Insulin Glargine Versus Twice-Daily NPH

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00687453
First received: May 27, 2008
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: Insulin glargine at bedtime instead of NPH
Drug: NPH twice-daily
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 on Combination Insulin-Oral Agent 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of Pre-supper Glucose Readings 120 mg/dL or Less [ 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: 27
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 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)

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.

  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
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687453

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

No publications provided

Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00687453     History of Changes
Other Study ID Numbers: 03-02-519, U54RR014616
Study First Received: May 27, 2008
Results First Received: September 15, 2010
Last Updated: February 7, 2014
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014