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

NCT01865305 | Completed Phase 1

• 2 other identifiers: NN5401-17382006-002430-37
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)

  0-2 hours after dosing

• Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)

  0-24 hours after dosing

Secondary Outcomes (2)

• Area under the glucose infusion rate curve

  0-24 hours after dosing

• Area under the serum insulin degludec concentration curve

  0-96 hours after dosing

Study Arms (2)

Trial part 1

EXPERIMENTAL

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

Trial part 2

EXPERIMENTAL

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

Interventions

insulin degludec/insulin aspart 30 DRUG

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

Trial part 1

insulin degludec/insulin aspart 40 DRUG

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

Trial part 1

insulin degludec/insulin aspart 50 DRUG

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

Trial part 1

insulin degludec DRUG

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

Trial part 1

insulin aspart DRUG

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

Trial part 1

biphasic insulin aspart 30 DRUG

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

Trial part 1

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Neuss, 41460, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

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

Interventions

insulin degludec; Insulin Aspart; insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: May 30, 2013
• Study Start: September 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: October 23, 2015

Record last verified: 2015-10

Locations

DE (1)