CTRI/2022/10/046453
Recruiting
Phase 4
A Multicentric Active Post Marketing Surveillance Study to Evaluate the Safety and Tolerability of Vildagliptin 100mg SR formulation in Type 2 Diabetes Mellitus (T2DM) patients - NA
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Sponsor
- Abbott Healthcare Pvt Ltd
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The inclusion criteria are in accordance with the approved prescribing information and the subjects meeting all of the criteria will be included:
- •1\.Male and female patients above 18 years of age.
- •2\.Type 2 diabetes mellitus patients prescribed Vildagliptin 100mg SR once daily formulation by the treating physician as per the approved prescribing information and in accordance with the clinical practice.
- •3\.Patients willing to sign patient authorization form (PAF)
Exclusion Criteria
- •The exclusion criteria are in accordance with the approved prescribing information and
- •the subjects meeting any of the criteria will be excluded:
- •1\. Known case of type 1 Diabetes Mellitus (DM)
- •2\. Known history of any acute metabolic diabetic complications such as ketoacidosis
- •3\. Patients with known history of heart failure NYHA functional class IV
- •4\. Patients with known history of hepatic impairment including patients with a pre treatment ALT or AST \>2\.5X the upper limit of normal
- •5\. Patients with known history of moderate or severe renal impairment or End Stage
- •Renal Disease (ESRD)
- •6\. Patient with known hypersensitivity to Vildagliptin or to any of the excipients
Outcomes
Primary Outcomes
Not specified
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