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

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ClinicalTrials.gov Identifier: NCT01697618
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Drug: biphasic human insulin 30 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : April 1997
Primary Completion Date : November 1998
Study Completion Date : November 1998

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Area under the serum insulin curve

Secondary Outcome Measures :
  1. Overall shape of the 24 hour serum insulin profile
  2. Cmax (maximum plasma concentration)
  3. tmax (time to reach maximum)
  4. Area under the curve following each injections derived from 24 hours serum insulin profiles
  5. Overall shape of the 24 hour serum glucose profile
  6. Serum glucose excursions (EXC)


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697618


Locations
Netherlands
Novo Nordisk Investigational Site
Alphen a/d Rijn, Netherlands
United Kingdom
Novo Nordisk Investigational Site
Crawley, United Kingdom, RH11 9RT
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01697618     History of Changes
Other Study ID Numbers: ANA/DCD/046
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs