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

NCT01030926 | Completed Phase 1

• 3 other identifiers: NN1250-19952008-008306-43U1111-1112-4715
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Area under the NN1250 concentration-time curve after single dose

  0-72 hours after dosing

Secondary Outcomes (2)

• Maximum observed NN1250 concentration after single dose

  0-72 hours after dosing

• Time to maximum observed NN1250 concentration after single dose

  0-72 hours after dosing

Study Arms (4)

A1, first period

EXPERIMENTAL

Drug: insulin degludec

A2, second period

ACTIVE COMPARATOR

Drug: insulin glargine

B1, first period

ACTIVE COMPARATOR

Drug: insulin glargine

B2, second period

EXPERIMENTAL

Drug: insulin degludec

Interventions

insulin degludec DRUG

0.4 U/kg body weight injected subcutaneously (under the skin), single dose

A1, first period; B2, second period

insulin glargine DRUG

0.4 U/kg body weight injected subcutaneously (under the skin), single dose

A2, second period; B1, first period

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Hanover, 30173, Germany

Location

Related Publications (1)

• Biester T, Blaesig S, Remus K, Aschemeier B, Kordonouri O, Granhall C, Sondergaard F, Kristensen NR, Haahr H, Danne T. Insulin degludec's ultra-long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2014 Feb;15(1):27-33. doi: 10.1111/pedi.12116.

  PMID: 24467565 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

insulin degludec; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

DE (1)