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: • Insulin naïve subject (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). • Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor, a-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: - Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily) - Insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling - DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling - a-glucosidase-inhibitors (Acarbose): minimum half of the daily maximal dose or maximum tolerated dose • HbA_1c 7.0-10.0 % (both inclusive) by central laboratory analysis • BMI = 45.0 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: • Use within the last 3 months prior to Visit 1 of: thiazoledinediones (TZDs), exenatide or liraglutide • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period • Known or suspected allergy to any of the trial products or related products • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of SIBA 200 U/ml once daily + metformin ± DPP-4 inhibitor in controlling glycaemia with respect to change from baseline in HbA_1c after 26 weeks of treatment. This is done by comparing the difference in change from baseline in HbA_1c after 26 weeks of treatment between SIBA 200 U/ml once daily + metformin ± DPP-4 inhibitor and insulin glargine once daily + metformin ± DPP-4 inhibitor 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 SIBA 200 U/ml once daily + metformin ± DPP-4 inhibitor over insulin glargine once daily + metformin ± DPP-4 inhibitor after 26 weeks of treatment in terms of: • Treatment emergent severe or minor hypoglycaemic episodes • Fasting plasma glucose (FPG) analysed at a central laboratory • Within-subject variability in pre-breakfast self-measured plasma glucose (SMPG) • Frequency of responders for HbA_1c (< 7.0%) without hypoglycaemic episodes To compare efficacy and safety in terms of: • 9-point profile self measured plasma glucose (SMPG) • 1-point profile (SMPG) for dose adjustments • Frequency of responders for HbA_1c • Adverse events • Hypoglycaemic episodes • Clinical and laboratory assessments • Insulin antibodies • Insulin dose • Body weight • Patient reported outcome (PRO) ;Primary end point(s): • Change from baseline in HbA_1c after 26 weeks of treatment • Change from baseline in FPG after 26 weeks of treatment • Within-subject variability in pre-breakfast self-measured plasma glucose (SMPG) after 26 weeks of treatment • Responder without hypoglycaemic episodes (HbA_1c <7.0%) at end of trial without severe or minor hypoglycaemic episodes | — |
Countries
France, Ireland, United Kingdom
Outcome results
None listed