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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00552370 |
To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of -study target for self monitored plasma glucose(SMPG), in patients with Type 2 diabetes mellitis, with inadequate glycemic control (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).
Condition | Intervention | Phase |
Diabetes Mellitus, Type 2 |
Drug: Lantus® |
Phase IV |
MedlinePlus related topics: | Diabetes Hypoglycemia |
ChemIDplus related topics: | Insulin Insulin glargine Dextrose |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Glycemia Optimization Treatment: Safety of Glucose Control Using Dosing Algorithms With Lantus®(Insulin Glargine [rDNA Origin[) in Adult Individuals With Type 2 Diabetes. |
Enrollment: | 5056 |
Study Start Date: | March 2003 |
Study Completion Date: | February 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
clinicalstudyresults.org 
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Responsible Party: | sanofi-aventis ( Study Director ) |
Study ID Numbers: | HOE901_4045 |
First Received: | October 31, 2007 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00552370 |
Health Authority: | United States: Institutional Review Board |
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