Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: insulin degludec/insulin aspart; Drug: insulin degludec/insulin aspart; Drug: insulin degludec/insulin aspart; Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 30

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDegAsp low	Drug: insulin degludec/insulin aspart; Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin); Drug: insulin degludec/insulin aspart; Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin); Drug: insulin degludec/insulin aspart; Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Experimental: IDegAsp middle	Drug: insulin degludec/insulin aspart; Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin); Drug: insulin degludec/insulin aspart; Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin); Drug: insulin degludec/insulin aspart; Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Experimental: IDegAsp high	Drug: insulin degludec/insulin aspart; Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin); Drug: insulin degludec/insulin aspart; Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin); Drug: insulin degludec/insulin aspart; Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Experimental: BIAsp 30 low	Drug: biphasic insulin aspart 30; Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin); Drug: biphasic insulin aspart 30; Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin); Drug: biphasic insulin aspart 30; Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Experimental: BIAsp 30 middle	Drug: biphasic insulin aspart 30; Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin); Drug: biphasic insulin aspart 30; Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin); Drug: biphasic insulin aspart 30; Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Experimental: BIAsp 30 high	Drug: biphasic insulin aspart 30; Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin); Drug: biphasic insulin aspart 30; Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin); Drug: biphasic insulin aspart 30; Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area (AUC) under the glucose infusion rate curve	From 0 to 24 hours after single-dose administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Area (AUC) under the insulin aspart concentration time curve	From 0 to 24 hours after single-dose administration

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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. Epub 2015 May 1.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: October 8, 2009
• First Submitted That Met QC Criteria: October 8, 2009
• First Posted (Estimate): October 9, 2009

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
• Other Study ID Numbers: NN5401-3539; 2008-008472-14 (EudraCT Number); U1111-1111-9032 (Other Identifier: WHO)