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: - Male or female, age greater than or equal to 18 years at the time of signing informed consent - Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening - Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening - Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors - Haemoglobin A1c (HbA1c) of greater than 7.5% to less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol) 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 1430 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 613
Exclusion criteria
Exclusion criteria: - History or presence of pancreatitis (acute or chronic) - 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 Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to run-in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of semaglutide once-weekly on glycaemic control versus insulin aspart three times daily, both as add on to metformin and optimised insulin glargine (U100) in subjects with type 2 diabetes.;Secondary Objective: 1. To demonstrate that semaglutide once-weekly lowers the risk of severe hypoglycaemic episodes compared to insulin aspart three times daily, both as add on to metformin and optimised insulin glargine (U100) in subjects with type 2 diabetes. 2. To compare the effect of semaglutide once-weekly versus insulin aspart three times daily, both as add on to metformin and optimised insulin glargine (U100) in subjects with type 2 diabetes with regards to: -body weight -lipids -blood pressure -health-related quality of life -safety;Primary end point(s): Change in HbA1c (%-point);Timepoint(s) of evaluation of this end point: From baseline to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to first event adjudication committee confirmed severe hypoglycaemic episode (American Diabetes Association) 2. Time to first event adjudication committee confirmed severe hypoglycaemic episode (American Diabetes Association) requiring hospitalisation, documented medical help, or is life threatening 3. Change in body weight (kg);Timepoint(s) of evaluation of this end point: 1-2. From randomisation up to week 52 3. From baseline to week 52 | — |
Countries
Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, European Union, Germany, Greece, Hungary, India, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Poland, Portugal, Serbia, Slovakia, Slovenia, South Africa, Spain, Turkey
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed