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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: December 19, 2012
Last verified: December 2012
  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: 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 ]

Secondary Outcome Measures:
  • 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 ]

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
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: Iben Turi Sjöberg Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

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
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014