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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	CTRI
Last refreshed on:	24 November 2021
Main ID:	CTRI/2018/02/012158
Date of registration:	26-02-2018
Prospective Registration:	Yes
Primary sponsor:	Sanofi India Limited
Public title:	A observational study assessing the real world data on inititating treatment of Toujeo after oral antidiabetic drug failure in insulin-naive patients with Type 2 Diabetes Mellitus patients.
Scientific title:	A 12â??month prospective observational study assessing the real-world clinical effectiveness, safety and health-economic benefits of ToujeoÂ® initiation after oral antidiabetic drug failure in insulin-naÃ¯ve patients with type 2 diabetes mellitus - ATOS
Date of first enrolment:	09-03-2018
Target sample size:	4525
Recruitment status:	Not Yet Recruiting
URL:	http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22821
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:	N/A

Countries of recruitment
Colombia	Egypt	India	Indonesia	Israel	Jordan	Kazakhstan	Kuwait
Lebanon	Mexico	Peru	Philippines	Qatar	Russian Federation	Saudi Arabia	Singapore
Taiwan	Thailand	Ukraine	United Arab Emirates

Contacts

Name:	DrGodhuli Chatterjee
Address:	Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbaiâ?? 400072 400072 Mumbai, MAHARASHTRA India
Telephone:	02228032822
Email:	Godhuli.Chatterjee@sanofi.com
Affiliation:	Sanofi India Limited

Name:	Ekata Shah
Address:	Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai 400072 Mumbai, MAHARASHTRA India
Telephone:	02228032822
Email:	Godhuli.Chatterjee@sanofi.com
Affiliation:	Sanofi India Limited

Key inclusion & exclusion criteria

Inclusion criteria: 1. Signed patient informed consent;

2. Type 2 diabetes mellitus;

3. Treated with at least 1 OAD for at least 6 months;

4. Legal age of adulthood, but at least >=18 years;

5. HbA1c >7.0 % and <=11% within 3 months of study baseline;

6. Physiciansâ?? decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen

Exclusion criteria: 1. Diabetes mellitus other than type 2;

2. Existing or previous treatment with insulin or other injectable antidiabetic drugs. The

following is allowed:

- Previous short-term insulin treatment due to an intercurrent medical condition,

with treatment duration not exceeding 10 concurrent days in the past year;

- Previous insulin treatment of gestational diabetes, if the patient has discontinued

insulin treatment more than a year ago.

3. Contraindication to insulin glargine U300 according to local product labelling;

4. Pregnancy, breastfeeding or pregnancy planned during the course of the study;

5. Drug or alcohol abuse within the past year;

6. Concomitant disease with life expectancy of less than 1 year;

7. Concomitant participation in a clinical trial

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)

Control Intervention1: NA-Product Registry: NIL

Primary Outcome(s)

Percentage of patients achieving the predefined individualized HbA1c goal at 6th monthTimepoint: 6th Month

Secondary Outcome(s)

Efficacy endpoints:

1.Percentage of patients achieving the predefined individualized HbA1c goal at Months 3 and 12;

2. Percentage of patients with HbA1c 7% at Months 3, 6 and 12;

3. Percentage of patients achieving an HbA1c 7.5% in patients over 65 years at Month 3, 6 and 12;

4. Percentage of patients reaching predefined individualized HbA1c goal at Months 3, 6 and 12 depending on baseline HbA1c value (8%, 8% to 10% and 10%);Timepoint: 3, 6 and 12 months

Secondary ID(s)

OBS14708

Source(s) of Monetary Support

Sanofi India Limited Sanofi House, CTS No.117-B, L&T Business Park Saki Vihar Road, Powai Mumbai:400072

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 29/01/2018
Contact:

Sir Ganga Ram Hospital_Dr. Surender Kumar

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Aravinda Jagadeesha

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr B M Makkar

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Dakshata Padhye

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Jothydev Kesavadev

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Rajeev Chawla

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Ravindranath Venkatesan

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Rishi Shukla

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Sailesh Lodha

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Sanjeev Pathak

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Shivaa Mohan

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Shobha Devi

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Surendra Kumar Sharma

Status: Approved
Approval date: 09/02/2018
Contact:

JCDC_Dr Vivek Sundaram

Status: Approved
Approval date: 10/02/2018
Contact:

Institutional Ethics Committee Poona Medical Research Foundation Dr. Sanjay Aggarwal

Status: Approved
Approval date: 10/02/2018
Contact:

Institutional Ethics Committee_Dr. Sanjay Agarwal