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Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01697618
First received: September 28, 2012
Last updated: October 2, 2012
Last verified: September 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart 30
Drug: biphasic human insulin 30
 Phase 2

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, Double-blind, Single Centre, Two-way Cross-over Trial Comparing the Pharmacokinetics, Pharmacodynamics and Safety of the Biphasic Insulin Aspart 30 and Insulin Mixtard 30/70 After Multiple Dosing With a Twice Daily Dose Regimen in Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the serum insulin curve [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall shape of the 24 hour serum insulin profile [ Designated as safety issue: No ]
  • Cmax (maximum plasma concentration) [ Designated as safety issue: No ]
  • tmax (time to reach maximum) [ Designated as safety issue: No ]
  • Area under the curve following each injections derived from 24 hours serum insulin profiles [ Designated as safety issue: No ]
  • Overall shape of the 24 hour serum glucose profile [ Designated as safety issue: No ]
  • Serum glucose excursions (EXC) [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: April 1997
Study Completion Date: November 1998
Primary Completion Date: November 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp 30 Drug: biphasic insulin aspart 30
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Drug: biphasic human insulin 30
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Active Comparator: BHI 30 Drug: biphasic insulin aspart 30
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Drug: biphasic human insulin 30
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months
  • BMI (body mass index) below 39 kg/m^2
  • HbA1c (glycosylated haemoglobin) below 12%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697618

Locations
Netherlands
Alphen a/d Rijn, Netherlands
United Kingdom
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Lisbeth V. Jacobsen 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: NCT01697618     History of Changes
Other Study ID Numbers: ANA/DCD/046
Study First Received: September 28, 2012
Last Updated: October 2, 2012
Health Authority: Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate
United Kingdom: Medicines and Healthcare Products Regulatory

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013