Conditions: Type 2 Diabetes Mellitus
Keywords: Glargine Type 2 diabetes Basal insulin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 108
Healthy volunteers: no

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.

Arms:
arm 1: Insulin glargine injected subcutaneously once daily at bedtime arm 2: Insulin glargine injected subcutaneously once daily in the morning arm 3: NPH insulin injected subcutaneously once daily at bedtime

Interventions: intervention 1: 1- Insulin glargine QHS intervention 2: 2 - Insulin glargine QAM intervention 3: 3 - NPH insulin QHS
Intervention descriptions: intervention 1: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \<120 mg/dL) intervention 2: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \<120 mg/dL) intervention 3: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \<120 mg/dL)

Protocol document: