A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01030926
First received: December 11, 2009
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.


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 Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults 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 NN1250 concentration-time curve after single dose [ Time Frame: 0-72 hours after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed NN1250 concentration after single dose [ Time Frame: 0-72 hours after dosing ] [ Designated as safety issue: No ]
  • Time to maximum observed NN1250 concentration after single dose [ Time Frame: 0-72 hours after dosing ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1, first period Drug: insulin degludec
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
Active Comparator: A2, second period Drug: insulin glargine
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
Active Comparator: B1, first period Drug: insulin glargine
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
Experimental: B2, second period Drug: insulin degludec
0.4 U/kg body weight injected subcutaneously (under the skin), single dose

  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 6-65 years (both inclusive)
  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 kg/m^2

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
  • Not able or willing to refrain from smoking during the inpatient period
  • Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030926

Locations
Germany
Hannover, Germany, 30173
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tove K. Stryhn, MSc. Pharm Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01030926     History of Changes
Other Study ID Numbers: NN1250-1995, 2008-008306-43, U1111-1112-4715
Study First Received: December 11, 2009
Last Updated: November 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 17, 2014