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Insulin Glargine at Bedtime or in AM Versus NPH

This study has been completed.
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00686712
First received: May 27, 2008
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Hemoglobin A1c Change From Baseline [ Time Frame: Baseline to 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 ]

Enrollment: 108
Study Start Date: February 2003
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Insulin glargine at bedtime
 Drug: Insulin glargine
Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)
Other Name: Trade name: Lantus
Experimental: 2
Insulin glargine at AM
 Drug: Insulin glargine
Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)
Other Name: Trade name: Lantus
Active Comparator: 3
NPH insulin
 Drug: NPH insulin
NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)
Other Name: (Generic)

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

Locations
United States, California
Charles Drew University of Medicine and Science
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Stanley Hsia, MD Charles Drew University of Medicine and Science
  More Information

No publications provided by Charles Drew University of Medicine and Science

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00686712     History of Changes
Other Study ID Numbers: 03-02-524, U54RR014616
Study First Received: May 27, 2008
Results First Received: September 15, 2010
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Charles Drew University of Medicine and Science:
Glargine
Type 2 diabetes
Basal insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013