A Phase-IV Clinical Trial of Oral Tablets of Fixed-dose Combination of Alogliptin & Metformin Hydrochloride vs Alogliptin in the treatment of type-2 Diabetic mellitus

Phase 4

Recruiting

• Conditions: Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

• Registration Number: CTRI/2021/11/038226
• Lead Sponsor: Indoco Remedies Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 IIIââ?¬â??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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this phase-IV trial is to find out safety & tolerability of the productTimepoint: 180 days

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this phase-IV trial is to find out efficacy of the productTimepoint: 180 days