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 18 years or older at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus 180 days or longer prior to the day of screening. - The need and willingness to change prior GLP-1 RA treatment to once-weekly semaglutide s.c., as assessed by the investigator. - HbA1c of 6.5-10% (48-86 mmol/mol) (both inclusive). - Treatment with any therapeutic dose of GLP-1 RA other than once-weekly semaglutide s.c., as defined in the local label, with or without OADs (metformin, DPP-4 inhibitor, SU, glinide, thiazolidinedione, SGLT-2 inhibitor or alpha-glucosidase inhibitor). All doses of antidiabetic treatments should have been stable for at least 90 days prior to the day of the screening, at investigator’s discretion. 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - 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 insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes. - Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by KDIGO 2012 classification. - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of starting at a 0.5 mg dose versus a 0.25 mg dose of once-weekly semaglutide s.c. on glycaemic control in subjects with T2D previously treated with GLP-1 RAs with or without OADs.;Secondary Objective: 1. To compare starting at a 0.5 mg dose versus a 0.25 mg dose of once-weekly semaglutide s.c. in subjects with T2D previously treated with GLP-1 RAs with or without OADs on: - General safety and tolerability - Effect on body weight 2. To evaluate the use of the new once-weekly semaglutide s.c. single-dose pen-injector at the 2.0 mg dose level in subjects with T2D previously treated with GLP-1 RAs with or without OADs.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline (week 0) to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in fasting plasma glucose 2. Change in body weight 3. Number of treatment emergent adverse events (TEAEs) 4. Number of treatment emergent gastrointestinal adverse events 5. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes 6. Change in pulse rate 7. Number of treatment emergent adverse events (TEAEs);Timepoint(s) of evaluation of this end point: 1.-6.: From baseline (week 0) to week 12 7.: From week 12 to week 17 | — |
Countries
Austria, European Union, Finland, Sweden, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed