Diabetes Mellitus, Type 2 MedDRA version: 20.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000072461
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main phase (the inclusion criteria for the main phase are not reassessed for the extension phase): 1. Informed 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. 2. Male or female, age above or equal to 18 years at the time of signing informed consent. For Korea only: Male or female, age above or equal to 19 years at the time of signing informed consent. 3. Diagnosed with type 2 diabetes mellitus = 90 days prior to day of screening. 4. HbA1c 7.5-9.5% (58-80 mmol/mol) (both inclusive). 5. Treatment target of HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: Main phase (the exclusion criteria for the main phase are not reassessed for the extension phase): 1. Female 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). For certain specific countries: Additional specific requirements apply. 2. Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol. 3. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma. 4. History of pancreatitis (acute or chronic). 5. 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). 6. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation. 7. Subjects presently classified as being in New York Heart Association Class IV. 8. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. 9. Subjects with alanine aminotransferase > 2.5 x upper normal limit. 10. Renal impairment defined as Estimated Glomerular Filtration rate < 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula. 11. Treatment 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 insulin treatment for acute illness for a total of = 14 days. 12. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation. 13. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ). 14. History of diabetic ketoacidosis. Extension phase: There are no new exclusion criteria for the extension phase.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Main phase: Glycosylated haemoglobin (HbA1c) < 7% (53 mmol/mol) American Diabetes Association target (yes/no) ;Timepoint(s) of evaluation of this end point: After week 52;Main Objective: Main phase: To compare the effect of once-daily dosing of oral semaglutide using a flexible dose adjustment based on clinical evaluation versus sitagliptin once-daily, both in combination with 1-2 oral antidiabetic drugs (OADs) on glycaemic control in subjects with Type 2 diabetes mellitus (T2DM).; Secondary Objective: Main phase To compare - the effect on body weight - the safety and tolerability of once-daily dosing of oral semaglutide using a flexible dose adjustment based on clinical evaluation versus sitagliptin once daily, both in combination with 1-2 OADs in subjects with T2DM. Extension phase (sustainability) To evaluate - the sustainability of glycaemic control and body weight reduction - the long term safety of once-daily dosing of oral semaglutide using a flexible dose adjustment based on clinical evaluation in subjects with T2DM. Extension phase (switch) To compare - the effect on glycaemic control - the effect on body weight - the safety and tolerability of switching to once-daily dosing of oral semaglutide using a flexible dose adjustment based on clinical evaluation versus staying on oncedaily sitagliptin in subjects with T2DM. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Main phase: 1.-3. From baseline to week 52 4.+ 5. Assessed up to approximately 52 weeks Ext phase (sustainability) 1.: After week 104 2. – 4.: From baseline to week 104 5. – 6.: Assessed up to approximately 109 weeks Ext phase (switch) 7.: After week 104 8. – 10.: From week 52 to 104 11. – 12.: Assessed from week 52 up to approximately 109 weeks ; Secondary end point(s): Main phase: 1. Change in body weight (kg) 2. Change in HbA1c 3. Change in fasting plasma glucose 4. Number of treatment-emergent adverse events during exposure to trial product 5. Number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes during exposure to trial product Ext phase (sustainability): 1. If a subject achieves (yes/no) HbA1c < 7% (53 mmol/mol) American Diabetes Association target. 2. Change in body weight (kg) 3. Change in HbA1c 4. Change in fasting plasma glucose (FPG) 5. Number of treatment-emergent adverse events during exposure to trial product, 6. Number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes during exposure to trial product Ext phase (switch): 7. If a subject achieves (yes/no) HbA1c < 7% (53 mmol/mol) American Diabetes Association target. 8. Change in body weight (kg) 9. Change in HbA1c 10. Change in fasting plasma glucose (FPG) 11. Number of treatment-emergent adverse events during exposure to trial product 12. Number of treatment-eme | — |
Countries
Argentina, Austria, Belgium, Brazil, Egypt, European Union, Korea, Republic of, Norway, Switzerland, Turkey, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed