Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00612599
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Area under the serum glucose concentration profile during 24 hours after 4 weeks of treatment
- Secondary Outcome Measures
Name Time Method Pharmacokinetic properties 8-point self-monitored blood glucose profiles Pharmacodynamics properties Hypoglycaemic episodes Adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Århus C, Denmark