Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)
NCT00562172 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2012-07-17
Summary
Primary objective:
To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients
Secondary objective:
To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment
Conditions
Interventions
- DRUG
-
Insulin glargine
Once daily in the morning
- DRUG
-
Glimepiride
Once daily in the morning
- DRUG
-
At least 1000 mg/day
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Ji Young Ahn · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-09-30
- Primary Completion
- 2010-10-31
- Completion
- 2010-10-31
Countries
- South Korea
Study Locations
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