Health Condition 1: null- Type 2 Diabetes Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Oral Semaglutide
: Once daily dose of 3mg, 7mg and 14mg of oral semaglutide
Total duration 52 week
Control Intervention1: Placebo: Once daily dose of 3mg, 7mg and 14mg of placebo orally
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2Male or female, age above or equal to 18 years at the time of signing informed consent. 3Diagnosed with type 2 diabetes mellitus >= 90 days prior to the day of screening. 4HbA1c of 7.0-9.5 percentage(53-80 mmol/mol) (both inclusive). 5Stable treatment with one of the following insulin regimens (minimum 10 IU/day) >= 90 days prior to the day of screening. Maximum 20% change in total daily dose is acceptable: 1Basal insulin alone 2Basal and bolus insulin in any combination 3Premixed insulin including combinations of soluble insulins 4Concomitant treatment with stable daily dose of metformin (>= 1500 mg or maximum tolerated dose as documented in the subject medical record) >= 90 days prior to the day of screening is allowed.
Exclusion criteria
Exclusion criteria: 1Known or suspected hypersensitivity to trial product(s) or related products. 2Previous participation in this trial. Participation is defined as signed informed consent. 3Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). 4Receipt of any investigational medicinal product within 90 days before screening. 5Any disorder, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol. 6Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). 7History of pancreatitis (acute or chronic). 8History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). 9Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation. 10Classified as being in New York Heart Association (NYHA) Class IV. 11Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. 12Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) 13Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term change of insulin treatment for acute illness for a total of 14Known hypoglycaemic unawareness according to Clarkeâ??s questionnaire. 15Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation. 16History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ). 17Subjects with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c Timepoint: Week 0 to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| If a subject after week 26 and week 52 achieves HbA1c 7.0% (53 mmol/mol)Timepoint: Week 0 till after week 26 and week 52;Change from baseline to week 26 and week 52 in: 1Fasting plasma glucose (FPG)Timepoint: Week 0 to week 26 and week 52;Change from baseline to week 26 in body weightTimepoint: Week 0 to week 26;Change from baseline to week 52 in: 1HbA1c 2Body weight (kg)Timepoint: Week 0 to week 52;Number of treatment-emergent adverse events (TEAEs) and Systamatic Hypoglycaemic episodes during exposure to trial product, assessed up to approximately 57 weeksTimepoint: Week 0 to week 57 | — |
Countries
Canada, France, Greece, India, Japan, Mexico, Poland, Russian Federation, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed