Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01520831
First received: January 25, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.


Condition Intervention Phase
Diabetes
Healthy
Drug: biphasic insulin aspart 30
Drug: biphasic insulin aspart 50
Drug: biphasic insulin aspart 70
Drug: insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Four-period Cross-over Trial in Healthy Subjects, Investigating the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Soluble Insulin Aspart

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum GIR value [ Designated as safety issue: No ]
  • Time to maximum GIR value [ Designated as safety issue: No ]
  • Area under the GIR profile [ Designated as safety issue: No ]
  • Cmax, maximum insulin aspart concentration [ Designated as safety issue: No ]
  • Area under the insulin aspart concentration curve [ Designated as safety issue: No ]
  • tmax, the time to maximum insulin aspart concentration [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: April 1999
Study Completion Date: May 2000
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp 30 Drug: biphasic insulin aspart 30
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Experimental: BIAsp 50 Drug: biphasic insulin aspart 50
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Experimental: BIAsp 70 Drug: biphasic insulin aspart 70
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
Active Comparator: Insulin aspart Drug: insulin aspart
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index between 18 and 28 kg/m^2 inclusive
  • HbA1c within the normal laboratory range
  • Non smoker for at least three months
  • Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

Exclusion Criteria:

  • Subjects who have received any investigational drug in the 3 months prior to the start of dosing
  • Any disease requiring regular use of non topical prescription medicines
  • Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
  • Any intercurrent illness or endocrine disorders that may affect blood glucose
  • Subject with a history of drug or alcohol dependence
  • Subject with a first degree relative with diabetes mellitus
  • Subject with a history of clinically relevant allergic reactions to medical products
  • Subjects who have donated any blood or plasma in the past 3 month preceding screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT01520831

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01520831     History of Changes
Other Study ID Numbers: BIASP-1086
Study First Received: January 25, 2012
Last Updated: June 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014