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

Study Overview
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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

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Metformin XR


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br>Normal Weight by Body Weight Index | Drug: Metformin XR<br>* Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks<br>|
| Experimental: A2<br>Overweight by Body Weight Index | Drug: Metformin XR<br>* Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks<br>|
| Experimental: A3<br>Obese by Body Weight Index | Drug: Metformin XR<br>* Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS) | Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit. | Baseline to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set | Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories. | Baseline to Week 16 | 
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set | For fasting total cholesterol (TC), baseline is defined as Day 1 (first day of treatment). Total cholesterol was measured in millimoles per liter (mmol/L) and obtained through local laboratories. | Baseline to Week 16 | 
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set | Baseline was defined as values obtained on Day 1. Low-density lipoprotein cholesterol (LDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories. | Baseline to Week 16 | 
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set | Baseline was defined as value obtained on Day 1 (first day of treatment). High-density lipoprotein cholesterol (HDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories. | Baseline to Week 16 | 
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set | Baseline was defined as value obtained on Day 1 (first day of treatment). Triglycerides (TG) were measured in millimoles per liter (mmol/L)and values obtained through local laboratories. | Baseline to Week 16 | 
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set | Baseline was defined as value obtained on Day 1 (first day of treatment). C-Reactive Protein (CRP) was measured in milligrams/liter (mg/L) and values were obtained through a central laboratory; normal was less than 5.0 mg/L. | Baseline to Week 16 | 
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set | Baseline was defined as value obtained on Day 1 (first day of treatment). PAI-1 (activity) was measured in units/milliliter (U/mL)and values obtained through a central laboratory; normal was less than 25.00 U/mL. | Baseline to Week 16 | 
| Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set | Baseline was defined as value obtained on Day 1 (first day of treatment). Adiponectin was measured in milligrams/liter (mg/L) and values obtained through a central laboratory; normal range was 1.20 to 20.00 mg/L. | Baseline to Week 16 |