Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)
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ClinicalTrials.gov Identifier: NCT01530048 |
Recruitment Status :
Completed
First Posted : February 9, 2012
Last Update Posted : October 17, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Healthy | Drug: insulin aspart | Phase 1 |
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 |

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 |
- Area under the curve (AUC) in the interval of 0-6 hours
- Cmax, maximum concentration
- 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
- AUCGIR, area under the glucose infusion rate value curve
- GIRmax, maximum glucose infusion rate value
- tGIRmax, time to maximum glucose infusion rate value
- Adverse events

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530048
Denmark | |
Novo Nordisk Investigational Site | |
Hvidovre, Denmark, 2650 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
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 Key Record Dates |
Last Update Posted: | October 17, 2016 |
Last Verified: | October 2016 |
Insulin Aspart Hypoglycemic Agents Physiological Effects of Drugs |