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Insulin Glargine at Bedtime or in AM Versus NPH

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686712
First Posted: May 30, 2008
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science
  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: 1- Insulin glargine QHS Drug: 2 - Insulin glargine QAM Drug: 3 - NPH insulin QHS Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Frequency of Glucose Readings < 130 mg/dL [ Time Frame: 6 months ]
    Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL

  • Frequency of Total Hypoglycemic Reactions [ Time Frame: 6 months ]
    Frequency of hypoglycemic reactions without regard to time of occurrence

  • Frequency of Severe Hypoglycemic Reactions [ Time Frame: 6 months ]
    Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person

  • Body Mass Index Change From Baseline [ Time Frame: 6 months ]
    Change in body mass index from baseline BMI measurement

  • Total Daily Insulin Dose [ Time Frame: 6 months ]
    Total daily number of units of insulin used

  • Any Adverse Event Other Than Hypoglycemia [ Time Frame: 6 months ]
    Any reported adverse event that is not hypoglycemia


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 QHS
Insulin glargine injected subcutaneously once daily at bedtime
Drug: 1- Insulin glargine QHS
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 QAM
Insulin glargine injected subcutaneously once daily in the morning
Drug: 2 - Insulin glargine QAM
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 QHS
NPH insulin injected subcutaneously once daily at bedtime
Drug: 3 - NPH insulin QHS
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: September 15, 2010
Results First Posted: October 7, 2010
Last Update Posted: May 22, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs