Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01487811 |
Recruitment Status :
Completed
First Posted : December 7, 2011
Last Update Posted : January 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Healthy | Drug: biphasic insulin aspart 30 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol): A Randomized, Double-Blind, Two-Period Crossover Study in Healthy Volunteers |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | November 2005 |
Actual Study Completion Date : | November 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: Formulation 1 |
Drug: biphasic insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin) |
Active Comparator: Formulation 2 |
Drug: biphasic insulin aspart 30
Single dose administrated subcutaneously (s.c., under the skin) |
- Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity
- Maximum drug concentration of the two formulations (Cmax)
- Area under the concentration curve for insulin aspart from time 0 hours to 16 hours
- Mean residence time (MRT)
- Frequency of adverse events

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI (body mass index) between 18 and 28 kg/m^2, both inclusive
- Subject is a nonsmoker for at least 3 months
- Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
- Fasting plasma glucose between 80 and 110 mg/dl
Exclusion Criteria:
- •Any clinically significant disease history of systemic or organ disease
- •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
- •In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative

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): NCT01487811
United States, Texas | |
Novo Nordisk Investigational Site | |
San Antonio, Texas, United States, 78229 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01487811 |
Other Study ID Numbers: |
BIASP-1669 |
First Posted: | December 7, 2011 Key Record Dates |
Last Update Posted: | January 6, 2017 |
Last Verified: | January 2017 |
Insulin Aspart Biphasic Insulins Insulin aspart, insulin aspart protamine drug combination 30:70 Hypoglycemic Agents Physiological Effects of Drugs |