Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT00612040
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
- Type 1 diabetes for at least one year
- HbA1c 7-11% (both inclusive)
- Treated with insulin for at least six months - any regimen
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SIBA (D) insulin aspart - IGlar insulin aspart - SIBA (E) insulin degludec - SIBA (E) insulin aspart - SIBA (D) insulin degludec - IGlar insulin glargine -
- Primary Outcome Measures
Name Time Method Change in Glycosylated Haemoglobin (HbA1c) Week 0, Week 16 Change from baseline in HbA1c after 16 weeks of treatment
- Secondary Outcome Measures
Name Time Method Change in Fasting Plasma Glucose (FPG) Week 0, Week 16 Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) Week 16 Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Rate of Major and Minor Hypoglycaemic Episodes Week 0 to Week 16 + 5 days follow up Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes Week 0 to Week 16 + 5 days follow up Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).
Rate of Treatment Emergent Adverse Events (AEs) Week 0 to Week 16 + 5 days follow up Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) Week -1, Week 16 Laboratory values at screening (Week -1) and at Week 16
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) Week -1, Week 16 Laboratory values at screening (Week -1) and at Week 16
Laboratory Safety Parameters (Biochemistry): Serum Creatinine Week -1, Week 16 Laboratory values at screening (Week -1) and at Week 16
Vital Signs: Diastolic BP (Blood Pressure) Week 0, Week 16 Values at baseline (Week 0) and at Week 16
Vital Signs: Systolic BP (Blood Pressure) Week 0, Week 16 Values at baseline (Week 0) and at Week 16
Vital Signs: Pulse Week 0, Week 16 Values at baseline (Week 0) and at Week 16
Physical Examination Week -1, Week 8, Week 16 Physical examination was performed at screening (week -1), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇪Umeå, Sweden