type 2 diabetes mellitus 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 months at a stable maximally tolerated dose or at least half maximally 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) treatment within previous 3 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 (except for conditions associated with type 2 diabetes) 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) BID or NovoMix®30 BID, all in combination with metformin, in subjects with type 2 diabetes, failing on OAD treatment.;Secondary Objective: •To investigate the timing and the extent of blood glucose excursions, measured by continuous glucose measurement (CGM) after 8 and 16 weeks •To compare plasma glucose profiles obtained at meal test after 16 weeks of treatment •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 and insulin aspart •To assess and compare patient reported outcome ;Primary end point(s): HbA1c after 16 weeks of treatment | — |
Countries
Finland, France, Germany, Spain
Outcome results
None listed