Glulisine Pre- and Postmeal - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00290043

Purpose

To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and RHI (HOE31HPR100) injected subcutaneously before and after a standard meal

Condition	Intervention	Phase
Diabetes Mellitus Type 1	Drug: Insulin glulisine	Phase I

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Insulin glulisine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Glucodynamic Response to Pre- and Postmeal Subcutaneous Injection of 0.15 IU/Kg HMR1964 Insulin and RHI in Type 1 Diabetic Subjects in an Open, Randomized, Four-Way Crossover Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological postprandial glucose disposal than RHI.

Estimated Enrollment:	20
Study Start Date:	December 2001
Estimated Study Completion Date:	March 2002

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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: NCT00290043

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:

Klaus Rave, Dr.

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	HMR1964-1008, HMR1964
Study First Received:	February 9, 2006
Last Updated:	February 9, 2006
ClinicalTrials.gov Identifier:	NCT00290043
Health Authority:	Germany: Ethics Commission

Keywords provided by Sanofi-Aventis:

Insulin glulisine
Diabetes mellitus Type 1
Postprandial Period
Pharmacokinetics
Glucodynamics

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Insulin glulisine
Diabetes Mellitus
Endocrine System Diseases
Insulin
Naphazoline
Oxymetazoline

Diabetes Mellitus, Type 1
Guaifenesin
Phenylephrine
Endocrinopathy
Phenylpropanolamine
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009