Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)

NCT01530048 | Completed Phase 1

• 2 other identifiers: PDS290-17502005-005538-11
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the curve (AUC) in the interval of 0-6 hours

• Cmax, maximum concentration

Secondary Outcomes (9)

• AUC in the interval of 0-infinity hours

• tmax, time to reach Cmax

• Terminal rate constant

• Vz/f, volume of distribution during terminal phase

• t½, terminal half-life

Study Arms (2)

U200

EXPERIMENTAL

Drug: insulin aspart

U100

ACTIVE COMPARATOR

Drug: insulin aspart

Interventions

insulin aspart DRUG

A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between

U100; U200

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
• Body mass index between 18 and 27 kg/m\^2 (both inclusive)
• Non-smoker
• Fasting blood glucose maximum 6 mmol/L
• HbA1c below 6.4%

You may not qualify if:

• Pregnant or breast-feeding women
• Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
• Clinically significant abnormal laboratory values (as judged by the Investigator)
• Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
• Intake of alcohol within the last 24 hours prior to screening and drug administration visits
• Blood donation or blood loss of more than 500 mL within the 3 last months before screening
• Strenuous exercise within 48 hours before screening as well as drug administration and followup
• Smoking during the past month before drug administration

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Hvidovre, 2650, Denmark

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: February 7, 2012
• First Posted: February 9, 2012
• Study Start: March 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

DK (1)