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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart 30

Drug

insulin glargine

Drug

insulin glulisine

Drug

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Jan 19, 2009
Registry last updated: Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed