| CTRI Number |
CTRI/2021/03/031796 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
14/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the Overall Insulin Usage Pattern in Insulin-Naive Type 2 Diabetes Mellitus (T2DM) Patients retrospectively |
|
Scientific Title of Study
|
Retrospective EMR Database Study in India: Assessment of Overall Insulin Pattern in Insulin Naive T2DM Patients(REALITY) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OBS16624 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
Director |
| Affiliation |
Dr Mohan Diabetes Specialties Centre & Madras Diabetes Research Foundation |
| Address |
Dr Mohan Diabetes Specialties Centre & Madras Diabetes Research Foundation
No 6B Conran Smith Road Gopalapuram Chennai
Chennai
TAMIL NADU
600 086
India |
| Phone |
04443968888 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Romik Ghosh |
| Designation |
Senior Medical Advisor |
| Affiliation |
Sanofi India Limited |
| Address |
Sanofi House CTS No 117 B L&T Business Park Saki Vihar Road Powai Mumbai
Mumbai
MAHARASHTRA
400072
India |
| Phone |
02228032489 |
| Fax |
|
| Email |
romik.ghosh@sanofi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Romik Ghosh |
| Designation |
Senior Medical Advisor |
| Affiliation |
Sanofi India Limited |
| Address |
Sanofi House CTS No 117 B L&T Business Park Saki Vihar Road Powai Mumbai
Mumbai
MAHARASHTRA
400072
India |
| Phone |
02228032489 |
| Fax |
|
| Email |
romik.ghosh@sanofi.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sanofi India Limited |
| Address |
Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai – 400072 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Mohan |
Dr Mohan Diabetes Specialties Centre & Madras Diabetes Research Foundation |
Dr Mohan Diabetes Specialties Centre & Madras Diabetes Research Foundation
No 6B Conran Smith Road Gopalapuram Chennai 600 086 India
Chennai
TAMIL NADU |
914443968888
drmohans@diabetes.ind.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Male or female aged ≥ 18 years
• Patients with known case of type 2 diabetes mellitus
• Insulin naïve patients
• Treatment started with any type of insulin during the index period of 01 January 2016 to 31 December 2018
• Data of patients to be available for minimum of 6 months after starting insulin therapy
|
|
| ExclusionCriteria |
| Details |
• Known case of type 1 diabetes mellitus, type 2 diabetes mellitus of <5 years duration, gestational diabetes and secondary diabetes (Eg. fibrocalculus pancreatic diabetes)
• Patients with cancer, end stage liver disease, end stage renal failure
• Treatment with short term insulin therapy (< 1 month) and other investigational drugs concurrently during the retrospective data collection period
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the demographic profile of T2DM patients initiated on insulin (prior to insulin initiation) |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To analyze the longitudinal outcomes in the subset of patients initiated on Glargine (U100 and U300). |
12 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "1006"
Final Enrollment numbers achieved (India)="1006" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2021 |
| Date of Study Completion (India) |
20/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational, retrospective study in India to examine the real-world usage patterns of insulin initiated in the treatment of type 2 diabetes (T2DM) and the longitudinal outcomes of those who were initiated on insulin glargine (Glargine 100 U/mL and Glargine 300 U/ML). Eligible patients would be adult (≥ 18 years) male or female insulin naïve with known case of T2DM who had been initiated with any type of insulin during the index period from 01 January 2016 to 31 December 2018. Baseline visit will be defined as the index date. Data would be collected for a follow up of a minimum of 6 months to a maximum of 12 months of those patients who were initiated on insulin glargine. Required data mentioned in baseline characteristics will be recorded at index date, second visit at 3 months (+/-1 month), 6 months (+/-2 months) and 12 months (+/-2 months) after index date of treatment. Data will be collected through the abstraction of electronic medical records (EMRs) from 15 sites in India. Collected study data will include patient characteristics, duration of diabetes, treatment details, comorbidities, glycemic parameters and hypoglycaemia as reported. Data from the patients who had received any type of insulin during the index period will be recorded as per the defined outcomes. Data will be extracted from electronic health records and will be abstracted by a CRO (clinical research organization), the principal investigator (PI) or a reviewer (clinical research associate) nominated by the sponsor. For the records missing any of the requested information, data will be reported as missing |