Diabetes is considered to be a chronic disease requiring prolonged medication. Recent evidences shows that Diabetes can be reversed or in other words can be controlled to that extent when there might not be any requirement for medicine. We will try to achieve that among our patients.

A randomized control trial to study the reversibility of Type 2 Diabetes Mellitus using combination drug therapy of Semaglutide and Dapagliflozine as an add on to Metformin monotherapy in comparison to standard clinical management and to find the reversibility of alterations in proteomics and immune inflammatory markers after remission of diabetes

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044040

Enrollment

Registered

2022-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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: SEMAGLUTIDE ORAL PLUS DAPAGLIFLOZIN PLUS METFORMIN: PATIENT WILL BE RANDOMIZED TO TRIAL AND COMPARATOR ARM. TRIAL ARM PATIENT WILL RECEIVE ORAL SEMAGLUTIDE 3 MG ONCE A DAY, THEN DOSES W

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type 2 Diabetes Mellitus diagnosed within 2 years with 2. HbA1c

Exclusion criteria

Exclusion criteria: 1. Age 65 years. 2. BMI 3. Current Insulin/ GLP1 analogue or SGLT-2 inhibitor therapy. 4. Acute or Chronic Pancreatitis 5. History of Ketoacidosis. 6. Objective evidence of Diabetic Neuropathy. 7. Renal Failure defined as eGFR 8. 24hr Urinary protein >500 mg or Albumin to Creatinine ratio >300mg/g. 9. Moderate to severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, diabetic maculopathy. 10. Liver disease defined as ALT > 3 times ULN, Bilirubin > 2 mg/dl, USG evidence of Cirrhosis. 11. Any major chronic illness. 12. Symptomatic Coronary artery disease/ Peripheral arterial disease/ cardiac failure/ diabetic foot/ Acute coronary syndrome 13.On steroid treatment. 14.Pregnancy / Lactation 15. Drug specific CI like MCT, MEN2. 16. Positive GAD 17. Fasting C -peptide 18. Post COVID-Diabetes (onset of diabetes within 3 months of COVID)

Design outcomes

Primary

Measure	Time frame
1.To find out proportion of patients with type 2 Diabetes Mellitus on Metformin monotherapy achieving remission with 6 months add on combination therapy with Dapagliflozin and Semaglutide. 2.To compare remission rates between Metformin, Dapagliflozin and Semaglutide combination therapy and Metformin and other anti-hyperglycemic agents. Timepoint: At baseline, after 6 months, after 12 months, and after 18 months..	—

Measure

Time frame

1.To find out proportion of patients with type 2 Diabetes Mellitus on Metformin monotherapy achieving remission with 6 months add on combination therapy with Dapagliflozin and Semaglutide. 2.To compare remission rates between Metformin, Dapagliflozin and Semaglutide combination therapy and Metformin and other anti-hyperglycemic agents. Timepoint: At baseline, after 6 months, after 12 months, and after 18 months..

—

Secondary

Measure	Time frame
To compare the improvement in Beta cell function pre and post intervention with Semaglutide, Dapagliflozin add on Metformin group and Other anti-hyperglycemic agent with add on Metformin group by Mixed Meal tolerance test. Timepoint: At baseline, after 6 months, after 12 months and after 18 months.	—

Countries

India

Contacts

Public ContactANANDA MOHAN CHAKRABORTY

ENDOCRINOLOGY, PGIMER

ramawaliapgimer@gmail.com9872997438

Outcome results

None listed

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