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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT01530048
• Date of registration: 07/02/2012
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)
• Scientific 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
• Date of first enrolment: March 2006
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01530048
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Denmark

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes

Healthy

Intervention(s)

Drug: insulin aspart

Primary Outcome(s)

Cmax, maximum concentration [Time Frame: No]

Area under the curve (AUC) in the interval of 0-6 hours [Time Frame: No]

Secondary Outcome(s)

Vz/f, volume of distribution during terminal phase [Time Frame: No]

Terminal rate constant [Time Frame: No]

Adverse events [Time Frame: No]

t½, terminal half-life [Time Frame: No]

AUC in the interval of 0-infinity hours [Time Frame: No]

AUCGIR, area under the glucose infusion rate value curve [Time Frame: No]

GIRmax, maximum glucose infusion rate value [Time Frame: No]

tGIRmax, time to maximum glucose infusion rate value [Time Frame: No]

tmax, time to reach Cmax [Time Frame: No]

Secondary ID(s)

2005-005538-11

PDS290-1750

Source(s) of Monetary Support

Please refer to primary and secondary sponsors