Study to evaluate safety of FDC of Evogliptin 5mg and Metformin hydrochloride IP (SR) 1000 mg film coated bilayered tablet available in market

Active post marketing surveillance of FDC of Evogliptin 5mg and Metformin hydrochloride IP (SR) 1000 mg film coated bilayered tablet

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/08/027111

Enrollment

300

Registered

2020-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: FDC of Evogliptin 5mg and Metformin hydrochloride IP (SR) 1000 mg film coated bilayered tablet: One Tablet to be taken once daily for 6 months Control Intervention1: Not Applicable: Not

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male/ Female Patients above 18 years of age. 2. Patients with type 2 diabetes mellitus, receiving FDC of Evogliptin 5mg + Metformin hydrochloride IP (SR) 1000 mg film coated bilayered tablet.

Exclusion criteria

Exclusion criteria: 1. Type I DM 2. Patients with history of hypersensitivity to DPP-IV inhibitors/ Evogliptin and or metformin 3. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study. 4. Pregnant or lactating female. 5. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study. 6. Patients with moderate (stage 3b) and severe renal disorders (CrCl 7. Patients with congestive heart failure requiring pharmacologic management

Design outcomes

Primary

Measure	Time frame
Number of AEs (adverse events) [Time Frame: Week 0-24] and Number of adverse reactions (ARs)Timepoint: Number of AEs (adverse events) [Time Frame: Week 0-24] and Number of adverse reactions (ARs)	—

Secondary

Measure	Time frame
Change in HbA1c (glycosylated hemoglobin), FBG (Fasting blood glucose) and PPG (Post prandial blood glucose)Timepoint: 24 weeks	—

Countries

India

Contacts

Public ContactDr Amol Aiwale

Alkem Laboratories Limited

abhijit.trailokya@alkem.com808004246

Outcome results

None listed

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