Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT01831765
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1290
- Type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m^2
- Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meal time FIAsp and insulin detemir Faster-acting insulin aspart - Meal time insulin aspart and insulin detemir insulin aspart - Post meal FIAsp and insulin detemir Faster-acting insulin aspart - Meal time FIAsp and insulin detemir insulin detemir - Meal time insulin aspart and insulin detemir insulin detemir - Post meal FIAsp and insulin detemir insulin detemir -
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c (Glycosylated Haemoglobin) Week 0, week 26 Change from baseline in HbA1c after 26 weeks of randomised treatment.
- Secondary Outcome Measures
Name Time Method Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) Week 0, week 26 Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test).
Change From Baseline in HbA1c (Post Meal Arm) Week 0, week 26 Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes From baseline until week 26 Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value \<3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.
Change From Baseline in Body Weight Week 0, week 26 Change from baseline in body weight after 26 weeks of randomised treatment.
Frequency of Adverse Events After 52 weeks of randomised treatment All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment.
Change in HbA1c Week 0, week 52 Change from baseline in HbA1c (%) after 52 weeks of randomised treatment.
Change in PPG (Postprandial Glucose) Week 0, week 52 Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment.
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Sheffield, United Kingdom