Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
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
| Measure | Time frame |
|---|---|
| Rate of remission of diabetes mellitusTimepoint: 3 months after the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure changes in beta cell functionTimepoint: At 0 weeks and after 12 weeks of glycemic control | — |
Countries
India
Contacts
PGIMER