Dose-Exposure-Response in Type 1 Diabetes Mellitus - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00368394

Purpose

To investigate the dose-exposure-response relationship of insulin glulisine (HMR1964) after single subcutaneous injections of 0.075, 0.15 and 0.3 U/kg body weight with the euglycaemic clamp technique using the Biostator (TM).

Condition	Intervention	Phase
Diabetes Mellitus, Type I	Drug: Insulin glulisine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Dose-Exposure-Response Relationship of Insulin Glulisine (HMR1964) in Subjects With Type 1 Diabetes Mellitus Assessed With the Euglycemic Clamp Technique Using the Biostator (TM)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin glulisine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Outcome measures: Glucose infusion rate, insulin concentrations.
Outcome:In T1DM, glulisine, like RHI, displays dose proportionality in exposure over the dose range 0.075 to 0.3 U/kg, which partly only translates into dose proportionality in glucodynamics.

Estimated Enrollment:	18
Study Start Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 diabetes mellitus

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368394

Locations

Germany
Sanofi-Aventis
Neuss, Germany

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Klaus Rave Dr, med

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	HMR1964/1019, HMR1964
Study First Received:	August 23, 2006
Last Updated:	August 23, 2006
ClinicalTrials.gov Identifier:	NCT00368394 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Sanofi-Aventis:

Insulin glulisine
Euglycaemic clamp
Diabetes mellitus Type 1

Study placed in the following topic categories:

Hypoglycemic Agents
Insulin glulisine
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Insulin glulisine
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on August 12, 2009