NCT00546325已完成3 期
REASURE: The Effect of Rimonabant on HbA1c in Overweight or Obese Patients With Type 2 Diabetes Not Adequately Controlled on 2 Oral Antidiabetic Agents
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Absolute change in HbA1c between both placebo and rimonabant group.
研究概览
简要总结
Primary:
To assess the effects of rimonabant on HbA1c in patients with Type 2 diabetes who are overweight or obese (Body Mass Index (BMI) > 27 kg/m² and BMI < 40 kg/m²), have uncontrolled HbA1c (7.0% - 9.0% inclusive) and are currently on maximal tolerated doses of two Oral Anti Diabetic medications - Metformin (Met) and Sulfonylurea (SU).
Secondary:
To assess the effects of rimonabant on Anthropometric measures, Glucose measures, Lipid measures, Other measures and changes in quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of Type 2 diabetes
- •HbA1c between 7% to 9% (inclusive)
- •BMI ≥ 27kg/m² and BMI ≤ 40kg/m²
- •Currently taking Metformin and Sulfonylurea.
排除标准
- •Uncontrolled serious psychiatric illness such as major depression
- •Current use of antidepressants
- •Severe renal impairment (creatinine clearance less than 30ml/min)
- •Severe hepatic impairment known by investigator or Aspartate Aminotransferase and/or Alanine Aminotransferase > 3 times Upper Limit Normal
- •Patient treated for epilepsy
- •Pregnant or breast-feeding women
- •Women of childbearing potential not protected by effective contraception
- •Hypersentivity/intolerance to rimonabant or any of the excipents
- •Presence of any condition, current or anticipated that in the investigator's opinion would compromise the patient's safety
- •Use of insulin for longer than 1 week within 4 weeks prior to screening
- •Chronic use of systemic corticosteriods
- •Use of glitazone therapy, glucagon-like peptide or dipeptidyl peptidase IV
- •History of drug or alcohol abuse wihtin the last three years
- •Heart failure class III-IV (New York Heart Association classification)
- •Severe hypertension
- •Adminstration of the following medications: phentermine, amphetamines, orlistat, sibutramine, herbal remedies
- •Use of non-lipid agents known to affect lipid metabolism: retinoids, antiretrovirals, hormone replacement therapy containing estrogens, cyclosporin, thiazolidinediones (glitazones), fish oils, plant sterols
- •Use of ketoconazole, itraconazole, ritonavir, clarithromycin, rifampicin, phenytoin, phenobarbitone, carbamazepine or St John's Wort
- •Participation in a clinical study within the 4 weeks prior to randomisation
- •Patients involved in an existing weight loss program
- •Presence of chronic hepatitis
- •Use, or misuse, of substances of abuse
- •Marijuana or hashish users
- •History of gastrointestinal surgery for weight loss purposes or who are scheduled for such surgery within the duration of their expected participation in this study
- •History or presence of bulimia or laxative abuse
- •Non-English speaking
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Rimonabant
干预措施: Rimonabant (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute change in HbA1c between both placebo and rimonabant group.
时间窗: From baseline to week 48
Percentage of participants reaching the treat-to-target objective of HbA1c ≤ 6.5% and ≤ 7.0%
时间窗: From the beginning to the end of the study
Percentage of participants responding to treatment
时间窗: From the beginning to the end of study
Rate of asymptomatic, symptomatic, and severe hypoglycaemia
时间窗: From the beginning to the end of the study
Change in physical examinations, vital signs, laboratory parameters, adverse events
时间窗: From the beginning to the end of the study
次要结局
- Change in insulin sensitivity, fasting plasma glucose, hypoglycaemia rate.(From the beginning to the end of the study)
- Change in lipid measures: HDL (High Density Lipoprotein), LDL (Low-Density Lipoprotein), TG (Triglycerides), TC (Total Cholesterol), ApoB (Apolipoprotein B)(From administration of drug till end of study)
- Change in BMI, waist and hip circumference, waist/hip ratio, weight(From the beginning to the end of the study)
- Changes in Quality of Life(From the beginning to the end of the study)
- Change in adiponectin, fasting insulin, Blood Pressure, concomitant medications, health resource use, CRP (C Reactive Protein), ALT (Alanine Aminotransferase), albumin/creatinine ratio(From administration of drug to end of study)
研究者
研究点 (1)
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