Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 in Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00825253

Purpose

This trial is conducted in Europe. The aim of this clinical trial is to compare the pharmacodynamics (i.e. the glucose-lowering effect of the study medication over the entire observation phase from the time of administration and the efficacy period) and the pharmacokinetics (i.e. amount of the study insulin that can be determined in the blood) of a treatment with biphasic insulin aspart 30 (BiAsp 30) administered once, twice or thrice daily and biphasic human insulin 30 administered once daily in type 2 diabetic subjects

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Randomised, Open-Labelled, 4-Period Crossover Trial Characterising Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 Administered Once, Twice or Thrice Daily and Biphasic Human Insulin 30 Administered Once Daily in Subjects With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Enrollment:	24
Study Start Date:	March 2007
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
Type 2 diabetes mellitus diagnosed for at least 12 months prior to screening
HbA1c value between 7% and 10.5% (both inclusive) at screening
Any insulin treatment for at least 3 months prior to screening
Body mass index (BMI): 25 - 40 kg/m2

Exclusion Criteria:

Use of any oral antidiabetic agent within the past 6 months
Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
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 (ALT or AST greater than or equal to 2 times the central laboratory's upper reference limit)
Renal insufficiency (serum creatinine greater than or equal to 1.6 mg/dL for males; greater than or equal to
Recurrent hypoglycaemia or hypoglycaemic unawareness
Anaemia (haemoglobin less than 13.0 mg/dL in males and less than 12.0 mg/dL in females) (WHO criteria)
Use of any systemic or topical medications (prescribed or non-prescribed) which may alter glucose metabolism (other than insulin products), including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
History of substance (e.g. drugs, alcohol) abuse or a positive result in the urine drug/alcohol screen or consumption of more than 14 units (women) or 21 units (men) of alcohol per week (One unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits)
Smoking of more than 20 cigarettes per day and inability to refrain from smoking during the in-house period
Known hepatitis or positive serological tests for the hepatitis B surface antigen (HBsAg) or hepatitis C antibodies or HIV antibodies
Uncontrolled treated/untreated hypertension (systolic blood pressure greater than or equal to 160 mmHg and/or diastolic blood pressure greater than or equal to 95 mmHg)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825253

Locations

Germany

Neuss, Germany, 41460

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Anne Raben, MSc, PhD

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-1831, EudraCT No: 2006-005958-75
Study First Received:	January 14, 2009
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00825253 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

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