"IDMPS will be an international, multicenter, observational study with a cross-sectional study to assess current practices in the management in the patients with type 1 and type 2 diabetes mellitus non-interventional on therapeutic strategy"

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2012/02/002407
• Date of registration: 07-02-2012
• Prospective Registration: No
• Primary sponsor: Sanofi Synthelabo I Ltd
• Public title: "IDMPS will be an international, multicenter, observational study with a cross-sectional study to assess current practices in the management in the patients with type 1 and type 2 diabetes mellitus non-interventional on therapeutic strategy"
• Scientific title: International Diabetes Management Practices Study - IDMPS
• Date of first enrolment: 07-01-2012
• Target sample size: 12519
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4100
• 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

Algeria, Argentina, Cameroon, Colombia, Egypt, Georgia, India, Jordan, Kazakhstan, Lebanon, Morocco, Pakistan, Russian Federation, Saudi Arabia, Senegal, Tunisia, Turkey, Ukraine, United Arab Emirates, Uzbekistan, Venezuela (Bolivarian Republic of)

Contacts

• Name: Ms Gayatri Jaiswal
• Affiliation: Sanofi Synthelabo (I) Ltd

• Name: Ms Gayatri Jaiswal
• Affiliation: Sanofi Synthelabo (I) Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. All male and female adult patients (who have attained majority) diagnosed with type 1 and type 2 DM ,visiting physician during the recruitment period of the cross-sectional study, up to the number of patients allocated to the physician.



2. Written Informed Consent


Exclusion criteria: 1. Concomitant participation to a clinical trial

2. Previous participation in this study

3. Current temporary insulin therapy (gestational diabetes, surgery, pancreas cancer)



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Type 1 and Type 2 Diabetes Mellitus Health Condition 2: E109- Type 1 diabetes mellitus without complications

Primary Outcome(s)

Primary Objective: To assess the therapeutic management of type 2 diabetic patients in the current medical practice.Timepoint: This is observational study. The outcome will be assessed at the time of statistical analysis, planned in Q4 2012

Secondary Outcome(s)

1. To assess the therapeutic management of type 1 diabetic patients in the current medical practice.



2. To assess the proportion of patients under the HbA1c threshold compared to the international recommendations.

Timepoint: This is observational study. The outcome will be assessed at the time of statistical analysis, planned in Q4 2012

Secondary ID(s)

DIREG_R_05941

Source(s) of Monetary Support

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

Ethics review

Status: Approved
Approval date: 07/11/2011
Contact:

Institutional Review Board, Silverline Hospital, Kochi (Tom Babu)

Status: Approved
Approval date: 15/11/2011
Contact:

Ethics Committee Jothydevâ??s Diabetes and Research Centre, Kerala (Jothydev)

Status: Approved
Approval date: 21/11/2011
Contact:

SG DIabetes Centre Ethics Committee, Delhi (Sanjay Gupta)

Status: Approved
Approval date: 29/11/2011
Contact:

Central Ethics Committee Apollo Hospitals Group (New Delhi) (Chander Mohan Batra)

Status: Approved
Approval date: 29/11/2011
Contact:

Central Ethics Committee Apollo Hospitals Group, Kolkata (Sanjay Chatterjee)

Status: Approved
Approval date: 05/12/2011
Contact:

Ethics Committee for Diabetes Thyroid Hormone Research Institute Pt Ltd, Indore (Rajendra Jain)

Status: Approved
Approval date: 09/12/2011
Contact:

Clinical Ethics Forum (CEF) Chennai (A.Ramachandran)

Status: Approved
Approval date: 09/12/2011
Contact:

Ethics Committee, Park Clinic (Kolkata) Sudip Chatterjee

Status: Approved
Approval date: 10/12/2011
Contact:

Institutional Ethics Committee Columbia Asia Hospitals, Bangalore (R Janakiraman)

Status: Approved
Approval date: 27/12/2011
Contact:

BEDRC Ethics Committee on Human Research, Bangalore (Mala Dharmalingam)

Status: Approved
Approval date: 27/12/2011
Contact:

Institutional Ethics Committee, G. Kuppuswamy Naidu Memorial Hospital, Coimbatore (Ramalingam Srinivasan)