Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
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ClinicalTrials.gov Identifier: NCT01527552 |
Recruitment Status :
Completed
First Posted : February 7, 2012
Last Update Posted : February 24, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Healthy | Drug: biphasic insulin aspart 50 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects |
Actual Study Start Date : | November 5, 2002 |
Actual Primary Completion Date : | December 18, 2002 |
Actual Study Completion Date : | December 18, 2002 |

Arm | Intervention/treatment |
---|---|
Experimental: Formulation A |
Drug: biphasic insulin aspart 50
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days |
Experimental: Formulation B |
Drug: biphasic insulin aspart 50
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days |
- Area under the insulin aspart curve in the interval from 0-16 hours
- Cmax, maximum insulin aspart concentration
- tmax, the time to maximum insulin aspart concentration
- Area under the insulin aspart curve
- Mean residence time (MRT)
- The area under the glucose infusion rate 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: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
- Body Mass Index (BMI) between 19-29 kg/m^2 (both inclusive)
- Minimum body weight of 65 kg
- Fasting blood glucose between 3.8-6.0 mmol/L
- Glycohemoglobin (HbA1c) below 6.4 %
- Non-smokers
Exclusion Criteria:
- Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
- A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
- History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
- Hepatitis B or C
- Subjects with a first-degree relative with diabetes mellitus
- Known or suspected allergy to trial product or related products
- Smoking during the past three months

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): NCT01527552
South Africa | |
Novo Nordisk Investigational Site | |
Bloemfontein, South Africa, 9324 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01527552 History of Changes |
Other Study ID Numbers: |
BIASP-1488 |
First Posted: | February 7, 2012 Key Record Dates |
Last Update Posted: | February 24, 2017 |
Last Verified: | February 2017 |
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