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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: biphasic insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT00612599

BIASP-1526

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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)