Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMix® 30) in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868568
• Other study ID #: NN5401-1959
• Secondary ID: 2007-006110-42
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2013
• Last updated: October 21, 2015
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2015
• 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 compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results

• Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months

• Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

• A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator

• A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies

• A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing

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 1

Intervention

Drug:
• insulin degludec
Administered subcutaneously (s.c., under the skin).
• insulin degludec/insulin aspart 30
A single dose administered subcutaneously (s.c., under the skin).
• insulin degludec/insulin aspart 40
A single dose administered subcutaneously (s.c., under the skin).
• insulin degludec/insulin aspart 45
A single dose administered subcutaneously (s.c., under the skin).
• insulin degludec/insulin aspart 55
A single dose administered subcutaneously (s.c., under the skin).
• insulin aspart
A single dose administered subcutaneously (s.c., under the skin).
• biphasic insulin aspart 30
A single dose administered subcutaneously (s.c., under the skin).
• placebo
A single dose administered subcutaneously (s.c., under the skin).

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 insulin aspart concentration curve		0-2 hours after dosing	No
Secondary	Area under the glucose infusion rate curve		0-26 hours after dosing	No
Secondary	Area under the serum insulin 454 concentration curve		0-120 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk