Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients
Overview[ - collapse ][ - ]
Purpose | 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 |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Metformin XR |
Phase | Phase 4 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00778622 |
First Received | October 22, 2008 |
Last Updated | August 19, 2013 |
Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | October 22, 2008 |
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Last Updated Date | August 19, 2013 |
Start Date | November 2009 |
Estimated Primary Completion Date | March 2011 |
Current Primary Outcome Measures | 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] [Designated as safety issue: No]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. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients |
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Official Title | 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 |
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 |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Metformin XR Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 371 |
Estimated Completion Date | March 2011 |
Estimated Primary Completion Date | March 2011 |
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 - 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 |
Gender | Both |
Ages | 17 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00778622 |
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Other Study ID Numbers | CV138-097 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | August 2013 |
Locations[ + expand ][ + ]
Local Institution | Beijing, Beijing, China, 100044 |
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Local Institution | Beijing, Beijing, China, 100034 |
Local Institution | Beijing, Beijing, China, 100730 |
Local Institution | Beijing, Beijing, China, 100088 |
Local Institution | Beijing, Beijing, China, 101100 |
Local Institution | Beijing, Beijing, China, 200016 |
Local Institution | Beijing, Beijing, China, 100028 |
Local Institution | Guangdong, Guangdong, China, 510180 |
Local Institution | Guangdong Province, Guangdong, China, 510180 |
Local Institution | Guangdong Province, Guangdong, China, 528000 |
Local Institution | Shanghai, Shanghai, China, 200003 |
Local Institution | Shanghai, Shanghai, China, 200092 |
Local Institution | Shanghai, Shanghai, China, 201200 |
Local Institution | Shanghai, Shanghai, China, 201100 |