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REVERSAL OF DIABETES WITH MEDICAL THERAPY

A RANDOMIZED CONTROLLED TRIAL TO STUDY THE REVERSIBILITY OF TYPE 2 DIABETES MELLITUS USING COMBINATION DRUG THERAPY OF LIRAGLUTIDE AND DAPAGLIFLOZIN AS AN ADD-ON TO METFORMIN MONOTHERAPY IN COMPARISON TO STANDARD MEDICAL MANAGEMENT

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/039920
Enrollment
56
Registered
2022-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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: Diet, exercise, metformin, dapagliflozin,liraglutide: Diet as per nutritionist advise for weight loss and diabetes mellitus Exercise of atleast 45 minutes brisk walk per day, 5 days a w

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Type 2 Diabetes mellitus, diagnosed within 2 years, with HbA1c Type 2 Diabetes mellitus diagnosed within 2-5 years, with HbA1c less than 8% if on no medications, less than 7.5% if on monotherapy, less than 6.5% if on more than one drug, with not more than one drug at maximal doses.

Exclusion criteria

Exclusion criteria: BMI less than 23kg/m2 Receiving treatment with atleast two anti diabetic medications at maximal doses Current insulin/GLP-1 analogue or SGLT-2 inhibitor therapy Acute or chronic pancreatitis History of ketoacidosis Moderate to severe diabetic retinopathy Renal failure with EGFR less than 60ml/min/1.73m2 24 hour urine protein more than 500mg/day Liver failure defined as ALT more than 3 times ULN or total bilirubin more than 2mg/dL or USG evidence of cirrhosis Any major chronic illness Evidence of macro vascular complications of Diabetes mellitus( coronary artery disease, heart failure, peripheral occlusive vascular disease, diabetic foot) On treatment with steroids Pregnancy or lactation Drug specific contraindications like history of medullary thyroid carcinoma or MEN2 Fasting C peptide levels less than 1.2ng/ml Positivity for anti GAD-65 antibody

Design outcomes

Primary

MeasureTime frame
Rate of remission of diabetes mellitusTimepoint: 3 months after the end of treatment

Secondary

MeasureTime frame
To measure changes in beta cell functionTimepoint: At 0 weeks and after 12 weeks of glycemic control

Countries

India

Contacts

Public ContactDr ANAND S

PGIMER

ramawalia@rediffmail.com9872997438

Outcome results

None listed

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