Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers

Profil Institut für Stoffwechselforschung GmbH12 enrolled

Overview

The purpose of this study was to compare the pharmacodynamics (course of the blood glucose-lowering effect and duration of effect) and pharmacokinetics (course of the concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg of insulin glulisine and insulin aspart in a direct head-to-head comparison during two euglycemic glucose clamps in healthy subjects.

In a previous glucose clamp study with a head-to-head comparison of insulin glulisine and insulin lispro it was shown that the onset of metabolic action was significantly shorter with insulin glulisine than with insulin lispro (while the total metabolic effect was not different). These results were in line with a faster early insulin exposure of insulin glulisine compared to insulin lispro. The primary aim of this study was to investigate whether or not these favorable characteristics of insulin glulisine were also evident in the comparison against insulin aspart. This was the first clinical study realizing a head-to-head comparison between these two insulin analogs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Diabetes

Interventions

insulin glulisine, insulin aspartDRUG

single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during second euglycemic glucose clamp

insulin aspart, insulin glulisineDRUG

single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during second euglycemic glucose clamp

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Overtly healthy males or females (Women: contraception, Pearl Index \<1%) * Between the ages of 18 and 65 years * Body Mass Index of \<= 27 kg/m² * Safety lab within reference range * Normal blood pressure and heart rate * Sufficient venous access * Written informed consent approved by the Ethical Review Board * HbA1c and fasting plasma glucose in the normal range Exclusion Criteria: * Investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees * Within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval * Known allergies to insulin or related compounds * Regular treatment with any drug, both over-the-counter or prescribed * an abnormality in the 12-lead ECG increasing the risk for participation * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * Significant active neuropsychiatric disease * Regular use of drugs of abuse and or positive findings on urinary drug screening * Evidence of HIV and/or positive antibodies 1 or 2 and or HIV1 antigen * Evidence of hepatitis B and/or positive hepatitis C antibody * Evidence of hepatitis B and/or positive hepatitis B surface antigen * Women with a positive pregnancy test or breastfeeding women * Blood donation more than 500 mL within the last 3 months

Locations (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Outcomes

Primary Outcomes

fractional and total glucose infusion rates

Time frame: 0-1 hours, 0-2 hours, and time to 10% of GIRmax

Secondary Outcomes

fractional and total insulin areas under the curve (AUC)

Time frame: 0-1 hours, 0-2 hours, 0-10 hours

Data from ClinicalTrials.gov

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