CTRI/2022/06/043254 [Registered on: 14/06/2022] Trial Registered Prospectively
Last Modified On:
19/06/2024
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Product Registry
Study Design
Other
Public Title of Study
An observational study to understand effectiveness, initiation (starting) and patient satisfaction of Insulin Glargine among type 2 Diabetes Mellitus patients in primary care settings in India
Scientific Title of Study
An observational study in PRIMARY Care settings in India to assess clinical outcomes, initiation patterns, and treatment-satisfaction in type 2 Diabetes Mellitus patients initiated on Insulin glargine (PRIMARY-India study)
First floor, Milestone Elite2, Opp. Gandhi Smruti Bhavan, Near Surat Peoples’ Bank, Nanpura-395 001 Surat GUJARAT
9624322255
dralok.83@gmail.com
Dr Jayesh Thakkar
Abhishek Hospital and Heart Center
Canara Bank, L.G. Corner, Maninagar, Ahmedabad,Gujarat- 380 008 Ahmadabad GUJARAT
9824038294
abhishekhospital@hotmail.com
Dr V Manjunath
Akshaya Medical Centre
Diabetic and Hypertensive Clinic N. 32/5, Karaneeswarar Koil Street, Mylapore, Chennai- 600 004 Chennai TAMIL NADU
9940033240
drmanjunathv@yahoo.com
Dr Paresh Shah
Amruta Hospital and Heart Centre
Amruta Hospital and Heart Centre Opp Bank of India Ramnagar Sabarmati Ahmedabad Gujarat 380 005 Ahmadabad GUJARAT
9824043205
pareshshah468@gmail.com
Dr Mihir Shah
Apollo Clinic Licensee
Indira Health and Lifestyle Private Ltd.,Xtrium, Ground Floor, Next to Holy Family Church, Andheri-Kurla Road, Chakala, Andheri-East, Mumbai- 400093 Mumbai MAHARASHTRA
9324312111
dr.mihirshah@gmail.com
Dr Tanmoy Chattopadhyay
Bablas doctors chamber
Below SBI building,(Santoshpur branch) Battala Bus stop,Santoshpur, Kolkata-700075 Kolkata WEST BENGAL
9874645221
chatterjeedrtanmoy@gmail.com
Dr Niraj Govani
Care Diabetes and Dental Clinic
3, Gr. Floor, Harivilla Complex, Near Z. M. Zala Commerce College, Near Kargil Petrol Pump, Ghatlodia, Ahmedabad-380061 Ahmadabad GUJARAT
Pala - Ponkunnam Rd, Kerala 686522, India Kottayam KERALA
9846359849
doctoreldho@gmail.com
DrAnoop N
Hayath Hospital
Hayath Hospital
Chavakad, Thrissur – 680506
Thrissur KERALA
9809619896
nanoop1988@gmail.com
Dr Nagraj S
Infilife Healthcare Private Limited
Preventive centre for diabetes and life style disease, #854, 10th Cross RBI Layout J.P.Nagar 7th Phase, Opp Someshwara Sabha Bhavana Bangluru 560078 Bangalore KARNATAKA
9900724069
drnagarajmed@gmail.com
Dr J RAMDAS
Jeevansai Hospitals
25, 26, Ganesh Temple - SBI Complex Road, Opposite HUDA Open Auditorium, Vanasthalipuram, Hyderabad, Telangana 500070, India Hyderabad TELANGANA
1. Male or female aged ≥ 18 years
2. Insulin-naïve type 2 diabetes patients, uncontrolled (HbA1c > 7%), on at least 1 oral antidiabetic drug (OAD) for a minimum period of 6 months, initiated on insulin glargine (Lantus® / Toujeo®) in out-patient primary care settings
3. Signed informed consent form.
Note: Insulin glargine should be administered up to 7 days prior to informed consent or within 2 days after informed consent independent of this study
ExclusionCriteria
Details
1. Known cases of type 1 diabetes mellitus and secondary diabetes.
2. Clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 6-month follow-up.
3. Current or planned pregnancy or lactating women
4. Patients on an investigational drug or have participated in a clinical trial in the previous 3 months
5. Contraindication to Lantus® and Toujeo® according to local product labelling
6. Patents requiring short-term insulin therapy
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Mean change in HbA1c from baseline to 6 months
Mean change in HbA1c from baseline to 6 months
Secondary Outcome
Outcome
TimePoints
1. Number of adverse events and serious adverse events and hypoglycemic events in overall population
2. Change in insulin dose in overall population.
3. Change in body weight in
overall population.
4. Physician satisfaction scores at 6 months in overall population.
5. Patient treatment-satisfaction scores at 6 months in overall population
03 Months
06 Months
Target Sample Size
Total Sample Size="450" Sample Size from India="450" Final Enrollment numbers achieved (Total)= "446" Final Enrollment numbers achieved (India)="446"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a national prospective, multicenter, observational study. This Indian study will mirror real life management of patients who have been initiated on insulin glargine (lantus® and toujeo®). The data will be collected from urban (megacities with population >10 million) and semi urban population (cities with population between 1 – 10 million) (9). This strategy will enhance the significance of the results and allow analyses on an urban/semi urban basis because management patterns vary between these two settings.
This study in a primary care setting will help us to understand:
Initiation patterns
Clinical outcomes
Physician satisfaction
Patient treatment-satisfaction
in T2DM patients initiated on insulin glargine (Lantus® and Toujeo®. The study will also attempt to understand the outcomes and initiation patterns in urban and semi-urban Indian sub-populations