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CTRI Number  CTRI/2025/09/094775 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Single Arm Study 
Public Title of Study   A Study Assessing Diabetes Remission in Participants Receiving Tirzepatide and Dapagliflozin with metformin as Intervention  
Scientific Title of Study   A pilot study to investigate remission of Type 2 Diabetes using combination of Tirzepatide and Dapagliflozin as an adjunct to Metformin 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunil Mishra 
Designation  Senior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no.9 Ground FLoor Nehru Hospital Extension (NHE), PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9599591859  
Fax    
Email  drsmpgi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RAMA WALIA 
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no.10 Ground FLoor Nehru Hospital Extension (NHE), PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  09872997438  
Fax    
Email  Ramawalia@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  RAMA WALIA 
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no.10 Ground FLoor Nehru Hospital Extension (NHE), PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  09872997438  
Fax    
Email  Ramawalia@rediffmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research 
Address  Sector-12, Chandigarh PIN- 160012, INDIA. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sunil Mishra  Post Graduate Institute of Medical Education and Research   Room no.9 Ground FLoor Nehru Hospital Extension (NHE), PGIMER, Chandigarh
Chandigarh
CHANDIGARH 
9599591859

drsmpgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  na  na 
Intervention  Tirzepatide + Dapagliflozin + Metformin  The proposed intervention involves administering tirzepatide and dapagliflozin together, added to a background of metformin therapy in patients with type 2 diabetes. (6-9 months) The intervention involves subcutaneous Tirzepatide, starting at 2.5 mg once weekly for the first 4 weeks and then increasing to 5 mg weekly, oral Dapagliflozin at 10 mg once daily, and oral Metformin titrated up to 2 g daily. All three medications are administered as adjuncts for a total duration of 24 weeks (6 months). After this period, the drugs are gradually tapered and stopped over another 6 weeks, with ongoing monitoring of glycaemic status throughout and after discontinuation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diabetes Mellitus type 2 diagnosed within 2 years. 
 
ExclusionCriteria 
Details  BMI less than 23kg per m2
Current Insulin or GLP1 analogue or SGLT2 inhibitor therapy.
Acute or Chronic Pancreatitis
History of Ketoacidosis
Objective evidence of Diabetic Neuropathy.
Renal Failure defined as eGFR less than 60 ml per min per 1.73m2.
24hr Urinary protein more than 500 mg or Albumin to Creatinine ratio more than 300mg per g.
Moderate to Severe NPDR or PDR or diabetic maculopathy.
Liver disease defined as ALT more than 3 times ULN, Bilirubin more than 2 mg per dl, USG evidence of Cirrhosis.
Any major chronic illness.
Symptomatic Coronary artery disease or Peripheral arterial disease or cardiac

Failure or Acute coronary syndrome less than 3 months duration
Diabetic Foot
On steroid treatment.
Pregnancy or Lactation
Drug specific contraindications like Medullary Thyroid Ca, MEN2.
Positive GAD
Fasting C -peptide less than 1.2 ng per ml
Post COVID-Diabetes (onset of diabetes within 3 months of COVID) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the remission rates in individuals with Diabetes mellitus Type 2 receiving a combination of oral Tirzepatide and Dapagliflozin in addition to Metformin monotherapy, and to compare these rates with standard diabetes management practices.  At Baseline, after 9 months  
 
Secondary Outcome  
Outcome  TimePoints 
To measure changes in beta- cell function following treatment, as assessed by mixed meal tolerance test.  At Baseline, after 9 months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/09/2025 
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="1"
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  

Type 2 diabetes mellitus (T2DM) represents a significant and escalating global health challenge, characterized by chronic hyperglycaemia resulting from insulin resistance, impaired insulin secretion, or both. The long-term complications associated with T2DM, including cardiovascular disease, nephropathy, retinopathy, and neuropathy, impose a substantial burden on individuals and healthcare systems worldwide. While current management strategies primarily focus on achieving and maintaining glycaemic control to prevent these complications, the concept of achieving disease remission has gained increasing attention as a more ambitious and potentially impactful therapeutic goal. Remission, defined as the sustained achievement of non-diabetic glycaemic levels without the need for glucose-lowering medications, holds the promise of reducing the risk of long-term complications, improving patients’ quality of life, and potentially decreasing healthcare expenditures.

This pilot study aims to investigate the efficacy and safety of a novel triple combination therapy involving Tirzepatide, Dapagliflozin, and Metformin for inducing remission in patients with type 2 diabetes. Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, represents a new class of incretin-based therapies demonstrating remarkable efficacy in glycaemic control and weight loss 1. Dapagliflozin, a selective sodium-glucose cotransporter-2 (SGLT2) inhibitor, lowers blood glucose by increasing urinary glucose excretion and has shown significant cardiovascular and renal benefits 2. Metformin, a biguanide, remains the cornerstone of initial pharmacological treatment for T2DM due to its effectiveness in reducing hepatic glucose production and improving insulin sensitivity, coupled with a favourable safety profile and long-term cardiovascular benefits 4. By combining these three agents, each with distinct yet complementary mechanisms of action, this study seeks to explore the potential for a synergistic effect that could lead to a higher rate of diabetes remission compared to existing treatment paradigms.

 
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