Status:
COMPLETED
Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-70 years
Phase:
PHASE3
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 tim...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00612599
Start Date
September 1 2003
End Date
June 1 2004
Last Update
January 6 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Århus C, Denmark, 8000