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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• 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): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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: NN5401 - low dose	Drug: insulin degludec/insulin aspart; 0.4 U/kg body weight injected subcutaneously (under the skin) once; Drug: insulin degludec/insulin aspart; 0.6 U/kg body weight injected subcutaneously (under the skin) once; Drug: insulin degludec/insulin aspart; 0.8 U/kg body weight injected subcutaneously (under the skin) once
Experimental: NN5401 - medium dose	Drug: insulin degludec/insulin aspart; 0.4 U/kg body weight injected subcutaneously (under the skin) once; Drug: insulin degludec/insulin aspart; 0.6 U/kg body weight injected subcutaneously (under the skin) once; Drug: insulin degludec/insulin aspart; 0.8 U/kg body weight injected subcutaneously (under the skin) once
Experimental: NN5401 - high dose	Drug: insulin degludec/insulin aspart; 0.4 U/kg body weight injected subcutaneously (under the skin) once; Drug: insulin degludec/insulin aspart; 0.6 U/kg body weight injected subcutaneously (under the skin) once; Drug: insulin degludec/insulin aspart; 0.8 U/kg body weight injected subcutaneously (under the skin) once
Active Comparator: biphasic insulin aspart 30 - low dose	Drug: biphasic insulin aspart 30; 0.4 U/kg body weight injected subcutaneously (under the skin) once; Drug: biphasic insulin aspart 30; 0.6 U/kg body weight injected subcutaneously (under the skin) once; Drug: biphasic insulin aspart 30; 0.8 U/kg body weight injected subcutaneously (under the skin) once
Active Comparator: biphasic insulin aspart 30 - medium dose	Drug: biphasic insulin aspart 30; 0.4 U/kg body weight injected subcutaneously (under the skin) once; Drug: biphasic insulin aspart 30; 0.6 U/kg body weight injected subcutaneously (under the skin) once; Drug: biphasic insulin aspart 30; 0.8 U/kg body weight injected subcutaneously (under the skin) once
Active Comparator: biphasic insulin aspart 30 - high dose	Drug: biphasic insulin aspart 30; 0.4 U/kg body weight injected subcutaneously (under the skin) once; Drug: biphasic insulin aspart 30; 0.6 U/kg body weight injected subcutaneously (under the skin) once; Drug: biphasic insulin aspart 30; 0.8 U/kg body weight injected subcutaneously (under the skin) once

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the insulin aspart concentration-time curve	From 0 to 12 hours after single-dose administration
Area under the insulin aspart concentration-time curve (only for BIAsp 30)	From 0 to 24 hours after single-dose administration

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: May 27, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (Estimate): May 31, 2010

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; 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: NN5401-1978; U1111-1113-7056 (Other Identifier: WHO); 2009-015646-30 (EudraCT Number)