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

Profil Institut für Stoffwechselforschung

Status and phase: Completed; Phase 1

Conditions: Diabetes

Treatments: Drug: insulin glulisine, insulin aspart; Drug: insulin aspart, insulin glulisine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00969592

49-0361-GluAsp

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups

insulin glulisine, insulin aspart

Active Comparator group

Description:

insulin glulisine administration during first glucose clamp, insulin aspart administration during second glucose clamp

Treatment:

Drug: insulin glulisine, insulin aspart

insulin aspart, insulin glulisine

Active Comparator group

Description:

insulin aspart administration during first euglycemic clamp, insulin glulisine administration during second clamp

Treatment:

Drug: insulin aspart, insulin glulisine