VIRTUE - Study of Anti diabetes medicines during RAMADA
- Conditions
- Health Condition 1: null- Type 2 diabetic Patients during fasting in Ramadan
- Registration Number
- CTRI/2012/11/003109
- Lead Sponsor
- ovartis HealthCare private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1000
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 <= 8.5% (as measured within 6 weeks prior to entry into the study)
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Hypoglycaemic events <br/ ><br>â?¢Weight <br/ ><br>â?¢HbA1c <br/ ><br>â?¢Treatment adherence <br/ ><br>Timepoint: Two data collection timepoints are required: â?¢Baseline data collection opportunity 1 (Beginning of Ramadan) <br/ ><br>(DCO1): â?¢Data collection opportunity 2 (DCO2): End of Study (End of Ramadan) <br/ ><br>Total Study Duration : 4 - 6 weeks
- Secondary Outcome Measures
Name Time Method â?¢Adverse events and serious adverse eventsTimepoint: Ongoing