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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030926
• Other study ID #: NN1250-1995
• Secondary ID: 2008-008306-43U1
• Status: Completed
• Phase: Phase 1
• First received: December 11, 2009
• Last updated: January 19, 2017
• Start date: December 2009
• Est. completion date: May 2010

Study information

• Verified date: January 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
0.4 U/kg body weight injected subcutaneously (under the skin), single dose
• insulin glargine
0.4 U/kg body weight injected subcutaneously (under the skin), single dose

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Biester T, Blaesig S, Remus K, Aschemeier B, Kordonouri O, Granhall C, Søndergaard 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 diabete — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the NN1250 concentration-time curve after single dose		0-72 hours after dosing
Secondary	Maximum observed NN1250 concentration after single dose		0-72 hours after dosing
Secondary	Time to maximum observed NN1250 concentration after single dose		0-72 hours after dosing

External Links

•   Clinical Trials at Novo Nordisk