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.

Phase 3

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

• Registration Number: CTRI/2022/07/044040
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Type 2 Diabetes Mellitus diagnosed within 2 years with

2. HbA1c <9 %.

Exclusion Criteria

1. Age <18 years or > 65 years.

2. BMI <23kg/m2

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 <60 ml/min/1.73m2.

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 <3 months duration

13.On steroid treatment.

14.Pregnancy / Lactation

15. Drug specific CI like MCT, MEN2.

16. Positive GAD

17. Fasting C -peptide <1.2 ng/ml

18. Post COVID-Diabetes (onset of diabetes within 3 months of COVID)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>2.To compare remission rates between Metformin, Dapagliflozin and Semaglutide combination therapy and Metformin and other anti-hyperglycemic agents. <br/ ><br>Timepoint: At baseline, after 6 months, after 12 months, and after 18 months..

Secondary Outcome Measures

Name	Time	Method
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. <br/ ><br>Timepoint: At baseline, after 6 months, after 12 months and after 18 months.