A Study to assess the safety of Vildagliptin Tablets 100 mg available in market.

Phase 4

Completed

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

• Registration Number: CTRI/2023/07/055146
• Lead Sponsor: Eris Lifesciences Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-04-06
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 205

Inclusion Criteria

1. Male or female patients aged 18 years and above.

2. Patients diagnosed with type 2 diabetes mellitus and who require treatment with Vildagliptin Sustained Release Tablets 100 mg as part of their routine treatment regimen.

3. Patient with ability to understand and provide written, signed and dated informed consent form.

Exclusion Criteria

1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.

2. Patients with a history of metabolic acidosis or diabetic ketoacidosis.

3. Patients with history of intolerance, contraindication or potential allergy/hypersensitivity to DPP-4 inhibitors.

4. Patients with history of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at baseline visit.

5. Patients with history of clinically significant impaired hepatic function at baseline visit.

6. Pregnant or breast-feeding or expecting to conceive within the projected duration of the study.

7. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods during the study.

8. Patients with history of congestive heart failure requiring pharmacologic management.

9. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients reporting incidences of AE and/or SAE during the study & their assessment in respect to intensity, duration, pattern & causal relationship to the study medication.Timepoint: Throughout the Study. <br/ ><br>At Visit 1 / Day 1, <br/ ><br>At Visit 2 (Week 12 / Day 84) and <br/ ><br>At Visit 3 (Week 24 / Day 168).

Secondary Outcome Measures

Name	Time	Method
Changes in clinical laboratory parameters from baseline to end of the study visit (week 24).Timepoint: At Visit 1 / Day 1, <br/ ><br>At Visit 2 (Week 12 / Day 84) and <br/ ><br>At Visit 3 (Week 24 / Day 168).;Mean change in 2-hr post prandial plasma glucose (2-hr PPG) from baseline to end of the study visit (week 24).Timepoint: At Visit 1 / Day 1, <br/ ><br>At Visit 2 (Week 12 / Day 84) and <br/ ><br>At Visit 3 (Week 24 / Day 168).;Mean change in fasting plasma glucose (FPG) from baseline to end of the study visit (week 24).Timepoint: At Visit 1 / Day 1, <br/ ><br>At Visit 2 (Week 12 / Day 84) and <br/ ><br>At Visit 3 (Week 24 / Day 168).;Mean change in glycosylated haemoglobin (HbA1c) from baseline to end of the study visit (week 24).Timepoint: At Visit 1 / Day 1, <br/ ><br>At Visit 2 (Week 12 / Day 84) and <br/ ><br>At Visit 3 (Week 24 / Day 168).