Insulin Glargine Versus Twice-Daily NPH

Stopped early · Phase 4

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00687453

Run by

Charles Drew University of Medicine and Science

People needed

27

Starts

2003-02-01

Expected to finish

2009-08-01

Last updated by the study team

2023-11-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Charles Drew University of Medicine and Science — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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