| 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
|
|
|
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
|
|
|
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
|
|
|
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. |