EUCTR2007-003963-31-SE进行中（未招募）不适用
A three months, double-blind, randomized, parallell-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 - BEGAMI
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients diagnosed with an acute myocardial infarction or unstable angina pectoris according to the joint ESC and ACC recommendations [58].
- •2. Classification of impaired glucose tolerance (IGT) or type 2 diabetes (T2DM) by means of an oral glucose tolerance test (OGTT) according to WHO [59].
- •3. Patients who have signed a written informed consent consistent with ICH-GCP guidelines and local legislations prior to participation in the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. No informed consent.
- •2. Previous known type 2 diabetes.
- •3. Admission plasma glucose >12 mmol/L.
- •4. Impaired renal function (S-creatinine = 130 µmol/L or need of renal dialysis).
- •5. BMI>30.
- •6. Known Type 1 diabetes, GAD positive or C-peptide<0.30.
- •7. Patients with severe concomitant disease (i.e. malignancy, liver failure).
- •8. Patients who at discharge are planned for Coronary Artery Bypass Grafting or percutaneous coronary intervention.
- •9. Congestive heart failure (NYHA III-IV).
- •10. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.
- •11. 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).
- •12. Age<18 years
研究者
相似试验
进行中（未招募）
1 期
A three-month, double-blind, double dummy, parallel group, controlled study comparing the efficacy and safety between 12 µg twice daily of Formoterol-HFA and 12 µg twice daily of Formoterol-DPI (Foradil/Aerolizer) in children with persistent asthmaChildren Persistent AsthmaMedDRA version: 7.0Level: LowClassification code 10003553EUCTR2004-000755-41-CZChiesi Farmaceurtici S.p.A460
进行中（未招募）
不适用
A study to evaluate the effect and safety of linagliptin 5 mg administered in combination with empagliflozin 10 mg or 25 mg in patients with type 2 diabetes mellitus whose glucose levels have not been controlled after 16 weeks of treatment with empagliflozin 10 mg or 25 mg and metformin.EUCTR2012-002271-34-ESBoehringer Ingelheim España, S.A690
进行中（未招募）
不适用
A study to evaluate the effect and safety of linagliptin 5 mg administered in combination with empagliflozin 10 mg or 25 mg in patients with type 2 diabetes mellitus whose glucose levels have not been controlled after 16 weeks of treatment with empagliflozin 10 mg or 25 mg and metformin.Diabetes mellitus type 2MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2012-002271-34-ITBOEHRINGER ING.1,843
进行中（未招募）
不适用
A study to evaluate the effect and safety of linagliptin 5 mg administered in combination with empagliflozin 10 mg or 25 mg in patients with type 2 diabetes mellitus whose glucose levels have not been controlled after 16 weeks of treatment with empagliflozin 10 mg or 25 mg and metformin.Diabetes mellitus type 2 is the medical condition to be investiagtedMedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-002271-34-PTnilfarma, Lda.690
进行中（未招募）
不适用
A study to evaluate the effect and safety of linagliptin 5 mg administered in combination with empagliflozin 10 mg or 25 mg in patients with type 2 diabetes mellitus whose glucose levels have not been controlled after 16 weeks of treatment with empagliflozin 10 mg or 25 mg and metformin.Diabetes mellitus type 2 is the medical condition to be investiagtedMedDRA version: 16.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-002271-34-DEBoehringer Ingelheim Pharma GmbH & Co. KG690