Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00778622
First received: October 22, 2008
Last updated: April 14, 2011
Last verified: April 2011
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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
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Metformin XR |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- HbA1c changes from baseline [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The relationship between Baseline BMI & FPG reduction [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- The relationship between Baseline HbA1c & its reduction [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- The relationship between baseline waist circumference/waist hip ratio and HbA1C reduction [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- The relative changes from Baseline in fasting lipids [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
| Enrollment: | 339 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A1
Normal Weight by Body Weight Index
|
Drug: Metformin XR
Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks
|
|
Experimental: A2
Overweight by Body Weight Index
|
Drug: Metformin XR
Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks
|
|
Experimental: A3
Obese by Body Weight Index
|
Drug: Metformin XR
Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks
|
Eligibility| Ages Eligible for Study: | 17 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- WOCBP
- BMI≥35 Kg/m2 or BMI <18.5 Kg/m2
- 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]
- ALT and/or 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778622
Locations
| China, Beijing | |
| Local Institution | |
| Beijing, Beijing, China, 100044 | |
| Local Institution | |
| Beijing, Beijing, China, 100034 | |
| Local Institution | |
| Beijing, Beijing, China, 100730 | |
| Local Institution | |
| Beijing, Beijing, China, 100028 | |
| Local Institution | |
| Beijing, Beijing, China, 101100 | |
| Local Institution | |
| Beijing, Beijing, China, 200016 | |
| Local Institution | |
| Beijing, Beijing, China, 100088 | |
| China, Guangdong | |
| Local Institution | |
| Guangdong, Guangdong, China, 510180 | |
| Local Institution | |
| Guangdong Province, Guangdong, China, 510180 | |
| Local Institution | |
| Guangdong Province, Guangdong, China, 528000 | |
| China, Shanghai | |
| Local Institution | |
| Shanghai, Shanghai, China, 200003 | |
| Local Institution | |
| Shanghai, Shanghai, China, 201100 | |
| Local Institution | |
| Shanghai, Shanghai, China, 201200 | |
| Local Institution | |
| Shanghai, Shanghai, China, 200092 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00778622 History of Changes |
| Other Study ID Numbers: | CV138-097 |
| Study First Received: | October 22, 2008 |
| Last Updated: | April 14, 2011 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013