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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00778622

CV138-097

Details and patient eligibility

About

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

Enrollment: 371 patients

Sex: All

Ages: 17 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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371 participants in 3 patient groups

A1

Experimental group

Description:

Normal Weight by Body Weight Index

Treatment:

Drug: Metformin XR

A2

Experimental group

Description:

Overweight by Body Weight Index

Treatment:

Drug: Metformin XR

A3

Experimental group

Description:

Obese by Body Weight Index

Treatment:

Drug: Metformin XR