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

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic Properties of NN5401 in Children, Adolescents and Adults With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138488
• Other study ID #: NN5401-1982
• Secondary ID: U1111-1113-68742
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2010
• Last updated: February 9, 2017
• Start date: June 2010
• Est. completion date: November 2010

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Novo Nordisk A/S	HNEC TEST

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Biester T, Danne T, Bläsig 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin degludec concentration-time curve		from 0 to infinity after single-dose
Primary	Area under the serum insulin aspart concentration-time curve		from 0 to 12 hours after single-dose
Secondary	Maximum observed insulin degludec concentration of NN5401 (insulin degludec/insulin aspart) observed		from 0 to 57 hours after single-dose
Secondary	Maximum observed insulin aspart concentration of NN5401 (insulin degludec/insulin aspart) observed		from 0 to 12 hours after single-dose

External Links

•   Clinical Trials at Novo Nordisk