CTRI/2021/11/038226招募中4 期
A Phase-IV, Multi-centric, Open Label, Comparative Clinical Trial to Evaluate Safety, Tolerability and Efficacy of Oral Tablets of Fixed-dose Combination of Alogliptin & Metformin Hydrochloride vs Alogliptin in the treatment of type-2 Diabetic mellitus
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The primary objective of this phase-IV trial is to find out safety & tolerability of the product
研究概览
简要总结
The present study drug is oral tablet formulation, which is a fixed-dose combination of Metformin Hydrochloride 500/1000 mg & Alogliptin 12.5/12.5mg. This fixed-dose combination is designed to act in the treatment of Type-2 Diabetes mellitus, which is one of the most commonly faced complaints all around the world. This is a 180-day trial to test the safety and efficacy of fixed-dose combination
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with duly filled in ICFs [Informed Consent Forms] Patients with Type 2 Diabetes new or inadequately controlled (HbA1c>7-9 %) by diet alone , exercise or not responding to monotherapy.
排除标准
- •Type-1 diabetes mellitus Patients already on Insulin therapy Patients already on triple oral anti-diabetic drug therapy New York Heart Association Class III–IV heart failure; receiving alogliptin in a previous investigational study History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischaemic attack in the previous 3months Planning for Pregnancy or lactating women Patients known, or thought to be hypersensitivity to study drugs Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion Participation in other clinical trials the last three months and during study participation Patients with severe renal impairment, including those receiving dialysis.
- •Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
结局指标
主要结局
The primary objective of this phase-IV trial is to find out safety & tolerability of the product
时间窗: 180 days
次要结局
- The secondary objective of this phase-IV trial is to find out efficacy of the product(180 days)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT02000700Janssen Research & Development, LLC17
已完成
4 期
Minocycline Pharmacokinetics (ACUMIN)Bacterial InfectionNCT03369951National Institute of Allergy and Infectious Diseases (NIAID)58
已完成
1 期
Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837HealthyNCT00878618AstraZeneca36
尚未招募
1 期
A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120AGastroesophageal Reflux Disease (GERD)NCT06916130Addpharma Inc.48
已完成
1 期
A Phase 1 Bioequivalence Study of a Test Tablet Formulation of Ravidasvir With the Reference Tablet Formulation of Ravidasvir StudyBioequivalence StudyNCT03602300Drugs for Neglected Diseases37