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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00174681 |
Primary objective:
The primary objective of this trial is:
Secondary objectives:
The secondary objectives of this trial are to compare between the two treatment groups:
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: Insulin Glargine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes |
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
Subjects fulfilling all of the following criteria will be eligible for inclusion in the trial:
Exclusion Criteria:
Patient with any of the following criteria will not be included in the trial:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Croatia | |
Sanofi-Aventis | |
Zagreb, Croatia | |
Czech Republic | |
Sanofi-Aventis | |
Prague, Czech Republic | |
France | |
Sanofi-Aventis | |
Paris, France | |
Romania | |
Sanofi-Aventis | |
Bucharest, Romania | |
Russian Federation | |
Sanofi-Aventis | |
Moscow, Russian Federation | |
Slovenia | |
Sanofi-Aventis | |
Ljubljana, Slovenia |
Study Director: | Valérie Pilorget, MD | Sanofi-Aventis |
Study ID Numbers: | HOE901/4042 |
Study First Received: | September 9, 2005 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00174681 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |