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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-03-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

Normal Weight by Body Weight Index

Group Type EXPERIMENTAL

Metformin XR

Intervention Type DRUG

Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks

A2

Overweight by Body Weight Index

Group Type EXPERIMENTAL

Metformin XR

Intervention Type DRUG

Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks

A3

Obese by Body Weight Index

Group Type EXPERIMENTAL

Metformin XR

Intervention Type DRUG

Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks

Interventions

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Metformin XR

Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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