Diabetes Mellitus, Type 2 MedDRA version: 21.1 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: - 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 - Male or female, age above or equal to 18 years at the time of signing informed consent. For Algeria only: Male or female, age above or equal to 19 years at the time of signing informed consent. For Taiwan only: Male or female, age above or equal to 20 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus above or equal to 60 days prior to day of screening - Glycosylated haemoglobin (HbA1c) between 7.0-10.5% (53-91 mmol/mol) (both inclusive) - Stable daily dose of metformin (more than or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) above or equal to 60 days prior to 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 1083 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 361
Exclusion criteria
Exclusion criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measure as required by local regulation or practice) - Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - 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) - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) - Subjects with alanine aminotransferase (ALT) more than 2.5 x upper limit of the normal (ULN) - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Fundus examination without dilation is only allowed if the digital camera used for fundus photography has this feature - Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of three once-daily dose levels of oral semaglutide (3, 7 and 14 mg) versus sitagliptin 100 mg once-daily, both in combination with metformin, on glycaemic control in subjects with type 2 diabetes mellitus (T2D).;Secondary Objective: 1. To compare the effect of three once-daily dose levels of oral semaglutide (3, 7 and 14 mg) versus sitagliptin 100 mg once-daily, both in combination with metformin, on body weight in subjects with T2D. 2. To compare the safety and tolerability of three once-daily dose levels of oral semaglutide (3, 7 and 14 mg) versus sitagliptin 100 mg once-daily, both in combination with metformin, in subjects with T2D.;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): 1. Change in body weight 2. Change in fasting plasma glucose 3. If a subject achieves (yes/no) HbA1c <7.0 % (53 mmol/mol) (American Diabetes Association target) 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;Timepoint(s) of evaluation of this end point: 1. and 2. From baseline to week 26 3. After week 26 4. and 5. Assessed up to approximately 31 weeks | — |
Countries
Algeria, Brazil, China, Czech Republic, European Union, Hong Kong, Romania, Serbia, South Africa, Taiwan
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed