Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01076634
First received: February 24, 2010
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin degludec
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 Pharmacodynamic Properties of 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:
  • Area under the glucose infusion rate curve during one dosing interval at steady-date" [ Time Frame: After 8 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the serum Insulin Degludec concentration-time curve [ Time Frame: During one dosing interval at steady state ] [ Designated as safety issue: No ]
  • Area under the serum Insulin Degludec concentration-time curve [ Time Frame: From 0 to 24 hours after single dose ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg 100 U/mL Drug: insulin degludec
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
Experimental: IDeg 200 U/mL Drug: insulin degludec
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.

  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:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
  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: NCT01076634

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

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01076634     History of Changes
Other Study ID Numbers: NN1250-3678, 2009-014555-68, U1111-1112-7714
Study First Received: February 24, 2010
Last Updated: June 12, 2014
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
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014