A observational study to assess the effectiveness and safety of initial combination therapy with vildagliptin/metformin in drug-naÃ¯ve Type II diabetes patients

A multinational, prospective, non-interventional 24-week study to assess effectiveness and safety of initial combination therapy with vildagliptin/metformin in drug-naÃ¯ve type 2 diabetes mellitus patients in a real life setting - INITIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2015/08/006079

Enrollment

765

Registered

2015-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 diabetes mellitus

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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-naÃ¯ve, 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1. To assess the effectiveness of vildagliptin/metformin dual therapy as initial combination in drug-naÃ¯ve adult type 2 diabetes patients over 24 weeksTimepoint: Over 24 weeks	—

Secondary

Measure	Time frame
1.To assess the proportion of patients achieving a glycemic target HbA1c level of 7% 2.To assess the change from baseline in body weight over 24 weeks 3.To assess overall safety and tolerability over 24 weeks 4.To explore the change from baseline in HbA1c in relevant subpopulations (i.e. elderly, obese, patients with varying baseline HbA1c,) over 24 weeks Timepoint: Over 24 weeks	—

Countries

Bangladesh, India, Other, Philippines, Singapore, Thailand

Contacts

Public ContactDr Smit Shah

Novartis Healthcare Private Limited

smit.shah@novartis.com02224958863

Outcome results