A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT01569841
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Type 1 diabetes
- HbA1c (glycosylated haemoglobin) below or equal to 8.5%
- Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
- BMI (body mass index) below 35 kg/m^2
- Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
- Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
- Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
- Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IGlar insulin glargine - IDeg insulin degludec -
- Primary Outcome Measures
Name Time Method Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL) CGM occured during the last 2 weeks of the 6 weeks treatment period. Time within the glycaemic target range \[\> 70 mg/dL (3.9 mmol/L) and \< 130 mg/dL (7.2 mmol/L)\] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.
- Secondary Outcome Measures
Name Time Method Glycosylated Haemoglobin (HbA1c) At the end of each 6 week treatment period. HbA1c after 6 weeks of treatment in each treatment period.
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes Hypoglycemic episodes reported within each 6 week treatment period. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.
Mean Interstitial Glucose (IG) Based on 14 Days of CGM CGM monitoring occurred during the last 2 weeks of the 6-week treatment period. The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period.
Fasting Plasma Glucose (FPG) At the end of each 6 week treatment period. FPG after 6 weeks of treatment in each treatment period.
Number of Treatment Emergent Adverse Events (AEs) Within each week 6 treatment period Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.
Trial Locations
- Locations (1)
Novo Nordisk Clinical Trial Call Center
🇺🇸Minneapolis, Minnesota, United States