NCT00686712

Insulin Glargine at Bedtime or in AM Versus NPH

The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Charles Drew University of Medicine and Science · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	1- Insulin glargine QHS	Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \<120 mg/dL)
DRUG	2 - Insulin glargine QAM	Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \<120 mg/dL)
DRUG	3 - NPH insulin QHS	NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \<120 mg/dL)

Timeline

• Start date: 2003-02-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-05-30
• Last updated: 2017-05-22
• Results posted: 2010-10-07

Locations

1 site across 1 country: United States