Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes
Phase 4
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Registration Number
- NCT00676819
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- Type 2 diabetes
- Duration of diabetes for at least 12 months
- Current treatment with human insulin or insulin analogues for at least 6 months
- BMI equal to or below 35 kg/m2
- HbA1c equal to or greater than 10.0 %
- No clinically significant cardiovascular event as judged by the Investigator within the last 6 months prior to the study
Exclusion Criteria
- History of any illness that, in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the trial products to the subject
- Current treatment with systemic corticosteroids
- Any positive reaction of drug of abuse or alcohol screen
- Cardiac problems defined as: decompensated heart failure and/or angina pectoris
- Uncontrolled treated/untreated hypertension as judged by the Investigator or blood pressure > 180 mm Hg systolic and/or > 110 mm Hg diastolic
- Known or suspected allergy to trial product or related products
- Blood donation of more than 500 ml within the last 12 weeks
- The receipt of any investigational drug within 4 weeks prior to this trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Glucose infusion rate in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))
- Secondary Outcome Measures
Name Time Method GIRmax: the maximal GIR value tmax, GIR: the time to maximal GIR value AUCGIR(0-300 min) the area under the GIR profile in the interval 0-300 minutes post dosing AUCGIR(300min-end of clamp) the area under the GIR profile in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values) early and late t50%, GIR the time to early and late half-maximal GIR value AUCINS(0min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values) Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile in the interval 0-60 minutes post dosing AUCGIR(0 min-end of clamp) the area under the GIR profile in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values) AUCINS(300min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values) AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile in the interval 0-300 minutes post dosing
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Köln, Germany