CTRI/2022/10/046453RecruitingUnknown
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
Abbott Healthcare Pvt Ltd9 sites in 1 country210 target enrollmentStarted: October 24, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Abbott Healthcare Pvt Ltd
- Enrollment
- 210
- Locations
- 9
- Primary Endpoint
- Number and percentage of patients with adverse drug reactions (ADRs) and/or other pharmacovigilance- relevant information (OPRIs) from baseline to week 24
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
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:
- •Known case of type 1 Diabetes Mellitus (DM)
- •Known history of any acute metabolic diabetic complications such as ketoacidosis
- •Patients with known history of heart failure NYHA functional class IV
- •Patients with known history of hepatic impairment including patients with a pretreatment ALT or AST >2.5X the upper limit of normal
- •Patients with known history of moderate or severe renal impairment or End Stage Renal Disease (ESRD)
- •Patient with known hypersensitivity to Vildagliptin or to any of the excipients.
Outcomes
Primary Outcomes
Number and percentage of patients with adverse drug reactions (ADRs) and/or other pharmacovigilance- relevant information (OPRIs) from baseline to week 24
Time Frame: Baseline to week 24
Secondary Outcomes
- Change in HbA1c, FPG, LFT (AST and ALT), Serum Creatinine, Serum Amylase, Serum Lipase from baseline to week 24.(Baseline to week 24)
Investigators
Study Sites (9)
Loading locations...
Similar Trials
Terminated
Not Applicable
A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and NeckUnresectable Locally Advanced Squamous Cell Carcinoma of Head and NeckLA SCCHNNCT01303237Merck KGaA, Darmstadt, Germany88
Completed
Phase 4
Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean ChildrenHaemophilus Influenzae Type B InfectionNCT01404962Novartis Vaccines764
Completed
Unknown
A study to evaluate the safety and effect of Ropin Heavy® injection for spinal anaesthesia in adult subjectsAdministration,CTRI/2022/03/040917Neon Laboratories Ltd214
Terminated
Not Applicable
Linagliptin Among Filipino Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT01826370Boehringer Ingelheim678
Completed
Not Applicable
Barricaid EU Post Market Study for Primary Lumbar Disc HerniationLumbar Disc HerniationNCT01534065Intrinsic Therapeutics45