Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes

March 15, 2017 updated by: Novo Nordisk A/S

Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Soluble Insulin in Geriatric Subjects With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Köln, Germany, 50825
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glucose infusion rate Time Frame: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))	in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))

Secondary Outcome Measures

Outcome Measure	Time Frame
AUCGIR(0-300 min) the area under the GIR profile Time Frame: in the interval 0-300 minutes post dosing	in the interval 0-300 minutes post dosing
AUCGIR(0 min-end of clamp) the area under the GIR profile Time Frame: 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)	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)
AUCGIR(300min-end of clamp) the area under the GIR profile Time Frame: 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)	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)
GIRmax: the maximal GIR value Time Frame: tmax, GIR: the time to maximal GIR value	tmax, GIR: the time to maximal GIR value
early and late t50%, GIR Time Frame: the time to early and late half-maximal GIR value	the time to early and late half-maximal GIR value
AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile Time Frame: in the interval 0-60 minutes post dosing	in the interval 0-60 minutes post dosing
AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile Time Frame: in the interval 0-300 minutes post dosing	in the interval 0-300 minutes post dosing
AUCINS(0min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile Time Frame: 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)	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 Time Frame: 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)	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)
Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2002

Primary Completion (ACTUAL)

July 19, 2002

Study Completion (ACTUAL)