Clinical trial NCT00676819: Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes
Official title: Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Soluble Insulin in Geriatric Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 19
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Glucose infusion rate
timeFrame: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))
Secondary outcomes:
measure: AUCGIR(0-300 min) the area under the GIR profile
timeFrame: in the interval 0-300 minutes post dosing
measure: AUCGIR(0 min-end of clamp) the area under the GIR profile
timeFrame: 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)
measure: AUCGIR(300min-end of clamp) the area under the GIR profile
timeFrame: 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)
measure: GIRmax: the maximal GIR value
timeFrame: tmax, GIR: the time to maximal GIR value
measure: early and late t50%, GIR
timeFrame: the time to early and late half-maximal GIR value
measure: AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile
timeFrame: in the interval 0-60 minutes post dosing
measure: AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile
timeFrame: in the interval 0-300 minutes post dosing
measure: AUCINS(0min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile
timeFrame: 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)
measure: AUCINS(300min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile
timeFrame: 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)
measure: Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Krones R, Schutte C, Heise T. The rapid-acting properties of insulin aspart are preserved in elderly people with type 2 diabetes. Diabetes Obes Metab. 2009 Jan;11(1):41-4. doi: 10.1111/j.1463-1326.2008.00988.x.