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 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) • Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, a-glucosidase-inhibitor (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 (SU) 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-inhibitor (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 •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 •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of SIBA 200 U/ml three times weekly + metformin ± DPP-4 inhibitor 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 SIBA 200 U/ml three times weekly + metformin ± DPP-4 inhibitor and insulin glargine once daily (OD) + 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 three times weekly + metformin ± DPP-4 inhibitor over insulin glargine OD + metformin ± DPP-4 inhibitor after 26 weeks of treatment in terms of: •Change from baseline in body weight To compare efficacy and safety in terms of: •Frequency of responders for HbA1c •FPG (analysed by central laboratory) •9-point profile (SMPG) •1-point profile (SMPG) for dose adjustments •Adverse events •Hypoglycaemic episodes •Clinical and laboratory assessments •Insulin dose •Patient reported outcome ;Primary end point(s): Change from baseline in HbA1c after 26 weeks of treatment (analysed by central laboratory). | — |
Countries
Bulgaria, France, Hungary, Netherlands
Outcome results
None listed