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

Novo Nordisk A/S19 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin aspartDRUG

human insulinDRUG

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Cologne, Germany

Outcomes

Primary Outcomes

Glucose infusion rate

Time frame: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))

Secondary Outcomes

AUCGIR(0-300 min) the area under the GIR profile

Time frame: 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)

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)

GIRmax: the maximal GIR value

Time frame: 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

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

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

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)

Data from ClinicalTrials.gov

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