A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacodynamic Properties of NN5401 in Young Adults and Geriatric Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174303
• Other study ID #: NN5401-1981
• Secondary ID: U1111-1114-93732
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2010
• Last updated: February 9, 2017
• Start date: August 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 is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months

• Body mass index 18.0-28.0 kg/m^2 (both inclusive)

• HbA1c (glycosylated haemoglobin A1c) maximum 10.0% by central laboratory analysis

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

• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)

• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec/insulin aspart
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
• biphasic insulin aspart 30
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Brunner M, Pieber T, Korsatko S, Kojzar H, Svendsen AL, Haahr H. The Distinct Prandial and Basal Pharmacodynamics of IDegAsp Observed in Younger Adults Are Preserved in Elderly Subjects with Type 1 Diabetes. Drugs Aging. 2015 Jul;32(7):583-90. doi: 10.100 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Glucose Infusion Rate curve (only for NN5401)		from 0 to 24 hours after single-dose administration
Secondary	Area under the glucose infusion rate curve (only for biphasic insulin aspart 30)		from 0 to 24 hours after single-dose administration

External Links

•   Clinical Trials at Novo Nordisk