A Study Assessing Diabetes Remission in Participants Receiving Tirzepatide and Dapagliflozin with metformin as Intervention

A pilot study to investigate remission of Type 2 Diabetes using combination of Tirzepatide and Dapagliflozin as an adjunct to Metformin - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094775

Enrollment

Registered

2025-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Tirzepatide + Dapagliflozin + Metformin: The proposed intervention involves administering tirzepatide and dapagliflozin together, added to a background of metformin therapy in patients

Eligibility

Inclusion criteria

Inclusion criteria: Diabetes Mellitus type 2 diagnosed within 2 years.

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
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.Timepoint: At Baseline, after 9 months	—

Secondary

Measure	Time frame
To measure changes in beta- cell function following treatment, as assessed by mixed meal tolerance test.Timepoint: At Baseline, after 9 months	—

Countries

India

Contacts

Public ContactRAMA WALIA

Post Graduate Institute of Medical Education and Research

Ramawalia@rediffmail.com09872997438

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026