Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Double-blind, Multiple Period Crossover Trial Comparing Insulin 454 and Insulin Aspart Premixes With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared With Biphasic Insulin Aspart 30 (NovoMix® 30) in Male Subjects With Type 1 and Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865305
• Other study ID #: NN5401-1738
• Secondary ID: 2006-002430-37
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2013
• Last updated: October 22, 2015
• Start date: September 2006
• Est. completion date: February 2007

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 different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.

Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. Each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments.

Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator

• Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results

• ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:

• Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months

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

• ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:

• Diagnosed with type 2 diabetes mellitus for at least 12 months

• Treated with insulin for the last 3 months prior to screening.

• Body Mass Index (BMI) between 22.0 and 35.0 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 trial product, as judged by the Investigator

• 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
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin).
• insulin degludec/insulin aspart 40
Single dose administrated subcutaneously (s.c., under the skin).
• insulin degludec/insulin aspart 50
Single dose administrated subcutaneously (s.c., under the skin).
• insulin degludec
Single dose administrated subcutaneously (s.c., under the skin).
• insulin aspart
Single dose administrated subcutaneously (s.c., under the skin).
• biphasic insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin) as comparator.
• insulin degludec/insulin aspart 40
Single dose administrated subcutaneously (s.c., under the skin).
• insulin degludec/insulin aspart 50
Single dose administrated subcutaneously (s.c., under the skin).
• biphasic insulin aspart 30
Single dose administrated 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 from 0-2 hours (for subjects with type 1 diabetes)		0-2 hours after dosing	No
Primary	Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)		0-24 hours after dosing	No
Secondary	Area under the glucose infusion rate curve		0-24 hours after dosing	No
Secondary	Area under the serum insulin degludec concentration curve		0-96 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk