Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Academic Trial
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 18 years (male and female) 2. Diagnosed with T2D within the last one year HbA1c level: 7.0 percentage to 9.5 percentage (both inclusive) 3. Drug-naive or on oral anti-diabetic medications within the last one year 4. Drug naive for GLP 1 agonists
Exclusion criteria
Exclusion criteria: 1. Type 1 Diabetes Mellitus (T1DM) 2. Gestational Diabetes Mellitus (GDM) 3. Maturity Onset Diabetes of the Young (MODY) 4. Current ongoing steroid therapy 5. History of pancreatitis 6. Known Cup-to-disc ratio less than 0.2 7. History of Proliferative retinopathy or maculopathy requiring acute treatment (verified within 90 days prior to screening) 8. Osmotic symptoms 9. Personal or family history of medullary thyroid carcinoma (MTC) or MEN 2 10. eGFR less than 15 mL per min per 1.73 m? within the last one year 11. History of heart failure (New York Heart Association class IV) 12. History of Gallstones 13. History of malignant neoplasms within the last 5 years 14. Pregnant or planning pregnancy up to 9 months after enrollment 15. Already on insulin therapy or requires initiation of insulin therapy 16. Known hypersensitivity to OS or OADs or other GLP-1 analogues
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (%) from baseline to week 26.Timepoint: 26 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Fasting Plasma Glucose- FPG (mg/dL),Post Prandial Plasma Glucose- PPPG (mg/dL), Body Mass Index- BMI (kg/m2), Waist circumference (cms), body weight (kgs), SBP (mm of Hg), DBP (mm of Hg) Urine albumin-to-creatinine ratio -UACR, and lipid profile(TC (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), TG (mg/dL) -from baseline to week 26Timepoint: 26 weeks;The study will evaluate the percentage of patients achieving more than 1% HbA1c reduction with more than 3% or more than 5% weight loss, both with and without severe hypoglycemia, at the end of the study.Timepoint: at the end of the study;The proportion of patients discontinuing OS due to Gastrointestinal (GI) related AEs, treatment emergent adverse events (TEAEs) and the number of self-reported severe hypoglycemic episodes.Timepoint: at the end of the study;LFTs (AST (IU/L), ALT (IU/L), and Serum bilirubin (mg/dl)) and STOP-Bang Score from baseline to week 26.Timepoint: 26 weeks | — |
Countries
India
Contacts
Public ContactDr Krishna G Seshadri
Apollo Speciality Hospitals
Outcome results
None listed