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

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


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

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 A/S
Investigators
Study Director: Lisbeth V. Jacobsen Novo Nordisk A/S
  More Information

Additional Information:
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 April 23, 2014