Diabetes Mellitus, Type 2 MedDRA version: 14.1 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: • Age =18 years at time the informed consent is signed by the Subject (Visit 1) • Type 2 diabetes (diagnosed clinically) = 6 months prior to the screening visit (Visit 1) • Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH 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 Dipeptidyl peptidase-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) 7.5-9.5% (58 – 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 – 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 118 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Any use of bolus insulin, except short-term use due to intermittent illness (no longer than14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1) • Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1) • Recurrent severe hypoglycaemia (more than one 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superiority of meal-time Faster-acting insulin aspart (FIAsp) in a full basal-bolus regimen versus basal insulin therapy, both in combination with metformin, in terms of glycaemic control after 18-weeks of randomised treatment;Secondary Objective: • To compare meal-time FIAsp in a full basal bolus regimen versus basal insulin therapy, both in combination with metformin, in terms of postprandial glucose (PPG) regulation after 18 weeks of randomised treatment • To compare other efficacy and safety endpoints of meal-time FIAsp in a full basal bolus regimen versus basal insulin therapy, both in combination with metformin, after 18 weeks of randomised treatment ;Primary end point(s): • Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: After 18 weeks of randomised treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Self-measured plasma glucose (SMPG) 7- point profile a. Post prandial plasma glucose (PPG), overall 2-hour mean (of breakfast, lunch, main evening meal) b. Prandial plasma glucose (PG) increment, overall 2-hour mean (of breakfast, lunch, main evening meal) 2. Change from baseline in body weight 3. Number of treatment emergent hypoglycaemic episodes 4. Number of adverse events ;Timepoint(s) of evaluation of this end point: 1.-2. After 18 weeks of randomised treatment 3.-4. During 18 weeks of randomised treatment | — |
Countries
Argentina, India, Mexico, Romania, Slovenia, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed