Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes

This study has been completed.

First Received: January 28, 2008 Last Updated: November 27, 2008 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00612599

Purpose

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes.

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

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Non-Obese and Obese With Type 2 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Area under the serum glucose concentration profile during 24 hours [ Time Frame: after 4 weeks of treatment ]

Secondary Outcome Measures:

Pharmacodynamics properties
Pharmacokinetic properties
8-point self-monitored blood glucose profiles
Adverse events
Hypoglycaemic episodes

Estimated Enrollment:	72
Study Start Date:	September 2003

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes for at least 12 months
Stable glycaemic control, having been on the existing treatment for at least 1 month
BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese)
HbA1c below 9.0%
Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly

Exclusion Criteria:

A history of drug abuse or alcohol dependence
Blood donation within the last 3 months
Currently being treated with systemic corticosteroids, Mono Amine Oxidase (MAO) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose
Severe, uncontrolled hypertension
Proliferative retinopathy or maculopathy requiring acute treatment
Pregnancy, breast-feeding, intention of becoming pregnant or judged not to be using adequate contraceptive measures (for women of childbearing potential only contraceptive pills and intra uterine devices are considered as adequate contraceptive methods)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612599

Locations

Denmark

Århus C, Denmark, 8000

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Plamen Kozlovski

Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	BIASP-1526
Study First Received:	January 28, 2008
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00612599 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Obesity
Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009