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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/038226

Enrollment

200

Registered

2021-11-24

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Fixed-dose Combination of Alogliptin & Metformin Hydrochloride: Metformin Hydrochloride 500/1000 mg & Alogliptin 12.5/12.5mg twice a day with food for 180 days Control Intervention1: Al

Eligibility

Inclusion criteria

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

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 IIIÃ¢â?¬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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactMr Rahul Hiware

INDOCO REMEDIES LIMITED

drsahoo@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026