Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes

NCT01868568 | Completed Phase 1

• 2 other identifiers: NN5401-19592007-006110-42
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Area under the insulin aspart concentration curve

  0-2 hours after dosing

Secondary Outcomes (2)

• Area under the glucose infusion rate curve

  0-26 hours after dosing

• Area under the serum insulin 454 concentration curve

  0-120 hours after dosing

Study Arms (9)

IDegAsp 30 + placebo

EXPERIMENTAL

Drug: insulin degludec/insulin aspart 30; Drug: placebo

Insulin aspart + insulin degludec - low concentration 1

EXPERIMENTAL

Drug: insulin degludec; Drug: insulin aspart

IDegAsp 40 + placebo

EXPERIMENTAL

Drug: insulin degludec/insulin aspart 40; Drug: placebo

Insulin aspart + insulin degludec - high concentration 1

EXPERIMENTAL

Drug: insulin degludec; Drug: insulin aspart

IDegAsp 45 + placebo

EXPERIMENTAL

Drug: insulin degludec/insulin aspart 45; Drug: placebo

Insulin aspart + insulin degludec

EXPERIMENTAL

Drug: insulin degludec; Drug: insulin aspart

IDegAsp 55 + placebo

EXPERIMENTAL

Drug: insulin degludec/insulin aspart 55; Drug: placebo

Insulin aspart + insulin degludec - high concentration

EXPERIMENTAL

Drug: insulin degludec; Drug: insulin aspart

BIAsp 30 + placebo

ACTIVE COMPARATOR

Drug: biphasic insulin aspart 30; Drug: placebo

Interventions

insulin degludec DRUG

Administered subcutaneously (s.c., under the skin).

Insulin aspart + insulin degludec; Insulin aspart + insulin degludec - high concentration; Insulin aspart + insulin degludec - high concentration 1; Insulin aspart + insulin degludec - low concentration 1

insulin degludec/insulin aspart 30 DRUG

A single dose administered subcutaneously (s.c., under the skin).

IDegAsp 30 + placebo

insulin degludec/insulin aspart 40 DRUG

A single dose administered subcutaneously (s.c., under the skin).

IDegAsp 40 + placebo

insulin degludec/insulin aspart 45 DRUG

A single dose administered subcutaneously (s.c., under the skin).

IDegAsp 45 + placebo

insulin degludec/insulin aspart 55 DRUG

A single dose administered subcutaneously (s.c., under the skin).

IDegAsp 55 + placebo

insulin aspart DRUG

A single dose administered subcutaneously (s.c., under the skin).

Insulin aspart + insulin degludec; Insulin aspart + insulin degludec - high concentration; Insulin aspart + insulin degludec - high concentration 1; Insulin aspart + insulin degludec - low concentration 1

biphasic insulin aspart 30 DRUG

A single dose administered subcutaneously (s.c., under the skin).

BIAsp 30 + placebo

placebo DRUG

A single dose administered subcutaneously (s.c., under the skin).

BIAsp 30 + placebo; IDegAsp 30 + placebo; IDegAsp 40 + placebo; IDegAsp 45 + placebo; IDegAsp 55 + placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
• Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months
• Body Mass Index (BMI) between 18.0 and 27.0 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 trialproduct, as judged by the Investigator
• A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies
• 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

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 30, 2013
• First Posted: June 4, 2013
• Study Start: April 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

DE (1)