A Trial Investigating the Total Exposure of NN5401 (Insulin Degludec/Insulin Aspart) in Children, Adolescents and Adult Subjects With Type 1 Diabetes

NCT01138488 | Completed Phase 1

• 3 other identifiers: NN5401-1982U1111-1113-68742009-016779-31
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This trial was conducted in Europe. The aim of this study was to investigate the total exposure of NN5401 (insulin degludec/insulin aspart) in children, adolescents and adult subjects with type 1 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Area under the serum insulin degludec concentration-time curve

  from 0 to infinity after single-dose

• Area under the serum insulin aspart concentration-time curve

  from 0 to 12 hours after single-dose

Secondary Outcomes (2)

• Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed

  from 0 to 57 hours after single-dose

• Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed

  from 0 to 12 hours after single-dose

Study Arms (1)

NN5401

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

Interventions

insulin degludec/insulin aspart DRUG

Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin).

NN5401

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:

• 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
• HNEC TEST: collaborator

Study Sites (1)

Novo Nordisk Investigational Site

Hanover, 30173, Germany

Location

Related Publications (1)

• Biester T, Danne T, Blasig S, Remus K, Aschemeier B, Kordonouri O, Bardtrum L, Haahr H. Pharmacokinetic and prandial pharmacodynamic properties of insulin degludec/insulin aspart in children, adolescents, and adults with type 1 diabetes. Pediatr Diabetes. 2016 Dec;17(8):642-649. doi: 10.1111/pedi.12358. Epub 2016 Jan 18.

  PMID: 26782928 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

insulin degludec, insulin aspart drug combination

Condition Hierarchy (Ancestors)

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

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

DE (1)