A comparatative trial of two gliptins - linagliptin and vildagliptin - in diabetic patients

Phase 4

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

• Registration Number: CTRI/2024/06/068837
• Lead Sponsor: Dr. Harshad Venugopal Ramineni

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Case of type 2 diabetes mellitus (T2DM), and

2. On a stable dose of oral tablet metformin = 1000 mg/day and oral tablet glimepiride = 2 mg/day for at least 12 weeks, and

3. Inadequately controlled blood glucose as indicated by HbA1c: = 7.5% and = 11% in the past 2 weeks, and

4. Started on either oral tablet linagliptin 5 mg/day, or oral tablet vildagliptin 100 mg/day in the past 1 week, and

5. Giving written consent for participating in the study

Exclusion Criteria

1. Participants currently receiving insulin therapy for the management of T2DM, or

2. Participants currently receiving any other sulfonylureas (other than glimepiride), thiazolidinediones, sodium-glucose cotransporter-2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, or alpha-glucosidase inhibitors for the management of T2DM, or

3. Participants currently receiving beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers, or statins for cardiovascular management, or

4. Participants currently receiving prokinetic agents, such as metoclopramide, domperidone, trimebutine, cisapride, itopride, prucalopride and mosapride, or antacids containing aluminium or magnesium hydroxide, or

5. Participants with known allergies or sensitivities to linagliptin, vildagliptin, metformin or glimepiride, or

6. Pregnant or lactating individuals, or

7. Participants with a history of intolerance or adverse reactions to linagliptin, vildagliptin, or other dipeptidyl peptidase-4 (DPP-4) inhibitors, or

8. Participants with uncontrolled hepatic impairment (as indicated by elevated liver enzymes, i.e., AST or ALT, beyond three times the upper limit of laboratory reference range) or severe renal impairment (as indicated by creatinine clearance < 45 mL/min)

Study & Design

• Study Type: Interventional
• Study Design: Not specified