Status:
COMPLETED
Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
17-79 years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
371 Patients enrolled
Trial Details
Trial ID
NCT00778622
Start Date
November 1 2009
End Date
March 1 2011
Last Update
August 23 2013
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Beijing, Beijing Municipality, China, 100028
2
Local Institution
Beijing, Beijing Municipality, China, 100034
3
Local Institution
Beijing, Beijing Municipality, China, 100044
4
Local Institution
Beijing, Beijing Municipality, China, 100088