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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01002768
First Posted: October 27, 2009
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

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 ]
  • 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 ]
  • 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 ]
  • Hypoglycaemic symptoms score during recovery from hypoglycaemia [ Time Frame: Within 0-46 hours after last trial product administration ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002768


Locations
Austria
Novo Nordisk Investigational Site
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:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01002768     History of Changes
Other Study ID Numbers: NN1250-3538
U1111-1111-8843 ( Other Identifier: WHO )
2008-008356-16 ( EudraCT Number )
First Submitted: October 26, 2009
First Posted: October 27, 2009
Last Update Posted: January 20, 2017
Last Verified: January 2017

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
Hypoglycemic Agents
Physiological Effects of Drugs