To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly NPH insulin alone.
Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when compared to twice-daily NPH insulin is not known when used in low-income ethnic minority patients. This study investigates whether insulin glargine may be more or less effective and safe than twice-daily NPH insulin in this population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Insulin glargine at bedtime substituting for NPH insulin at bedtime
Addition of morning NPH to bedtime NPH
Charles Drew University of Medicine and Science
Los Angeles, California, United States
Hemoglobin A1c Change From Baseline
Time frame: Baseline to 6 months
Frequency of Pre-supper Glucose Readings 130 mg/dL or Less, Change From Baseline
Time frame: 6 months
Frequency of Total Hypoglycemic Reactions
Time frame: 6 months
Frequency of Severe Hypoglycemic Reactions
Time frame: 6 months
Body Mass Index Change From Baseline
Time frame: Baseline and 6 months
Total Daily Insulin Dose
Time frame: Baseline and 6 months
Any Adverse Event Other Than Hypoglycemia
Time frame: 6 months
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