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Sponsors and Collaborators: |
Charles Drew University of Medicine and Science National Institutes of Health (NIH) |
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Information provided by: | Charles Drew University of Medicine and Science |
ClinicalTrials.gov Identifier: | NCT00686712 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Insulin glargine Drug: NPH insulin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy |
Estimated Enrollment: | 129 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Insulin glargine at bedtime
|
Drug: Insulin glargine
Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)
|
2: Experimental
Insulin glargine at AM
|
Drug: Insulin glargine
Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)
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3: Active Comparator
NPH insulin
|
Drug: NPH insulin
NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Veronica Aguilar | 323-357-3634 | veronicaaguilar@cdrewu.edu |
United States, California | |
Charles Drew University of Medicine and Science | Recruiting |
Los Angeles, California, United States, 90059 | |
Principal Investigator: Stanley Hsia, MD | |
Sub-Investigator: Mayer Davidson, MD |
Principal Investigator: | Stanley Hsia, MD | Charles Drew University of Medicine and Science |
Responsible Party: | Charles Drew University of Medicine and Science ( Stanley Hsia, MD ) |
Study ID Numbers: | 03-02-524 |
Study First Received: | May 27, 2008 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00686712 |
Health Authority: | United States: Institutional Review Board |
Glargine Type 2 diabetes Basal insulin |
Metabolic Diseases Diabetes Mellitus, Type 2 Benzocaine Glargine Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin, Isophane Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |