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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/10/046453

Enrollment

210

Registered

2022-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Vildagliptin 100 mg SR Formulation: Vildagliptin 100mg SR formulation in Type 2 Diabetes Mellitus (T2DM) patients Intervention2: Vildagliptin: Tab. Vildagliptin 100 mg SR Formulation on

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Number and percentage of patients with adverse drug reactions (ADRs) and/or other pharmacovigilance- relevant information (OPRIs) from baseline to week 24Timepoint: Baseline to week 24	—

Secondary

Measure	Time frame
Change in HbA1c, FPG, LFT (AST and ALT), Serum Creatinine, Serum Amylase, Serum Lipase from baseline to week 24.Timepoint: Baseline to week 24	—

Countries

India

Contacts

Public ContactDr Shivani Acharya

Abbott Healthcare Private Limited

ashwini.pawar@abbott.com8454041733

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026