A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134224
• Other study ID #: NN5401-1978
• Secondary ID: U1111-1113-70562
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2010
• Last updated: November 26, 2013
• Start date: May 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2013
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months

• Body mass index below or equal to 35.0 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/insulin aspart
0.4 U/kg body weight injected subcutaneously (under the skin) once
• insulin degludec/insulin aspart
0.6 U/kg body weight injected subcutaneously (under the skin) once
• insulin degludec/insulin aspart
0.8 U/kg body weight injected subcutaneously (under the skin) once
• biphasic insulin aspart 30
0.4 U/kg body weight injected subcutaneously (under the skin) once
• biphasic insulin aspart 30
0.6 U/kg body weight injected subcutaneously (under the skin) once
• biphasic insulin aspart 30
0.8 U/kg body weight injected subcutaneously (under the skin) once

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve (only for IDegAsp)		From 0 to 24 hours after single-dose	No
Secondary	Area under the insulin aspart concentration-time curve		From 0 to 12 hours after single-dose administration	No
Secondary	Area under the insulin aspart concentration-time curve (only for BIAsp 30)		From 0 to 24 hours after single-dose administration	No

External Links

•   Clinical Trials at Novo Nordisk