Insulin Glargine at Bedtime or in AM Versus NPH

Charles Drew University of Medicine and Science

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: 3 - NPH insulin QHS; Drug: 2 - Insulin glargine QAM; Drug: 1- Insulin glargine QHS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00686712

03-02-524

U54RR014616 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 months
• 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 diabetes)
• 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

1 - Insulin glargine QHS

Experimental group

Description:

Insulin glargine injected subcutaneously once daily at bedtime

Treatment:

Drug: 1- Insulin glargine QHS

2 - Insulin glargine QAM

Experimental group

Description:

Insulin glargine injected subcutaneously once daily in the morning

Treatment:

Drug: 2 - Insulin glargine QAM

3 - NPH Insulin QHS

Active Comparator group

Description:

NPH insulin injected subcutaneously once daily at bedtime

Treatment:

Drug: 3 - NPH insulin QHS