NCT00778622已完成4 期
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
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 371 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
A1
Experimental
Normal Weight by Body Weight Index
干预措施: Metformin XR (Drug)
A2
Experimental
Overweight by Body Weight Index
干预措施: Metformin XR (Drug)
A3
Experimental
Obese by Body Weight Index
干预措施: Metformin XR (Drug)
结局指标
主要结局
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)
时间窗: Baseline to Week 16
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.
次要结局
- Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set(Baseline to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set(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 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 to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set(Baseline to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set(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 to Week 16)
- Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set(Baseline to Week 16)
研究者
研究点 (1)
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