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Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01536028
First received: February 15, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics after a single dose of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in subjects with type 1 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 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 Double-blind, Randomised, Four-Period Crossover Trial Comparing the Pharmacodynamics and Pharmacokinetics After Single Dose of Biphasic Insulin Aspart 30, Biphasic Insulin Aspart 50, Biphasic Insulin Aspart 70 and Insulin Aspart in Subjects With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing [ 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-curves [ Designated as safety issue: No ]
  • Maximum drug concentration for insulin aspart (IAsp) [ Designated as safety issue: No ]
  • Time to maximum IAsp concentration [ Designated as safety issue: No ]
  • Area under the curve of the IAsp profiles [ Designated as safety issue: No ]
  • Minimum drug concentration in NEFA (Nonesterified fatty acids) [ Designated as safety issue: No ]
  • Time to minimum plasma concentration, NEFA [ Designated as safety issue: No ]
  • Area under the curve of the NEFA profiles [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: April 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BIAsp 30 Drug: biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Experimental: BIAsp 50 Drug: biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Experimental: BIAsp 70 Drug: biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Active Comparator: IAsp Drug: biphasic insulin aspart 30
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: biphasic insulin aspart 50
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: biphasic insulin aspart 70
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
Drug: insulin aspart
A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes for at least 12 months
  • Serum C-peptide maximum 0.4 ng/mL
  • Current basal bolus treatment with soluble human insulin, insulin lispro, insulin glulisine, NPH insulin, insulin detemir or insulin glargine
  • BMI (Body Mass Index) maximum 32 kg/m^2
  • HbA1c (glycosylated haemoglobin) maximum 9% based on analysis from central laboratory
  • Non-smoker

Exclusion Criteria:

  • The receipt of any investigational drug within the last 30 days prior to this trial
  • Total daily insulin dose at least 1.8 U/kg/day
  • Current treatment with IAsp (insulin aspart) products
  • A history of drug or alcohol abuse within the last 5 years
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac problems
  • Severe, uncontrolled hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536028

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jakob Nis Nielsen Novo Nordisk
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01536028     History of Changes
Other Study ID Numbers: BIASP-1746, 2005-004965-40
Study First Received: February 15, 2012
Last Updated: February 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013