Diabetes Mellitus, Type 2 MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, age = 18 years at the time of signing informed consent. For Japan only: Male or female, age = 20 years at the time of signing informed consent. 2. Diagnosed with T2DM = 90 days prior to day of screening. 3. HbA1c 7.0-10.5 % (53-91 mmol/mol) (both inclusive). 4. Stable daily dose of metformin (= 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the day of screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1395 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 465
Exclusion criteria
Exclusion criteria: 1. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). For certain specific countries: Additional specific requirements apply. 2. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). 3. History of pancreatitis (acute or chronic). 4. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). 5. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening. 6. Subjects presently classified as being in New York Heart Association (NYHA) Class IV. 7. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. 8. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). 9. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of once-daily dosing of three dose levels (3 mg, 7 mg and 14 mg) of oral semaglutide versus sitagliptin 100 mg once-daily, both in combination with metformin with or without sulfonylurea (SU), on glycaemic control in subjects with type 2 diabetes mellitus (T2DM);Secondary Objective: 1. To compare the effect of once-daily dosing of three dose levels (3 mg, 7 mg and 14 mg) of oral semaglutide versus sitagliptin 100 mg once-daily, both in combination with metformin with or without SU, on body weight in subjects with T2DM. 2. To compare the long-term safety and tolerability of once-daily dosing of three dose levels (3 mg, 7 mg and 14 mg) of oral semaglutide versus sitagliptin 100 mg once-daily, both in combination with metformin with or without SU, in subjects with T2DM. ;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in: 1. Body weight (kg) 2. Fasting plasma glucose (FPG) Subjects who achieve (yes/no): 3.HbA1c < 7.0% (53 mmol/mol), American Diabetes Association (ADA) target Change in: 4. HbA1c 5. Body weight (kg) 6. FPG 7. Number of treatment emergent adverse events (TEAEs) during exposure to trial product 8. Number of treatment emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product;Timepoint(s) of evaluation of this end point: 1. + 2.: From baseline to week 26 3.: After 26 weeks, 52 weeks and 78 weeks of treatment 4. + 5. + 6.: From baseline to week 52 and to week 78 7. + 8.: Assessed up to approximately 83 weeks | — |
Countries
Argentina, Brazil, European Union, Germany, India, Israel, Japan, Mexico, Russian Federation, South Africa, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed