Phase IV Study Evaluating the Effect of Sitagliptin (Januvia™) on Beta-cell Function in Patients With Acute Myocardial Infarction or Unstable Angina Pectoris and Newly Detected Impaired Glucose Tolerance or Type 2 Diabetes.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Improvement in beta-cell function measured by means of the insulinogenic index (ΔI30/ΔG30) obtained from an oral glucose tolerance test (OGTT)
研究概览
简要总结
A three months, double-blind, randomised, parallel-group study evaluating the efficacy of sitagliptin (Januvia™) versus placebo on beta-cell function in patients with newly detected glucose abnormalities and acute myocardial infarction or unstable angina pectoris.
Primary endpoint Improvement in beta-cell function measured by means of the insulinogenic index (ΔI30/ΔG30) obtained from an oral glucose tolerance test (OGTT).
Secondary endpoints
- Improvement of glucose tolerance by means of an OGTT
- Improvement in endothelial function
- Improvement in incretin-independent beta-cell function measured as the Acute Insulin Response (ΔAIRG) during an intravenous glucose tolerance test
详细描述
GENERAL AIM / PRIMARY OBJECTIVE The primary objective is to show that sitagliptin (Januvia™) 100 mg once daily for three months improves beta-cell function in patients with AMI or unstable angina pectoris and newly discovered glucose abnormalities (IGT or T2DM).
PRIMARY ENDPOINT The primary endpoint is improvement in beta-cell function after three months treatment measured by means of insulinogenic index (ΔI30/ΔG30) obtained from an oral glucose tolerance test (OGTT).
SECONDARY ENDPOINTS
- Improvement of glucose tolerance tested with an OGTT after three months.
- Improvement in endothelial function (measured with Endo-PAT2000, Itamar) after three months.
- Improvement in GLP-1 independent beta-cell function after three months measured as the ΔAIRG obtained from a "Frequently sampled intravenous glucose tolerance test" (FSIGT).
NUMBER OF PATIENTS PLANNED A total of 70-80 consecutive patients will be included with 35-40 patients in each treatment arm.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with an acute myocardial infarction or unstable angina pectoris according to the joint ESC and ACC recommendations [58].
- •Classification of impaired glucose tolerance (IGT) or type 2 diabetes (T2DM) by means of an oral glucose tolerance test (OGTT) according to WHO [59].
- •Patients who have signed a written informed consent consistent with ICH-GCP guidelines and local legislations prior to participation in the trial.
- •Exclusion criteria:
- •No informed consent.
- •<18 years old.
- •Previous known type 2 diabetes.
- •Admission plasma glucose >12 mmol/L.
- •Impaired renal function (S-creatinine ≥ 130 μmol/L or need of renal dialysis).
- •Known Type 1 diabetes, GAD positive or C-peptide<0.
- •Patients with severe concomitant disease (i.e. malignancy, liver failure).
- •Patients who at discharge are planned for Coronary Artery Bypass Grafting or percutaneous coronary intervention.
- •Congestive heart failure (NYHA III-IV).
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.
- •Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder, resident outside of the catchment area).
排除标准
- 未提供
研究组 & 干预措施
BE 1
Patients in this arm are randomly assigned to treatment with placebo
干预措施: Sitagliptin (Drug)
BE 2
Patients in this arm are randomly assigned to treatment with Sitagliptin
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Improvement in beta-cell function measured by means of the insulinogenic index (ΔI30/ΔG30) obtained from an oral glucose tolerance test (OGTT)
时间窗: By the end of the study as stated
次要结局
- Improvement in endothelial function(As stated for the study)
- Improvement of glucose tolerance by means of an OGTT(As stated for the study)
- Improvement in incretin-independent beta-cell function measured as the Acute Insulin Response (ΔAIRG) during an intravenous glucose tolerance test.(As stated for the study)
研究者
Lars Ryden
Professor
Karolinska Institutet