A clinical study to evaluate the efficacy and safety of Trelagliptin tablets (1 tablet in a week) in comparison to Vildagliptin tablets (daily 2 tablets) in patients with type 2 diabetes.

Phase 3

• Conditions: Health Condition 1: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2023/01/048826
• Lead Sponsor: Zuventus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Adults aged =18 years.

2. Naïve patients diagnosed with Type 2 diabetes mellitus.

3. Patients with glycosylated hemoglobin (HbA1c) ranged in 6.5-10% (both inclusive) at screening.

4. Patients with BMI ranged from 19-35 kg/m2 (both inclusive).

5. Patients who are willing to participate voluntarily and provide written informed consent

Exclusion Criteria

1. Patients with known hypersensitivity to Trelagliptin, Vildagliptin or any of the ingredients of the formulation.

2. History of acute or chronic liver disease, and SGOT or SGPT > 2.5 times of reference range or total bilirubin > 1.5 times of reference range during the screening period.

3. Renal insufficiency, with eGFR <60 ml/min/1.73 m2 or serum creatinine above 1.5 times of reference range at screening visit.

4. Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma), or severe chronic complications (proliferative diabetic retinopathy, diabetic nephropathy)

5. Active heart disease (including acute myocardial infarction, unstable angina), moderate to severe congestive heart failure

6. History of epilepsy, mental illness, major depression, or previous abnormal thyroid function and still being treated, or those with organ transplants, severe chronic lung disease, and other serious heart disease, cerebrovascular disease, blood disease.

7. Female patients who are pregnant, lactating or not following adequate contraceptive measures.

8. Patients otherwise judged to be inappropriate for inclusion in the study by the investigator.

9. Patients with known history of pancreatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified