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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
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin degludec
Drug: insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 24
Study Start Date: April 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg Drug: insulin degludec
Administered subcutaneously (s.c., under the skin) once daily.
Active Comparator: IGlar Drug: insulin glargine
Administered subcutaneously (s.c., under the skin) once daily.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569841

Locations
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, United States, 55416-2699
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01569841     History of Changes
Other Study ID Numbers: NN1250-3874  U1111-1125-7495 
Study First Received: March 30, 2012
Results First Received: October 16, 2015
Last Updated: January 21, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016