Insulin Glargine at Bedtime or in AM Versus NPH

Phase 4

Completed

Interventions: Drug: 2 - Insulin glargine QAM
Drug: 1- Insulin glargine QHS
Drug: 3 - NPH insulin QHS

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
2 - Insulin glargine QAM	2 - Insulin glargine QAM	Insulin glargine injected subcutaneously once daily in the morning
1 - Insulin glargine QHS	1- Insulin glargine QHS	Insulin glargine injected subcutaneously once daily at bedtime
3 - NPH Insulin QHS	3 - NPH insulin QHS	NPH insulin injected subcutaneously once daily at bedtime

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Frequency of Severe Hypoglycemic Reactions	6 months	Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person
Frequency of Total Hypoglycemic Reactions	6 months	Frequency of hypoglycemic reactions without regard to time of occurrence
Body Mass Index Change From Baseline	6 months	Change in body mass index from baseline BMI measurement
Any Adverse Event Other Than Hypoglycemia	6 months	Any reported adverse event that is not hypoglycemia
Frequency of Glucose Readings < 130 mg/dL	6 months	Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL
Total Daily Insulin Dose	6 months	Total daily number of units of insulin used