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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00778622
First received: October 22, 2008
Last updated: August 19, 2013
Last verified: August 2013
Results First Received: June 14, 2013  
Study Type: Interventional
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Started November 2009, Completed March 2011 at Peking University People's Hospital. Participants diagnosed with Type 2 diabetes mellitus 6 months prior to enrollment; were oral antidiabetic agent naive (either having received no antidiabetic agents or received agents 14 days or less, or received none within a month of enrollment in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants had glycosated hemoglobin A1c (HbA1c) screening values greater than, equal to 7.0% and less than, equal to 10.0%. Participants were between the ages of 17 and 80 years of age and Chinese Asian. Screening visit was up to 7 days prior to Day 1 (treatment).

Reporting Groups
  Description
Glucophage XR in Normal Weight Participants Normal weight was defined as body mass index (BMI) greater than, equal to (>=)18.5 kilogram per meter squared (kg/m^2) and less than (<) 24 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks.
Glucophage XR in Overweight Participants Overweight was defined as body mass index (BMI) greater than, equal to (>=) 24 kg/m^2 and less than (<) 28 kg/m^2. Initial dose of Glucophage extended release (XR) on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks
Glucophage XR in Obese Participants Obese was defined as body mass index (BMI) greater than, equal to (>=) 28 kg/m^2. Initial dose of Glucophage extended release (XR)on Day 1 was 500 mg taken once daily orally with the evening meal. Drug was titrated up by increments of 500 mg each week to a maximum dose of 2000 mg at Week 4 and for the remaining treatment if the fasting plasma glucose (FPG) was greater than 7.0 mmol/L (126 mg/dL). If the FPG was more than 10.0 mmol/L (greater than 180 mg/dL) at Weeks 4, 8, or 12 and the values were confirmed at a repeated measurement, the participant was discontinued from the treatment. Participants were dosed for a total of 16 weeks

Participant Flow:   Overall Study
    Glucophage XR in Normal Weight Participants     Glucophage XR in Overweight Participants     Glucophage XR in Obese Participants  
STARTED     125     122     124  
COMPLETED     109     107     109  
NOT COMPLETED     16     15     15  
Adverse Event                 5                 4                 7  
Withdrawal by Subject                 4                 5                 5  
Lost to Follow-up                 3                 3                 2  
Protocol Violation                 0                 3                 0  
Lack of Efficacy                 2                 0                 0  
immigration                 1                 0                 0  
unspecified                 1                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline population consisted of: all participants enrolled into one of three body weight arms, normal, overweight or obese, based on body mass index at screening; and who were assigned to treatment with Glucophage XR. This population was used for analysis of demographics.

Reporting Groups
  Description
Glucophage XR in Normal Weight Participants Normal weight was defined as body mass index (BMI) greater than, equal to 18.5 kg/m^2 and < 24 kg/m^2 ). Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
Glucophage XR in Overweight Participants Overweight was defined as body mass index (BMI) greater than, equal to 24 kg/m^2 and less than 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
Glucophage XR in Obese Participants Obese was defined as body mass index (BMI) greater than, equal to 28 kg/m^2. Glucophage XR titrated from Day 1 to Week 4 in increments of 500 mg up to maximum dose of 2000 mg. Participants were dosed for a total of 16 weeks.
Total Total of all reporting groups

Baseline Measures
    Glucophage XR in Normal Weight Participants     Glucophage XR in Overweight Participants     Glucophage XR in Obese Participants     Total  
Number of Participants  
[units: participants]
  125     122     124     371  
Age  
[units: years]
Median ( Full Range )
  53.0  
  ( 28 to 77 )  
  51.0  
  ( 32 to 77 )  
  52.5  
  ( 23 to 74 )  
  52.0  
  ( 23 to 77 )  
Gender  
[units: participants]
       
Female     64     45     52     161  
Male     61     77     72     210  
Region of Enrollment  
[units: participants]
       
China     125     122     124     371  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set   [ Time Frame: Baseline to Week 16 ]

3.  Secondary:   Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set   [ Time Frame: Baseline to Week 16 ]

4.  Secondary:   Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set   [ Time Frame: Baseline to Week 16 ]

5.  Secondary:   Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set   [ Time Frame: Baseline to Week 16 ]

6.  Secondary:   Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set   [ Time Frame: Baseline to Week 16 ]

7.  Secondary:   Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set   [ Time Frame: Baseline to Week 16 ]

8.  Secondary:   Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set   [ Time Frame: Baseline to Week 16 ]

9.  Secondary:   Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set   [ Time Frame: Baseline to Week 16 ]

10.  Other Pre-specified:   Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population   [ Time Frame: Day 1 to Week 16 ]

11.  Other Pre-specified:   Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population   [ Time Frame: Baseline to Week 16 ]

12.  Other Pre-specified:   Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population   [ Time Frame: Baseline to Week 16 ]

13.  Other Pre-specified:   Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population   [ Time Frame: Baseline to Week 16 ]

14.  Other Pre-specified:   Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population   [ Time Frame: Baseline to Week 16 ]

15.  Other Pre-specified:   Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population   [ Time Frame: Baseline to Week 16 ]

16.  Other Pre-specified:   Number of Participants Who Had a Normal Electrocardiogram (ECG) at Baseline and an ECG at Week 16 (or Termination Visit) Which Was Considered to be Abnormal With Clinical Significance - Safety Population   [ Time Frame: Baseline to Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00778622     History of Changes
Other Study ID Numbers: CV138-097
Study First Received: October 22, 2008
Results First Received: June 14, 2013
Last Updated: August 19, 2013
Health Authority: China: Food and Drug Administration