Insulin Glargine at Bedtime or in AM Versus NPH

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.

Inclusion Criteria:

- Male or female, age 18-75

- Type 2 diabetes diagnosed for at least 1 year

- Treatment with stable doses of oral agents (alone or in combination) for at least 2
months

- Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on maximum-tolerated doses of a
sulfonylurea, metformin and a thiazolidinedione

- No past history of chronic insulin use (other than treatment of gestational diabetes
or hospitalizations of less than 1 week in duration)

- Hemoglobin A1c between 7.5% and 12%

- Body mass index (BMI) between 20 and 40 kg/m2

Exclusion Criteria:

- Current or previous chronic use of insulin (other than for treatment of gestational
diabetes)

- 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 insulin therapy is contraindicated or for whom, in the opinion of
the investigator, therapy with insulin is not indicated

- Subjects with advanced proliferative diabetic retinopathy

- Subjects who work night shifts or 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
difficult.

- 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.