An clinical trial to compare the combination and alone of 2 drugs, glimepiride and metformin in patients with type 2 diabetes

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2012/08/002846
• Date of registration: 01-08-2012
• Prospective Registration: No
• Primary sponsor: Sanofi Synthelabo I Ltd
• Public title: An clinical trial to compare the combination and alone of 2 drugs, glimepiride and metformin in patients with type 2 diabetes
• Scientific title: A multinational, open label, randomized, active-controlled, 3-arm parallel group, 24-week study comparing the combination of glimepiride and metformin versus glimepiride and metformin alone in patients with type 2 diabetes - RECOMMEND
• Date of first enrolment: 11-07-2012
• Target sample size: 1116
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4088
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

Algeria, Colombia, Egypt, Guatemala, India, Iran (Islamic Republic of), Kuwait, Lebanon, Mexico, Morocco, Russian Federation, Saudi Arabia, South Africa, Tunisia, Turkey, Ukraine, United Arab Emirates

Contacts

• Name: Salini JAMES
• Affiliation: Sanofi Synthelabo (I) Ltd

• Name: Salini JAMES
• Affiliation: Sanofi Synthelabo (I) Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes mellitus, as defined by the World Health Organization diagnosed within one year prior to the screening visit, and not on antidiabetic agents for at least 3 months.



2. Signed informed consent, obtained prior to any study procedure.
Exclusion criteria: E 01. Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic

disorders, drug or chemical agent intakeâ?¦).



E 02. HbA1c < 7.6% or > 9%.



E 03. Age < 18 or > 78 years old years.



E 04. Body mass index (BMI) > 35 kg/m².



E 05. Patients currently receiving or who have received any hypoglycemic agent within 3

months before screening visit.



Further details of exclusion criteria can be made available on request.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications

Intervention(s)

Intervention1: Glimepiride: Glimepiride (2 mg /day or 1 mg/day)tablets, orally, 24 week
Intervention2: Metformin: Metformin (500 mg bid)orally, 24 week
Control Intervention1: Glimepiride + Metformin: Glimepiride (2 mg /day or 1 mg/day) +
Metformin 500 mg bid
orally, 24 week

Primary Outcome(s)

Change in HbA1c from baseline (week 0) to V11 (week 24).Timepoint: Change in HbA1c from baseline (week 0) to V11 (week 24).

Secondary Outcome(s)

Efficacy :

Percentage of patients with HbA1c 7% and 6.5% at week 24. Change in FPG from baseline (week 0) to V11 (week 24).

Safety :

Adverse events, serious adverse event, physical examination (including body weight), vital signs, hematology, serum chemistry Frequency and incidence of hypoglycemia during the study period.Timepoint: Week 24

Secondary ID(s)

GLIME_R_05809 version 1 dated 22 June 2011

Source(s) of Monetary Support

Sanofi Synthelabo (I) Ltd A-101 Business Square Sir Mathuradas Vasanji Marg, Andheri (E), Mumbai-400 093

Ethics review

Status: Approved
Approval date: 01/02/2012
Contact:

Bhatia Hospital Medical Research Society Ethics Committee, Mumbai (Dr Siddharth Shah)

Status: Approved
Approval date: 02/02/2012
Contact:

Penta-Med Ethics Committee, Pune (Dr Mohan Magdum)

Status: Approved
Approval date: 04/02/2012
Contact:

Institutional Ethics Committee, Kolkata (Dr Sanjay Chatterjee)

Status: Approved
Approval date: 08/02/2012
Contact:

Bangalore Central Ethics Committee (Dr. Parmesh Shamanna)

Status: Approved
Approval date: 17/02/2012
Contact:

Institutional Ethics Committee for M.V. Hospital and Research Centre (Lucknow) (Dr Sandeep Kumar Gupta)

Status: Approved
Approval date: 18/02/2012
Contact:

Institutional Ethics Committee (MAGJ Hospital) (Dr Rajesh Nair)

Status: Approved
Approval date: 18/02/2012
Contact:

Magna Care Ethics Committee, Nashik (Dr Pravin Supe)

Status: Approved
Approval date: 20/02/2012
Contact:

Ethics Committee of Diabetes Thyroid Hormone Research Institute Pvt Ltd, Indore (Dr Sunil Jain)

Status: Approved
Approval date: 08/05/2012
Contact:

Bangalore Diabetes Hospital Ethics Committee (Dr Prasanna Kumar)

Status: Approved
Approval date: 25/05/2012
Contact:

Samvedna Hospital Ethics Committee (Dr Monika Gupta)