A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01569841
First received: March 30, 2012
Last updated: January 21, 2016
Last verified: January 2016

March 30, 2012
January 21, 2016
April 2012
November 2012   (final data collection date for primary outcome measure)
Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL) [ Time Frame: CGM occured during the last 2 weeks of the 6 weeks treatment period. ] [ Designated as safety issue: No ]
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.
Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL) [ Time Frame: In the last four hours of each dosing interval during 14 days of CGM (Continuous Glucose Monitoring) usage in the last 2 weeks of the 6 weeks treatment period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01569841 on ClinicalTrials.gov Archive Site
  • Mean Interstitial Glucose (IG) Based on 14 Days of CGM [ Time Frame: CGM monitoring occurred during the last 2 weeks of the 6-week treatment period. ] [ Designated as safety issue: No ]
    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) [ Time Frame: At the end of each 6 week treatment period. ] [ Designated as safety issue: No ]
    FPG after 6 weeks of treatment in each treatment period.
  • Glycosylated Haemoglobin (HbA1c) [ Time Frame: At the end of each 6 week treatment period. ] [ Designated as safety issue: No ]
    HbA1c after 6 weeks of treatment in each treatment period.
  • Number of Treatment Emergent Adverse Events (AEs) [ Time Frame: Within each week 6 treatment period ] [ Designated as safety issue: No ]
    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.
  • Number of Treatment Emergent Confirmed Hypoglycaemic Episodes [ Time Frame: Hypoglycemic episodes reported within each 6 week treatment period. ] [ Designated as safety issue: No ]
    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 IG (Interstitial Glucose) based on 14 days of CGM [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose (FPG) [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of treatment emergent AEs (adverse events) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Number of treatment emergent hypoglycaemic episodes [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin degludec
    Administered subcutaneously (s.c., under the skin) once daily.
  • Drug: insulin glargine
    Administered subcutaneously (s.c., under the skin) once daily.
  • Experimental: IDeg
    Intervention: Drug: insulin degludec
  • Active Comparator: IGlar
    Intervention: Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01569841
NN1250-3874, U1111-1125-7495
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP