Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01487811
First received: December 5, 2011
Last updated: August 30, 2012
Last verified: August 2012
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Purpose
This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Healthy |
Drug: biphasic insulin aspart 30 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity [ Designated as safety issue: No ]
- Maximum drug concentration of the two formulations (Cmax) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Area under the concentration curve for insulin aspart from time 0 hours to 16 hours [ Designated as safety issue: No ]
- Mean residence time (MRT) [ Designated as safety issue: No ]
- Frequency of adverse events [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | May 2005 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487811
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487811
Locations
| United States, Texas | |
| Novo Nordisk Clinical Trial Call Center | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | William Lyness | Novo Nordisk A/S |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01487811 History of Changes |
| Other Study ID Numbers: | BIASP-1669 |
| Study First Received: | December 5, 2011 |
| Last Updated: | August 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Biphasic Insulins Insulin Aspart Insulin aspart, insulin aspart protamine drug combination 30:70 Insulin, Isophane |
Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015