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

• ClinicalTrials.gov Identifier: NCT01530048
• Recruitment Status: Completed
• First Posted: February 9, 2012
• Last Update Posted: October 17, 2016
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes; Healthy	Drug: insulin aspart	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial, Assessing the Bioequivalence Between Insulin Aspart 100 U/mL and Insulin Aspart 200 U/mL in Healthy Individuals
• Study Start Date: March 2006
• Actual Primary Completion Date: May 2006
• Actual Study Completion Date: May 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: U200	Drug: insulin aspart; 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
Active Comparator: U100	Drug: insulin aspart; 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

Outcome Measures

Primary Outcome Measures :

1. Area under the curve (AUC) in the interval of 0-6 hours
2. Cmax, maximum concentration

Secondary Outcome Measures :

1. AUC in the interval of 0-infinity hours
2. tmax, time to reach Cmax
3. Terminal rate constant
4. Vz/f, volume of distribution during terminal phase
5. t½, terminal half-life
6. AUCGIR, area under the glucose infusion rate value curve
7. GIRmax, maximum glucose infusion rate value
8. tGIRmax, time to maximum glucose infusion rate value
9. Adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Denmark

Novo Nordisk Investigational Site

Hvidovre, Denmark, 2650

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk 

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01530048
• Other Study ID Numbers: PDS290-1750; 2005-005538-11 ( EudraCT Number )
• First Posted: February 9, 2012
• Last Update Posted: October 17, 2016
• Last Verified: October 2016

Additional relevant MeSH terms:

Insulin Aspart; Hypoglycemic Agents; Physiological Effects of Drugs