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Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00824668
First Posted: January 19, 2009
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to compare the 24-hour pharmacodynamics/ pharmacokinetics of biphasic insulin aspart 30 (BiAsp 30) thrice daily treatment with that of a basal-bolus treatment with insulin glargine and insulin glulisine in type 2 diabetic subjects.

Pharmacodynamics is the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period while the pharmacokinetics is the amount of the study insulin that can be determined in the blood.


Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Drug: insulin glargine Drug: insulin glulisine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Open-labelled, 2-period Crossover Trial Investigating Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 Thrice Daily and Basal-bolus Therapy With Insulin Glargine & Insulin Glulisine in Subjects With Type 2 Diabetes

Resource links provided by NLM:


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

Enrollment: 24
Study Start Date: August 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus for 12 months or longer
  • Body Mass Index (BMI): 25.0-40.0 kg/m2, both inclusive
  • HbA1c between 7.0 and 10.5% at screening
  • Insulin treatment for at least 3 months prior to screening with a total daily dose of 0.6 and 0.9 U/kg body weight

Exclusion Criteria:

  • Use of any oral antidiabetic agent within the past 2 months
  • Cardiac disease: NYHA class III or IV chronic heart failure (CHF), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening
  • Hepatic insufficiency (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or greater than 2 times the central laboratory's upper reference limit)
  • Renal insufficiency (serum creatinine equal to or greater than 1.6 mg/dL for males; equal to or greater than 1.4 mg/dL for females)
  • Recurrent hypoglycaemia
  • Anaemia (haemoglobin less than 13.0 mg/dL in males and less than 12.0 mg/dL in females; WHO-criteria)
  • Use of concomitant medications (prescribed or non-prescribed and other than insulin) which may alter glucose metabolism including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
  Contacts and Locations
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): NCT00824668


Locations
Germany
Novo Nordisk Investigational Site
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:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00824668     History of Changes
Other Study ID Numbers: BIASP-1832
2006-006578-92 ( EudraCT Number )
First Submitted: January 14, 2009
First Posted: January 19, 2009
Last Update Posted: January 6, 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 glulisine
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs