| Trial ID: | L4240 |
| Source ID: | NCT01569841
|
| Associated Drug: |
Insulin Degludec
|
| Title: |
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01569841/results
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: insulin degludec|DRUG: insulin glargine
|
| Outcome Measures: |
Primary: Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL), 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., CGM occured during the last 2 weeks of the 6 weeks treatment period. | Secondary: Mean Interstitial Glucose (IG) Based on 14 Days of CGM, 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., CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.|Fasting Plasma Glucose (FPG), FPG after 6 weeks of treatment in each treatment period., At the end of each 6 week treatment period.|Glycosylated Haemoglobin (HbA1c), HbA1c after 6 weeks of treatment in each treatment period., At the end of each 6 week treatment period.|Number of Treatment Emergent Adverse Events (AEs), 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., Within each week 6 treatment period|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes, 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., Hypoglycemic episodes reported within each 6 week treatment period.
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
|
| Enrollment: |
24
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-04
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| Completion Date: |
2012-11
|
| Results First Posted: |
2015-11-17
|
| Last Update Posted: |
2016-02-18
|
| Locations: |
Novo Nordisk Clinical Trial Call Center, Minneapolis, Minnesota, 55416-2699, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01569841
|
