CTRI/2021/11/038226RecruitingPhase 4
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
Indoco Remedies Limited4 sites in 1 country200 target enrollmentStarted: December 20, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Indoco Remedies Limited
- Enrollment
- 200
- Locations
- 4
- Primary Endpoint
- The primary objective of this phase-IV trial is to find out safety & tolerability of the product
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The primary objective of this phase-IV trial is to find out safety & tolerability of the product
Time Frame: 180 days
Secondary Outcomes
- The secondary objective of this phase-IV trial is to find out efficacy of the product(180 days)
Investigators
Study Sites (4)
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