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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/08/006079
• Date of registration: 06-08-2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Healthcare Private Limited
• Public title: A observational study to assess the effectiveness and safety of initial combination therapy with vildagliptin/metformin in drug-naïve Type II diabetes patients
• Scientific title: A multinational, prospective, non-interventional 24-week study to assess effectiveness and safety of initial combination therapy with vildagliptin/metformin in drug-naïve type 2 diabetes mellitus patients in a real life setting - INITIAL
• Date of first enrolment: 01-09-2015
• Target sample size: 765
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11943
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 4

Countries of recruitment

Bangladesh, India, Other, Philippines, Singapore, Thailand

Contacts

• Name: Dr Smit Shah
• Affiliation: Novartis Healthcare Private Limited

• Name: Dr Smit Shah
• Affiliation: Novartis Healthcare Private Limited

Key inclusion & exclusion 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-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


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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Type 2 diabetes mellitus

Primary Outcome(s)

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(s)

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

Secondary ID(s)

CLAF237A3421, Version 01 dated 08 July 2015

Source(s) of Monetary Support

Novartis Healthcare Private Limited,Medical Department, Sandoz House,5th Floor, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400 018. INDIA.

Ethics review

Status: Approved
Approval date: 01/08/2015
Contact:

Institutional Ethics committee of Arthur Asirvatham hospital

Status: Approved
Approval date: 05/08/2015
Contact:

Institutional Ethics committee of Kovai diabetes speciality centre and hospital

Status: Approved
Approval date: 24/08/2015
Contact:

Ethics Committee of BSES Municipal General hospital

Status: Approved
Approval date: 30/08/2015
Contact:

Institutional Ethics Committee of M.V. Hospital & Research Centre

Status: Approved
Approval date: 28/09/2015
Contact:

Bhaktivedanta Hospital Ethics Committee

Status: Approved
Approval date: 16/11/2015
Contact:

Institutional Ethics committee of Max Super Speciality Hospital

Status: Approved
Approval date: 16/11/2015
Contact:

Institutional Ethics Committee Yasodha Academy of Medical Education and Research

Status: Approved
Approval date: 19/11/2015
Contact:

Institutional Ethics Committee of Fortis Hospital

Status: Approved
Approval date: 19/11/2015
Contact:

Institutional Ethics Committee of Poona Medical Research Foundation

Status: Approved
Approval date: 23/12/2015
Contact:

Ethics Committee of Jehangir Clinical Development Centre Pvt. Ltd.

Status: Approved
Approval date: 24/12/2015
Contact:

Institutional Ethics Committee Ajanta Hospital and IVF Centre

Status: Approved
Approval date: 13/01/2016
Contact:

Ethics Committee of M S Ramaiah Medical College and Hospitals