Diabetes Mellitus, Type 2 MedDRA version: 19.1 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: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus. - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive). - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin equal to or above 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (equal to or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) SGLT-2 inhibitors (equal to or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). 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 470 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 106
Exclusion criteria
Exclusion criteria: - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative. - History or presence of pancreatitis (acute or chronic). - History of diabetic ketoacidosis. - 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. - 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) value of less than 30 ml/min/1.73 m^2 as defined by KDIGO 2012 classification. - Impaired liver function, defined as ALT equal to or above 2.5 times upper normal limit at screening. - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of semaglutide subcutaneous (s.c.) 1.0 mg once-weekly versus liraglutide s.c. 1.2 mg once-daily on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes.;Secondary Objective: To compare the effects of semaglutide s.c. 1.0 mg once-weekly versus liraglutide s.c. 1.2 mg once-daily after 30 weeks of treatment on body weight, efficacy parameters, safety and tolerability in subjects with type 2 diabetes.;Primary end point(s): Change in HbA1c.;Timepoint(s) of evaluation of this end point: From baseline to week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in body weight (kg) 2. Change in fasting plasma glucose (FPG) 3. Change in systolic and diastolic blood pressure;Timepoint(s) of evaluation of this end point: 1.-3. From baseline to week 30 | — |
Countries
Bulgaria, Czech Republic, European Union, Finland, France, Hungary, Italy, Poland, Slovenia, Spain, Sweden, United Kingdom
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed