Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01487811

First Posted: December 7, 2011

Last Update Posted: January 6, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novo Nordisk A/S

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 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

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human Insulin aspart

U.S. FDA Resources

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
Maximum drug concentration of the two formulations (Cmax)

Secondary Outcome Measures:

Area under the concentration curve for insulin aspart from time 0 hours to 16 hours
Mean residence time (MRT)
Frequency of adverse events


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

Locations


United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Publications:

Hanefeld M, Fischer S, Julius U, Schulze J, Schwanebeck U, Schmechel H, Ziegelasch HJ, Lindner J. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up. Diabetologia. 1996 Dec;39(12):1577-83.

Standl E, Balletshofer B, Dahl B, Weichenhain B, Stiegler H, Hörmann A, Holle R. Predictors of 10-year macrovascular and overall mortality in patients with NIDDM: the Munich General Practitioner Project. Diabetologia. 1996 Dec;39(12):1540-5.

The absence of a glycemic threshold for the development of long-term complications: the perspective of the Diabetes Control and Complications Trial. Diabetes. 1996 Oct;45(10):1289-98.


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01487811 History of Changes
Other Study ID Numbers:	BIASP-1669
First Submitted:	December 5, 2011
First Posted:	December 7, 2011
Last Update Posted:	January 6, 2017
Last Verified:	January 2017

Additional relevant MeSH terms:


Insulin, Globin Zinc Insulin degludec, insulin aspart drug combination Insulin aspart, insulin aspart protamine drug combination 30:70 Insulin Insulin Aspart	Insulin, Long-Acting Biphasic Insulins Insulin, Isophane Hypoglycemic Agents Physiological Effects of Drugs

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