A observational study to assess the effectiveness and safety of initial combination therapy with vildagliptin/metformin in drug-naïve Type II diabetes patients
- Conditions
- Health Condition 1: null- Type 2 diabetes mellitus
- Registration Number
- CTRI/2015/08/006079
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 765
1.Provide written informed consent before any data is collected
2. >18 years of age
3.Diagnosed with T2DM prior to study entry
4.At least one documented HbA1c >=7.5% measured within 4 weeks prior to study entry
5.Prescribed treatment with
vildagliptin/metformin initial dual therapy within 4 weeks of study entry and in compliance with the local prescribing information, i.e. vildagliptin/metformin dual therapy twice daily as either single pill combination or separate pill form
6.Are T2DM drug-naïve, defined as either patients who 1) have never received an antidiabetic medication, or 2) have not taken any antidiabetic medication in the last three months before study entry AND never for longer than three consecutive months, with the exception of the medication of interest described above
1.Contraindications to vildagliptin or metformin as per the local approved prescribing information
2.Use of any investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To assess the effectiveness of vildagliptin/metformin dual therapy as initial combination in drug-naïve adult type 2 diabetes patients over 24 weeksTimepoint: Over 24 weeks
- Secondary Outcome Measures
Name Time Method 1.To assess the proportion of patients achieving a glycemic target HbA1c level of 7% <br/ ><br>2.To assess the change from baseline in body weight over 24 weeks <br/ ><br>3.To assess overall safety and tolerability over 24 weeks <br/ ><br>4.To explore the change from baseline in HbA1c in relevant subpopulations (i.e. elderly, obese, patients with varying baseline HbA1c,) over 24 weeks <br/ ><br>Timepoint: Over 24 weeks