Insulin Glargine Versus Twice-Daily NPH

Phase 4

Terminated

Interventions: Drug: Insulin glargine at bedtime instead of NPH
Drug: NPH twice-daily

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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 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.

Arm && Interventions

Group	Intervention	Description
Insulin glargine injected at bedtime	Insulin glargine at bedtime instead of NPH	Insulin glargine injected at bedtime
NPH insulin injected twice-daily	NPH twice-daily	NPH insulin injected twice-daily, before breakfast and at bedtime

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c Change From Baseline	Baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Any Adverse Event Other Than Hypoglycemia	6 months
Body Mass Index Change From Baseline	Baseline and 6 months
Frequency of Pre-supper Glucose Readings 130 mg/dL or Less, Change From Baseline	6 months
Frequency of Total Hypoglycemic Reactions	6 months
Frequency of Severe Hypoglycemic Reactions	6 months
Total Daily Insulin Dose	Baseline and 6 months