Expanded PK and PD of Insulin Glulisine Versus Insulin Aspart in Healthy Volunteers
This study has been completed.
Sponsor:
Profil Institut für Stoffwechselforschung GmbH
Collaborator:
Sanofi
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT00969592
First received: August 31, 2009
Last updated: September 1, 2009
Last verified: September 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes |
Drug: insulin glulisine, insulin aspart Drug: insulin aspart, insulin glulisine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Comparison of Pharmacodynamics and Pharmacokinetics of the Two Fast-acting Insulin Analogs Insulin Glulisine and Insulin Aspart in Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:
Primary Outcome Measures:
- fractional and total glucose infusion rates [ Time Frame: 0-1 hours, 0-2 hours, and time to 10% of GIRmax ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- fractional and total insulin areas under the curve (AUC) [ Time Frame: 0-1 hours, 0-2 hours, 0-10 hours ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | November 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: insulin glulisine, insulin aspart
insulin glulisine administration during first glucose clamp, insulin aspart administration during second glucose clamp
|
Drug: insulin glulisine, insulin aspart
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
Other Names:
|
|
Active Comparator: insulin aspart, insulin glulisine
insulin aspart administration during first euglycemic clamp, insulin glulisine administration during second clamp
|
Drug: insulin aspart, insulin glulisine
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
Other Names:
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969592
Locations
| Germany | |
| Profil Institut für Stoffwechselforschung GmbH | |
| Neuss, Germany, D-41460 | |
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Sanofi
Investigators
| Principal Investigator: | Sabine Arnolds, MD | Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany |
More Information
No publications provided
| Responsible Party: | Christoph Kapitza, MD, Profil Institut für Stoffwechselforschung GmbH |
| ClinicalTrials.gov Identifier: | NCT00969592 History of Changes |
| Other Study ID Numbers: | 49-0361-GluAsp |
| Study First Received: | August 31, 2009 |
| Last Updated: | September 1, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
|
diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart |
Insulin glulisine Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013