Glycemic Optimization Treatment Study
NCT00552370 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5062
Last updated 2009-07-21
Summary
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 mellitus, with inadequate glycemic control (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Lantus®
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Karen Barch · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
- Primary Completion
- 2005-03-31
- Completion
- 2005-03-31
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