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Insulin Glargine Versus Twice-Daily NPH

Information source: Charles Drew University of Medicine and Science
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Insulin glargine at bedtime instead of NPH (Drug); NPH twice-daily (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Charles Drew University of Medicine and Science

Official(s) and/or principal investigator(s):
Stanley Hsia, MD, Principal Investigator, Affiliation: Charles Drew University of Medicine and Science


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Hemoglobin A1c Change From Baseline

Secondary outcome:

Frequency of Pre-supper Glucose Readings 120 mg/dL or Less

Frequency of Total Hypoglycemic Reactions

Frequency of Severe Hypoglycemic Reactions

Body Mass Index Change From Baseline

Total Daily Insulin Dose

Any Adverse Event Other Than Hypoglycemia

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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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.

Locations and Contacts

Charles Drew University of Medicine and Science, Los Angeles, California 90059, United States
Additional Information

Starting date: February 2003
Last updated: February 7, 2014

Page last updated: August 23, 2015

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