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Clinical Trials/CTRI/2012/11/003109
CTRI/2012/11/003109
Completed
Phase 4

A multicentre, prospective, observational cohort study to assess the effects of vildagliptin relative to sulphonylurea as dual therapy with metformin (or as monotherapy*) in Muslim patients with type 2 diabetes fasting during Ramadanâ?? - VIRTUE

ovartis HealthCare private Limited0 sites1,000 target enrollmentTBD
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ConditionsHealth Condition 1: null- Type 2 diabetic Patients during fasting in Ramadan

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Type 2 diabetic Patients during fasting in Ramadan
Sponsor
ovartis HealthCare private Limited
Enrollment
1000
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Pms

Investigators

Sponsor
ovartis HealthCare private Limited

Eligibility 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 \<\= 8\.5% (as measured within 6 weeks prior to entry into the study)

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.

Outcomes

Primary Outcomes

Not specified

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