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CTRI Number  CTRI/2024/05/067588 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to assess the effect of a combination of glucose lowering medicines in prevention of type 2 diabetes among women with previous history of gestational diabetes mellitus and having pre-diabetes 
Scientific Title of Study   Drug InterVentIon for preveNtion of type 2 diabEtes among women with prior gestational diabetes mellitus and pre-diabetes in South Asia (DIVINE) - A Randomized Control Trial 
Trial Acronym  DIVINE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhil Tandon 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Room No.-312, 3rd Floor, Biotechnology Block, AIIMS, Ansari Nagar

South West
DELHI
110029
India 
Phone  01126593433  
Fax    
Email  nikhil_tandon@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikhil Tandon 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Room No.-312, 3rd Floor, Biotechnology Block, AIIMS, Ansari Nagar

South West
DELHI
110029
India 
Phone  01126593433  
Fax    
Email  nikhil_tandon@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikhil Tandon 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Room No.-312, 3rd Floor, Biotechnology Block, AIIMS, Ansari Nagar

South West
DELHI
110029
India 
Phone  01126593433  
Fax    
Email  nikhil_tandon@hotmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) 
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR) 
Address  Indian Council of Medical Research (ICMR), Ansari Nagar East, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikhil Tandon  All India Institute of Medical Sciences  Room No.-312, 3rd Floor, Biotechnology block, AIIMS, Ansari Nagar, Delhi-110029
South West
DELHI 		 011-26593433

nikhil_tandon@hotmail.com 
Dr Ankush Desai  Goa Medical College  Department of Endocrinology, 8th Floor, Superspeciality Block, Bambolim, Goa-403202
South Goa
GOA 		 9923486199

ankush_desai@rediffmail.com 
Dr Abilash Nair  Government Medical College  Room no. B2, Department of Endocrinology, Near Ward 20, Opp Ortho Lecture Hall, Main hospital building, Government Medical College Hospital, Thiruvananthapuram-695011
Thiruvananthapuram
KERALA 		 9495378383

abhimck@gmail.com 
Dr Sadishkumar Kamalanathan  JIPMER  Department of Endocrinology, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, Puducherry-605006
Pondicherry
PONDICHERRY 		 9629528518

sadishkk@gmail.com 
Dr Suraj Kubihal  Karnataka Institute of Medical Sciences   Department of Endocrinology, PMSSY building 2nd floor, Karnataka Institute of Medical Sciences, PB road, Vidyanagar, Hubli, Karnataka, India - 580021
Dharwad
KARNATAKA 		 8810534215

surajkubihal@gmail.com 
Dr V Mohan  Madras Diabetes Research Foundation  No. 4, Conran Smith Road, Gopalapuram, Chennai - 600 086
Chennai
TAMIL NADU 		 9840097370

drmohans@diabetes.ind.in 
Dr Sanjay Kumar Bhadada  PGIMER  Department of Endocrinology, PGIMER, Chandigarh-160012
Chandigarh
CHANDIGARH 		 9876602448

bhadadask@rediffmail.com 
Dr Jyotsna Suri  Safdarjung Hospital  Ward 8, Room no 118, 1st floor, Department of Obst & Gynae,VMMC & Safdarjung Hospital, New Delhi-110029
South West
DELHI 		 9810858358

jyotsnasuri@gmail.com 
Dr Tushar Bandgar  Seth GSMC and KEM Hospital  Seth GSMC & KEM Hospital, Department of Endocrinology, 1st Floor, OPD building, OPD 103, Parel, Mumbai-400012
Mumbai
MAHARASHTRA 		 9820025037

drtusharb@gmail.com 
Dr Nishant Raizada  University College of Medical Sciences and Guru Teg Bahadur Hospital   Room no 308, Centre for Diabetes Endocrinology and Metabolism, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi-110095
East
DELHI 		 9868261597

drnishantraizada@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Human Ethics Committee, Government Medical College, Thiruvananthapuram  Submittted/Under Review 
Institute Ethics Committee, All India Institute of Medical Sciences, Delhi  Approved 
Institutional Ethics Committee – Human Research (IEC-HR) University College of Medical Sciences, Delhi  Submittted/Under Review 
Institutional Ethics Committee, Goa Medical College, Goa  Submittted/Under Review 
Institutional Ethics Committee, JIPMER, Puducherry  Submittted/Under Review 
Institutional Ethics Committee, PGIMER, Chandigarh  Submittted/Under Review 
Institutional Ethics committee, Seth GSMC and KEM Hospital, Mumbai  Submittted/Under Review 
Institutional Ethics Committee, VMMC & Safdarjung Hospital, Delhi  Submittted/Under Review 
KIMS Ethics committee, Hubli  Submittted/Under Review 
MDRF Ethics Committee, Chennai  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  History of gestational diabetes mellitus and are pre-diabetic 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drug InterVentIon for preveNtion of type 2 diabEtes (DIVINE)  All participants will undergo 4-weeks active run-in with metformin SR (500mg for 2 weeks / 1000mg daily for 2 weeks) once daily. Based on pill count, individuals with more than 80% compliance who tolerate run-in therapy will be randomised in equal numbers to two groups; metformin SR 1000mg daily + vildagliptin 100mg once daily and vildagliptin placebo + metformin placebo once daily. All participants will be offered a lifestyle intervention.  
Comparator Agent  Placebo  Placebo mimicking drug combination of vildagliptin placebo + metformin placebo will be given once daily. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Most recent pregnancy affected by GDM within past 60 months 2. Currently diagnosed to be pre-diabetic
 
 
ExclusionCriteria 
Details  1. Pregnancy planned or inadequate contraception
2. Currently pregnant or lactating
3. Established Type 2 Diabetes Mellitus
4. Known renal insufficiency, liver disease and/or anaemia
5. Intolerance to either metformin or vildagliptin
6. Other indication of metformin 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of women who develop type 2 diabetes mellitus, at or prior to final visit (based on oral glucose tolerance test)  At 6 months, 12 months, 18 months, 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of women with change in glycaemic category to normal glucose tolerance (based on Oral Glucose Tolerance Test), BMI, Waist circumference, Health-related quality of life, Treatment tolerability   At 6 months, 12 months, 18 months, 24 months 
 
Target Sample Size   Total Sample Size="1110"
Sample Size from India="1110" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Given the high prevalence of Gestational Diabetes Mellitus (GDM) with high conversion rates to T2DM after child birth in South Asia, prevention of T2DM is a key policy focus in the region. The focus on preventive strategies in the younger population has been on lifestyle interventions. With limited evidence base on effective and affordable lifestyle approaches in resource-constraint settings, a need was felt to investigate low-cost and scalable preventive drug therapies. 

The study planned is a randomized, double-blind placebo controlled trial to evaluate the effectiveness of combination of metformin and vildagliptin in prevention of diabetes in women with prior GDM and having prediabetes in the postpartum period. Women with recent GDM will be approached and screened for pre-diabetes. Pre-diabetic women will be given a 1-month run-in with Metformin SR (500 mg for 2 weeks/1000 mg for 2 weeks) once daily. Patients with more than 80% compliance will be randomized into two groups: Intervention - combination of vildagliptin 100 mg and metformin 1000mg once daily; Control - placebo mimicking drug combination once daily. Planned median treatment and follow-up will continue for 24 months with development of T2DM by OGTT (using ADA) being the primary outcome. 

If this drug combination comes out to be efficacious and safe, the results will impact guideline recommendations not just in South Asia and other lower middle income group setting with a similar GDM disease burden but also high-risk population globally.

 
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