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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 30; Drug: insulin degludec; Drug: insulin degludec/insulin aspart 50; Drug: insulin degludec/insulin aspart 30; Drug: insulin aspart; Drug: insulin degludec/insulin aspart 40

Study type: Interventional

Funder types: Industry

Identifiers

NCT01865305

NN5401-1738

2006-002430-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: Male

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

59 participants in 2 patient groups

Trial part 1

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart 40

Drug: insulin degludec/insulin aspart 50

Drug: insulin degludec

Drug: biphasic insulin aspart 30

Drug: insulin degludec/insulin aspart 30

Drug: insulin degludec/insulin aspart 50

Drug: biphasic insulin aspart 30

Drug: insulin degludec/insulin aspart 40

Drug: insulin aspart

Trial part 2

Experimental group

Treatment:

Drug: insulin degludec/insulin aspart 40

Drug: insulin degludec/insulin aspart 50

Drug: biphasic insulin aspart 30

Drug: insulin degludec/insulin aspart 50

Drug: biphasic insulin aspart 30

Drug: insulin degludec/insulin aspart 40