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.
- Male or female, age 18-75
- Type 2 diabetes diagnosed for at least 1 year
- Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on stable and maximum-tolerated
doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime
injection of NPH insulin
- Except for the subject's current bedtime NPH insulin, no other past history of
chronic insulin use (other than treatment of gestational diabetes or hospitalizations
of less than 1 week in duration)
- Average fasting plasma glucose level <130 mg/dL without fasting hypoglycemia
- Hemoglobin A1c between 7.5% and 12%
- Body mass index (BMI) between 20 and 40 kg/m2
- History of confirmed (or clinical suspicion of ) type 1 diabetes
- Female subjects of childbearing potential who are sexually active and not using a
reliable form of contraception.
- Current pregnancy or lactation.
- Subjects for whom intensive insulin therapy is contraindicated
- Subjects with advanced proliferative diabetic retinopathy
- Subjects who are unable to stay on a consistent daily meal schedule
- History of any clinically significant renal, hepatic, cardiovascular, neurological,
endocrinological or other major systemic disease that, in the opinion of the
investigator, may make implementation of the protocol or interpretation of the data
- Subjects who will likely require or initiate therapy with drugs which may interfere
with glucose metabolism during the course of the study
- Subjects who are in another investigational study or have received another
investigational medication within 30 days of study entry
- Subjects who are unable or unwilling to comply with all components of the study
protocol, including contacting the investigators at specified times and attending all
scheduled follow-up visits.