Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01002768
First received: October 26, 2009
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.

The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration [ Time Frame: Within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose [ Time Frame: Within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]
  • Time from start of hypoglycaemic induction until each level of plasma glucose is reached [ Time Frame: Within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]
  • Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L [ Time Frame: Within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]
  • Hypoglycaemic symptoms score during recovery from hypoglycaemia [ Time Frame: Within 0-46 hours after last trial product administration ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg Drug: insulin degludec
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
Experimental: IGlar Drug: insulin glargine
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 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: NCT01002768

Locations
Austria
Graz, Austria, 8010
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01002768     History of Changes
Other Study ID Numbers: NN1250-3538, U1111-1111-8843, 2008-008356-16
Study First Received: October 26, 2009
Last Updated: November 26, 2013
Health Authority: Austria: Agency for Health and Food Safety

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
Glargine
Insulin
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014