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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00778622
First received: October 22, 2008
Last updated: April 14, 2011
Last verified: April 2011
  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