Diabetes Mellitus Tipo 2 MedDRA version: 9.1 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 any procedure that would not have been performed during normal management of the subject.) •Insulin naïve type 2 diabetes subjects (as diagnosed clinically) = 3 months (no previous insulin treatment or previous short term insulin treatment = 14 days within the last 3 months) •Treatment with one or two OADs: metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), a-glucosidase inhibitors for at least 2 month at a stable maximum tolerated dose or at least half maximum allowed dose according to locally approved SPC. •Male or female, age 18-75 years (both inclusive) •HbA_1c, 7.0 - 11.0 % (both inclusive) •BMI, 25.0 - 37.0 kg/m^2 (both inclusive) 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: •Metformin contraindication according to local practice •Thiazolidinedione (TZD) treatments within the previous three months prior to visit 1 •Any systemic treatment with products, which in the investigator’s opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation •Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess glucose control with respect to HbA_1c after 16 weeks of treatment with SIAC 30 (B) or SIAC 45 (B) QD or insulin glargine QD, all in combination with metformin, in subjects with type 2 diabetes mellitus, failing on OAD treatment.;Secondary Objective: Between the treatment arms: •To investigate the timing and the extent of blood glucose excursions, measured by continuous glucose measurement (CGM) after 8 and 16 weeks •To compare efficacy and safety after 16 weeks of treatment in terms of: -9-point plasma glucose profile -Lipid profile -Hypoglycaemic episodes and adverse events -Body weight -Waist and hip circumference •To compare intra-subject variability in self measured plasma glucose •To assess pharmacokinetic (PK) for insulin 454 •To assess and compare patient reported outcome ;Primary end point(s): •HbA1c after 16 weeks of treatment | — |
Countries
France, Germany, Spain
Outcome results
None listed