Diabetes Mellitus, Type 2 MedDRA version: 16.0 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: • Female or male, age = 18 years at the time of signing inform consent • Type 2 diabetes (diagnosed clinically) = 6 months at time of screening (visit 1) • Treated with basal insulin for at least 6 months prior to screening (visit 1) • Current once daily treatment with insulin NPH, insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1) • Current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (SU) or glinide or DPP-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg • HbA1c by central laboratory: a. 7.0 - 9.5% (53 – 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 – 75 mmol/mol) (both inclusive) in the metformin + other OAD (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1) • Body mass index (BMI) = 40.0 kg/m^2 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 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 276
Exclusion criteria
Exclusion criteria: • Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1) • Use of GLP-1 agonists and/or TZDs within the last 3 months prior to screening (visit 1) • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1) • Cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as: stroke, decompensated heart failure New York Heart Association (NYHA) 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 efficacy of treatment with meal time faster-acting insulin aspart (FIAsp) in terms of glycaemic control measured by glycosylated haemoglobin (HbA1c) after 26 weeks of randomised treatment, by comparing to meal time insulin aspart, both in combination with once daily insulin glargine and metformin, using a non-inferiority approach.;Secondary Objective: 1. To confirm superiority of meal time FIAsp vs. meal time insulin aspart both in combination with once daily insulin glargine and metformin after 26 weeks of randomised treatment in terms of: • Postprandial glucose (PPG) regulation • Number of hypoglycaemic episodes • Body weight regulation 2. To compare other efficacy and safety endpoints of meal time FIAsp with meal time insulin aspart, both in combination with once daily insulin glargine and metformin, after 26 weeks of randomised treatment;Primary end point(s): Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: After 26 weeks of randomised treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in 2-hour PPG increment (meal test) 2. Number of treatment emergent confirmed hypoglycaemic episodes 3. Change from baseline in body weight ;Timepoint(s) of evaluation of this end point: 1. After 26 weeks of randomised treatment 2. From baseline to 26 weeks of randomised treatment 3. After 26 weeks of randomised treatment | — |
Countries
Canada, Croatia, European Union, India, Israel, Russian Federation, Serbia, Slovakia, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed