Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Hetero-Semaglutide injection: Start with 0.25 mg once weekly for 4 weeks followed by 0.5 mg once weekly for 4 weeks.
Further dose titration to 1mg and 2mg will be done if HbA1c levels a
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients aged 18-65 years with diagnosis of type 2 diabetes mellitus. 2. Patients who are on Metformin greater than or equal to 1500mg per day for about 12 weeks before screening. 3. Patients with glycosylated haemoglobin (HbA1c) greater than or equal to 7.0 percentage and less than or equal to 11.0 percentage at screening.
Exclusion criteria
Exclusion criteria: 1. Patients with known Type I diabetes mellitus or secondary diabetes mellitus 2. Patients with history of two or more episodes of severe hypoglycemia within 6 months prior to screening 3. Patients having a history of metabolic acidosis or diabetic ketoacidosis or hyperosmolar state, with or without coma. 4. Patients with severe renal impairment as an estimated glomerular filtration rate less than 30 mL/min/1.73 meter square as calculated by chronic kidney disease-epidemiology collaboration as determined by central laboratory. 5. Patients with hyperthyroidism or hypothyroidism at screening (except those with stable drug dose control for more than 3 months and normal thyroid function tests) or clinically significant abnormal thyroid function test results at screening and requiring drug treatment. 6. Have been taking any other glucose lowering agent(s) other than metformin during the last 12 weeks prior to screening (short-term treatment (no longer than 14 days in total) with insulin in connection with inter-current illness allowed). 7. Patient with any of the following laboratory abnormality at screening a. Haemoglobin less than 10 gm/dl b. Neutrophils less than 1500/mm3 c. Platelets less than 100,000/mm3 d. Fasting plasma glucose greater than or equal to 270 mg/dL e. Total bilirubin greater than 1.5 X ULN f. ALT/ AST greater than 3 X ULN g. Serum amylase and/or lipase greater than 3.0 X ULN h. Serum calcitonin greater than 50 ng/L i. QTc interval greater than 450 msec in men and greater than 470 msec in women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in glycosylated haemoglobin (HbA1c)Timepoint: Baseline to end of 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in HbA1cTimepoint: Baseline to end of 12 Weeks;The proportion of patients who achieved HbA1C less than 7.0 percentageTimepoint: At the End of 12 and 24 Weeks;Mean change in fasting plasma glucose (FPG) levelsTimepoint: Baseline to end of 4, 8, 12, 16, 20 and 24 Weeks;Mean change in postprandial plasma glucose (PPG) levelsTimepoint: Baseline to end of 4, 8, 12, 16, 20 and 24 Weeks;Mean change in body weightTimepoint: Baseline to end of 12 and 24 Weeks.;Proportion of patients who achieved body weight loss greater than or equal to 5 percentage and greater than or equal to 10 percentageTimepoint: At the End of 12 and 24 Weeks.;Proportion of patients who develop anti-drug antibodies (ADA) to SemaglutideTimepoint: Baseline to end of 12 and 24 Weeks;Proportion of patients with hypoglycaemic episodesTimepoint: Baseline to end of 12 and 24 Weeks;Treatment emergent clinical and laboratory adverse events (TEAEs)Timepoint: Baseline to end of 24 Weeks;Proportion of patients who require rescue medicationsTimepoint: Baseline to end of 24 Weeks | — |
Countries
India
Contacts
Public ContactMohan Reddy Bandi
Hetero Labs Limited
Outcome results
None listed