Diabetes Mellitus, Type 2 MedDRA version: 20.1 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 at the time of signing informed consent. - Diagnosed with type 2 diabetes = 10 years prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen = 1 year prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1). Randomisation criterion: - HbA1c = 9.0% measured by the central laboratory at Visit 13 (week -1). 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 965 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 107
Exclusion criteria
Exclusion criteria: - 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 (Visit 1). - 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 (Visit 1). - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the effect in terms of glycaemic control of treatment with fast-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen, using a non-inferiority approach.; Secondary Objective: 1. To confirm superiority of fast-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen in terms of: - Postprandial glucose regulation - Overall glycaemic control - Postprandial glucose excursions 2. To compare the safety of fast-acting insulin aspart to NovoRapid® both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen. ;Primary end point(s): Change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: 16 weeks after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in 1-hour postprandial glucose increment (meal test) 2. Change from baseline in 1,5-anhydroglucitol ;Timepoint(s) of evaluation of this end point: 1.-2. 16 weeks after randomisation | — |
Countries
Argentina, Bulgaria, Canada, Croatia, Czech Republic, European Union, Germany, Greece, Korea, Republic of, Russian Federation, Serbia, Spain, Ukraine, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed