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

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

Interventions

DRUG

insulin degludec/insulin aspart 30

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

DRUG

insulin degludec/insulin aspart 40

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

DRUG

insulin degludec/insulin aspart 50

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

DRUG

insulin degludec

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

DRUG

insulin aspart

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

DRUG

biphasic insulin aspart 30

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

DRUG

insulin degludec/insulin aspart 40

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

DRUG

insulin degludec/insulin aspart 50

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

DRUG

biphasic insulin aspart 30

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

Sponsors & Collaborators

• Novo Nordisk A/S

  lead INDUSTRY

Principal Investigators

• Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-09-30

Primary Completion

2007-02-28

Completion

2007-02-28

Countries

• Germany

Study Locations