REVERSAL OF DIABETES WITH MEDICAL THERAPY

Phase 4

Completed

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

• Registration Number: CTRI/2022/02/039920
• Lead Sponsor: PGIMER Chandigarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-31
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 29

Inclusion Criteria

Type 2 Diabetes mellitus, diagnosed within 2 years, with HbA1c <8.5% if on no medications, HbA1c less than 7.5% if on mono therapy, or less than 7% if on more than one drug, with not more than one drug at maximal doses.

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified