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

• ClinicalTrials.gov Identifier: NCT01487811
• Recruitment Status: Completed
• First Posted: December 7, 2011
• Last Update Posted: January 6, 2017
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes; Healthy	Drug: biphasic insulin aspart 30	Phase 1

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity
2. Maximum drug concentration of the two formulations (Cmax)

Secondary Outcome Measures :

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

Eligibility Criteria

• 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

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 

Publications of Results:

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 Posted: December 7, 2011
• Last Update Posted: January 6, 2017
• Last Verified: January 2017

Additional relevant MeSH terms:

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