Insulin Glargine Versus Twice-Daily NPH

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. Identifier: NCT00687453
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : October 7, 2010
Last Update Posted : February 11, 2014
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science

Brief Summary:
To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly NPH insulin alone.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin glargine at bedtime instead of NPH Drug: NPH twice-daily Phase 4

Detailed Description:
Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when compared to twice-daily NPH insulin is not known when used in low-income ethnic minority patients. This study investigates whether insulin glargine may be more or less effective and safe than twice-daily NPH insulin in this population.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
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 on Combination Insulin-Oral Agent Therapy
Study Start Date : February 2003
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Insulin glargine at bedtime
Drug: Insulin glargine at bedtime instead of NPH
Insulin glargine at bedtime substituting for NPH insulin at bedtime
Other Name: Trade name: Lantus
Active Comparator: 2
NPH twice-daily
Drug: NPH twice-daily
Addition of morning NPH to bedtime NPH
Other Name: (Generic)

Primary Outcome Measures :
  1. Hemoglobin A1c Change From Baseline [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures :
  1. Frequency of Pre-supper Glucose Readings 120 mg/dL or Less [ Time Frame: 6 months ]
  2. Frequency of Total Hypoglycemic Reactions [ Time Frame: 6 months ]
  3. Frequency of Severe Hypoglycemic Reactions [ Time Frame: 6 months ]
  4. Body Mass Index Change From Baseline [ Time Frame: 6 months ]
  5. Total Daily Insulin Dose [ Time Frame: 6 months ]
  6. Any Adverse Event Other Than Hypoglycemia [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female, age 18-75
  • Type 2 diabetes diagnosed for at least 1 year
  • Inadequate glycemic control (hemoglobin A1c ≥ 7.5%) on stable and maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime injection of NPH insulin
  • Except for the subject's current bedtime NPH insulin, no other past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
  • Average fasting plasma glucose level <130 mg/dL without fasting hypoglycemia
  • Hemoglobin A1c between 7.5% and 12%
  • Body mass index (BMI) between 20 and 40 kg/m2

Exclusion Criteria:

  • 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 intensive insulin therapy is contraindicated
  • Subjects with advanced proliferative diabetic retinopathy
  • Subjects 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.

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 identifier (NCT number): NCT00687453

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

Responsible Party: Charles Drew University of Medicine and Science Identifier: NCT00687453     History of Changes
Other Study ID Numbers: 03-02-519
U54RR014616 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2008    Key Record Dates
Results First Posted: October 7, 2010
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Charles Drew University of Medicine and Science:
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
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs