To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.
Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat. This study investigates whether insulin glargine may be a more effective or safer first-line basal insulin than NPH in this population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \<120 mg/dL)
Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \<120 mg/dL)
NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \<120 mg/dL)
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 Glucose Readings < 130 mg/dL
Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL
Time frame: 6 months
Frequency of Total Hypoglycemic Reactions
Frequency of hypoglycemic reactions without regard to time of occurrence
Time frame: 6 months
Frequency of Severe Hypoglycemic Reactions
Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person
Time frame: 6 months
Body Mass Index Change From Baseline
Change in body mass index from baseline BMI measurement
Time frame: 6 months
Total Daily Insulin Dose
Total daily number of units of insulin used
Time frame: 6 months
Any Adverse Event Other Than Hypoglycemia
Any reported adverse event that is not hypoglycemia
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.