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Insulin Glargine at Bedtime or in AM Versus 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 (Drug); Insulin glargine (Drug); NPH insulin (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 a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.

Clinical Details

Official title: The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin 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 Glucose Readings < 130 mg/dL

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 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.


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

- Treatment with stable doses of oral agents (alone or in combination) for at least 2


- 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


- 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


- 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: March 25, 2013

Page last updated: August 23, 2015

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