type 2 diabetes mellitus MedDRA version: 12.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
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 defined as any procedures that would not have been performed during standard management of the subject). • Male or female = 18 years of age • Type 2 diabetes mellitus (diagnosed clinically) for = 6 months • Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn [NPH] insulin) OD, for at least 3 months • Ongoing treatment with: metformin with or without other OADs for at least 3 months prior to randomisation • HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis • BMI = 40.0 kg/m² 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: • Treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1 • Total daily insulin dose above 1 U/kg • Treatment with glucagon-like peptide 1(GLP-1) receptor agonists within 3 months prior to visit 1 • Current rosiglitazone users • Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits • Cardiovascular disease, within the last 6 months prior to 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 the efficacy of SIAC OD + metformin ± pioglitazone ± DPP-4 inhibitors 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 between SIAC OD + metformin ± pioglitazone ± DPP-4 inhibitors and insulin glargine OD + metformin ± pioglitazone ± DPP-4 inhibitors to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%. ;Secondary Objective: To confirm superiority of SIAC OD + metformin ± pioglitazone ± DPP-4 inhibitors over insulin glargine + metformin ± pioglitazone ± DPP-4 inhibitors after 26 weeks of treatment in terms of • Prandial plasma glucose (PG) increment • Frequency of responders for HbA1c (<7%) without hypoglycaemic episodes • Fluctuation in nocturnal interstitial glucose (IG) • Nocturnal hypoglycaemic episodes • Body weight To compare efficacy and safety after 26 weeks of treatment in terms of: • Fasting plasma glucose (FPG) from central laboratory • 9-point self measured plasma glucose (SMPG) profile • SMPG for dose adjustments • Frequency of responders for HbA1c • Glucose profile as measured with CGM in a sub-population • Insulin dose • Adverse events • Hypoglycaemic episodes • Clinical and laboratory assessments • Patient reported outcome ;Primary end point(s): Change from baseline in HbA1c after 26 weeks of treatment (analysed by central laboratory) | — |
Countries
France, Poland, Sweden
Outcome results
None listed