Post Marketing Observational Study to Assess Safety and suitability of Vildagliptin 100mg SR formulation in Type 2 Diabetes Mellitus (T2DM) patients

Not Applicable

Recruiting

Brief Summary: 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 conducted on approximately on 210 patients from approximately 14 clinical sites. There are three visits in the study and study duration is of 168 days (24 weeks)+/- 2 week window period.

Recruitment & Eligibility

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 pretreatment 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.

Primary Outcome Measures

Name	Time	Method
Number and percentage of patients with adverse drug reactions (ADRs) and/or other pharmacovigilance- relevant information (OPRIs) from baseline to week 24	Baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c, FPG, LFT (AST and ALT), Serum Creatinine, Serum Amylase, Serum Lipase from baseline to week 24.	Baseline to week 24

Locations (9): Arthur Asirvatham Hospital
🇮🇳
Madurai, TAMIL NADU, India
Diabetes-Obesity-Thyroid and Hormone clinic
🇮🇳
Kolkata, WEST BENGAL, India
Excel Hospital
🇮🇳
Hyderabad, TELANGANA, India
Jindal Super Speciality Hospital
🇮🇳
Bharatpur, RAJASTHAN, India
Life Care Hospital
🇮🇳
Nashik, MAHARASHTRA, India
PCMCs PGI Yashwantrao Chavan Memorial Hospital
🇮🇳
Pune, MAHARASHTRA, India
PGIMER, Dept. of Endocrinology
🇮🇳
Chandigarh, CHANDIGARH, India
Sarthak Health Clinic
🇮🇳
Nashik, MAHARASHTRA, India
SMS Medical college and attached Hospital
🇮🇳
Jaipur, RAJASTHAN, India
Arthur Asirvatham Hospital
🇮🇳Madurai, TAMIL NADU, India
Dr Asirvatham A J
Principal investigator
9443751977
drajasirvatham@yahoo.co.in