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

October 22, 2015 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Neuss, Germany, 41460

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trial part 1	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: biphasic insulin aspart 30 Single dose administrated subcutaneously (s.c., under the skin).
Experimental: Trial part 2	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) as comparator. Drug: biphasic insulin aspart 30 Single dose administrated subcutaneously (s.c., under the skin).