type 1 diabetes MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Name: SIBA (D)
Product Code: NN1250
Pharmaceutical Form: Solution for injection
Current Sponsor code: Insulin 454
Concentration unit: mmol/l millimole(s)/litre
Concentration type: equal
Concen
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Type 1 diabetes mellitus (diagnosed = 12 months) • Male or female, 18-75 (both inclusive) • HbA1c 7-11 % (both inclusive) • Treated with insulin = 6 months – any regimen 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: • Any systemic treatment with products which in the Investigator’s opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 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 HbA1c after 16 weeks of treatment with SIBA (D) QD + NovoRapid® or SIBA (E) QD + NovoRapid® compared with that of insulin glargine QD + NovoRapid®, all in a basal/bolus regimen, in subjects with type 1 diabetes.;Secondary Objective: 1. To compare efficacy and safety after 16 weeks of treatment in terms: - body weight - 9-point plasma glucose profiles - lipid profiles - frequency of hypoglycaemic episodes - waist and hip circumference 2. To compare intra-subject variability based on self measured plasma glucose 3. To compare patient reported outcome;Primary end point(s): • HbA1c after 16 weeks of treatment | — |
Countries
Germany, Sweden
Outcome results
None listed