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Sponsored by: |
Medical University of Graz |
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Information provided by: | Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT00810589 |
Clinical pharmacology trials investigating insulin detemir in subjects with type 1 diabetes have shown a prolonged and reproducible action profile of insulin detemir compared with NPH insulin and insulin glargine.
Duration of action of insulin detemir has been reported to be up to 24 hours.9,10,11 It has, however, been proposed that the mean duration of action is underestimated in glucose clamps lasting only 24 hours. This is so because a duration of action longer than 24 hours in individual clamps will be set to 24 hours in the mean calculation, whereas a shorter duration of action in individual clamps will be set to the true value.
It has been shown in clinical pharmacology trials that NPL insulin has an action profile comparable to NPH insulin in subjects with type 1 diabetes. , However, a direct comparison of pharmacodynamic properties of insulin detemir and NPL insulin has not been performed to date. To get further insight into the pharmacodynamic properties of insulin detemir compared with NPL insulin, this trial has been designed to compare pharmacodynamics in general and duration of action in particular between insulin detemir and NPL insulin in subjects with type 1 diabetes.
Condition | Intervention | Phase |
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Diabetes, Type I |
Drug: Levemir Drug: Humalog NPL Insulin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Randomised, Single Centre, Double-Blind, Two-Period Crossover, Glucose Clamp Trial to Compare the Pharmacodynamic Effects of Single Doses of Insulin Detemir and Neutral Protamin Lispro (NPL) Insulin in Subjects With Type 1 Diabetes |
Enrollment: | 30 |
Study Start Date: | November 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Levemir
0,4 IE per kg bodyweight
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2: Active Comparator |
Drug: Humalog NPL Insulin
0,4 IE per kg bodyweight
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Primary objective:
The primary objective is to compare the pharmacodynamic response of insulin detemir and NPL insulin with respect to duration of action in a 32-hour euglycaemic glucose clamp experiment following single dose administration in subjects with type 1 diabetes.
Secondary objectives:
The secondary objectives are:
Trial design:
This is a randomised, single centre, double-blind, two-period crossover trial. Each subject will be randomly allocated to two single dose administrations on two separate dosing visits.
Trial population:
Thirty (30) male and female subjects with type 1 diabetes [age 18-65 years (incl.) and body mass index between 18.0 and 32.0 kg/m2 (incl.)] will be randomised into the trial.
Assessments:
Pharmacodynamics: The glucose infusion rate and plasma glucose concentration will be measured during a euglycaemic glucose clamp running for 32 hours after dosing. Pharmacokinetics: Serum concentrations of insulin detemir and insulin lispro will be measured frequently during the first 32 hours after dosing. Safety: Adverse events, laboratory safety variables (haematology, biochemistry, urinalysis), physical examination, vital signs and hypoglycaemic episodes.
Trial products:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria
Austria | |
Medical University Graz | |
Graz, Austria, 8036 |
Study Director: | Thomas R. Pieber, MD | Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine |
Responsible Party: | Medical University Graz, Internal Medicine, Endocrinology and Nuclear Medicine ( Univ. Prof. Dr. Thomas Pieber ) |
Study ID Numbers: | ENM-HS-001 |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00810589 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety |
Metabolic Diseases Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Insulin LISPRO Diabetes Mellitus Type 1 Insulin |
Hypoglycemic Agents Diabetes Mellitus, Type 1 Endocrinopathy Protamines Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 Physiological Effects of Drugs |
Diabetes Mellitus Insulin LISPRO Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |