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

NCT ID: NCT01865305

Last Updated: 2015-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-02-28

Brief 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.

Conditions

Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Trial part 1

Group Type: EXPERIMENTAL

insulin degludec/insulin aspart 30

Intervention Type: DRUG

Single dose administrated subcutaneously (s.c., under the skin).

insulin degludec/insulin aspart 40

Intervention Type: DRUG

Single dose administrated subcutaneously (s.c., under the skin).

insulin degludec/insulin aspart 50

Intervention Type: DRUG

Single dose administrated subcutaneously (s.c., under the skin).

insulin degludec

Intervention Type: DRUG

Single dose administrated subcutaneously (s.c., under the skin).

insulin aspart

Intervention Type: DRUG

Single dose administrated subcutaneously (s.c., under the skin).

biphasic insulin aspart 30

Intervention Type: DRUG

Single dose administrated subcutaneously (s.c., under the skin) as comparator.

Trial part 2

Group Type: EXPERIMENTAL

insulin degludec/insulin aspart 40

Intervention Type: DRUG

Single dose administrated subcutaneously (s.c., under the skin).

insulin degludec/insulin aspart 50

Intervention Type: DRUG

Single dose administrated subcutaneously (s.c., under the skin).

biphasic insulin aspart 30

Intervention Type: DRUG

Single dose administrated subcutaneously (s.c., under the skin).

Interventions

insulin degludec/insulin aspart 30

Single dose administrated subcutaneously (s.c., under the skin).

Intervention Type: DRUG

insulin degludec/insulin aspart 40

Single dose administrated subcutaneously (s.c., under the skin).

Intervention Type: DRUG

insulin degludec/insulin aspart 50

Single dose administrated subcutaneously (s.c., under the skin).

Intervention Type: DRUG

insulin degludec

Single dose administrated subcutaneously (s.c., under the skin).

Intervention Type: DRUG

insulin aspart

Single dose administrated subcutaneously (s.c., under the skin).

Intervention Type: DRUG

biphasic insulin aspart 30

Single dose administrated subcutaneously (s.c., under the skin) as comparator.

Intervention Type: DRUG

insulin degludec/insulin aspart 40

Single dose administrated subcutaneously (s.c., under the skin).

Intervention Type: DRUG

insulin degludec/insulin aspart 50

Single dose administrated subcutaneously (s.c., under the skin).

Intervention Type: DRUG

biphasic insulin aspart 30

Single dose administrated subcutaneously (s.c., under the skin).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Neuss, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2006-002430-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN5401-1738

Identifier Type: -

Identifier Source: org_study_id