Health Condition 1: null- Type 2 diabetic Patients during fasting in Ramadan
Conditions
Interventions
Control Intervention1: Vildagliptin Vs Sulphonylurea (Glimepiride): Vildagliptin (50mg BD) as dual therapy with metformin (500 -1500mg Daily) (or vildagliptin as monotherapy (50mg BD), or
Sulphonylu
Sponsors
Novartis HealthCare private Limited
Eligibility
Inclusion criteria
Inclusion criteria: The study includes patients who meet the following criteria: 1. Give written informed consent before any data is collected 2. 18 years of age or older 3. Diagnosed with T2DM at least 12 months prior to the start of Ramadan fasting 4. Treated, for at least 4 weeks but not more than 3 years before fasting commences, with either vildagliptin as dual therapy with metformin (or vildagliptin as monotherapy) OR sulphonylurea as dual therapy with metformin (or sulphonylurea as monotherapy) 5. Plan to fast during Ramadan 6. Have HbA1c
Exclusion criteria
Exclusion criteria: 1. Contraindications appearing in the local approved prescribing information for the prescribed medication 2. Use of any investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer 3. Patients who require three or more oral anti-diabetes therapies at time of study entry 4. Patients who are using insulin at the time of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Hypoglycaemic events â?¢ Weight â?¢ HbA1c â?¢ Treatment adherence Timepoint: Two data collection timepoints are required: â?¢ Baseline data collection opportunity 1 (Beginning of Ramadan) (DCO1): â?¢ Data collection opportunity 2 (DCO2): End of Study (End of Ramadan) Total Study Duration : 4 - 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Adverse events and serious adverse eventsTimepoint: Ongoing | — |
Countries
Bangladesh, India, United Arab Emirates
Contacts
Public ContactDr Abhijit Shete
Novartis India Limited
Outcome results
None listed