Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993096
• Other study ID #: NN5401-3539
• Secondary ID: 2008-008472-14U1
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2009
• Last updated: February 9, 2017
• Start date: September 2009
• Est. completion date: December 2009

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 clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.

The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

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

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)

• Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic

• 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
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
• insulin degludec/insulin aspart
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
• insulin degludec/insulin aspart
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
• biphasic insulin aspart 30
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
• biphasic insulin aspart 30
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
• biphasic insulin aspart 30
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Heise T, Nosek L, Klein O, Coester H, Svendsen AL, Haahr H. Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):659-64. doi: 10.1111/dom.12463. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area (AUC) under the glucose infusion rate curve		From 0 to 24 hours after single-dose administration
Secondary	Area (AUC) under the insulin aspart concentration time curve		From 0 to 24 hours after single-dose administration

External Links

•   Clinical Trials at Novo Nordisk