmol/L) [males], ≥1.4 mg/dL(124 μmol/L)[females]

• Alanine amino transferase (ALT) and/or aspartate amino transferase (AST)> 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