Insulin Glargine at Bedtime or in AM Versus NPH - Full Text View

Purpose

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

MedlinePlus related topics:

Diabetes

Drug Information available for:

Insulin Insulin glargine Dextrose Insulin, isophane Benzocaine

U.S. FDA Resources

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

Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:

Hemoglobin A1c change from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of glucose readings < 130 mg/dL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Frequency of total hypoglycemic reactions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Frequency of severe hypoglycemic reactions [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Body mass index change from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Total daily insulin dose [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Any adverse event other than hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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)
3: Active Comparator NPH insulin	Drug: NPH insulin NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686712

Contacts


Contact: Veronica Aguilar	323-357-3634	veronicaaguilar@cdrewu.edu

Locations


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

Sponsors and Collaborators

Charles Drew University of Medicine and Science

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Stanley Hsia, MD	Charles Drew University of Medicine and Science

More Information

Responsible Party:	Charles Drew University of Medicine and Science ( Stanley Hsia, MD )
Study ID Numbers:	03-02-524
First Received:	May 27, 2008
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00686712
Health Authority:	United States: Institutional Review Board

Keywords provided by Charles Drew University of Medicine and Science:

Glargine

Type 2 diabetes

Basal insulin

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Benzocaine

Glargine

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin, Isophane

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 02, 2008

Sponsors and Collaborators:	Charles Drew University of Medicine and Science National Institutes of Health (NIH)
Information provided by:	Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:	NCT00686712