Type 2 diabetes MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Product Name: NN5401
Product Code: NN5401
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin degludec
Current Sponsor code: NNC 0100-0000-0454
Concentration unit: U/ml unit(s)/mi
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 procedure that would not have been performed during normal management of the subject.) • Male or female = 18 years of age • Type 2 diabetes mellitus (diagnosed clinically) for = 6 months • HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis • BMI = 40.0 kg/m^2 • Insulin naïve subjects (Allowed are: Previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days) • Ongoing treatment with: Metformin with or without other OAD for at least 3 months prior to randomisation with the minimum metformin dose of 1500 mg daily or maximum tolerated dose (at least 1000 mg daily). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors • Use within 3 months prior to Visit 1 of GLP-1 receptor agonist and/or TZDs Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA)3 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of insulin degludec/insulin aspart OD + metformin in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c after 26 weeks of treatment between insulin degludec/insulin aspart OD + metformin and insulin glargine + metformin to a noninferiority limit of 0.4%, and if non-inferiority is confirmed to a superiority limit of 0%.;Secondary Objective: To confirm superiority of insulin degludec/insulin aspart OD + metformin to insulin glargine OD + metformin after 26 weeks of treatment in terms of: • prandial plasma glucose (PG) increment at breakfast • frequency of responders for HbA1c (<7.0%) without severe and minor hypoglycaemic episodes • nocturnal hypoglycaemic episodes (severe and minor) • body weight To compare efficacy and safety after 26 weeks of treatment in terms of: • fasting plasma glucose (FPG) from central laboratory • 9-point profile (SMPG) • self measured PG for dose adjustments • frequency of responders for HbA1c targets • adverse events • hypoglycaemic episodes • clinical and laboratory assessments • insulin dose • body weight • insulin antibodies • patient reported outcome (PRO).;Primary end point(s): Change from baseline in HbA1c (%) after 26 weeks of treatment. | — |
Countries
Poland
Outcome results
None listed