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: December 19, 2012
Last verified: December 2012

March 30, 2012
December 19, 2012
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: 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 ]
Same as current
Complete list of historical versions of study NCT01569841 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01569841
NN1250-3874, U1111-1125-7495
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Iben Turi Sjöberg Novo Nordisk A/S
Novo Nordisk A/S
December 2012

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