Insulin Glargine Versus Twice-Daily NPH

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects on Combination Insulin-Oral Agent Therapy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin glargine at bedtime instead of NPH
* Drug: NPH twice-daily


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin glargine injected at bedtime<br>Insulin glargine injected at bedtime | Drug: Insulin glargine at bedtime instead of NPH<br>* Insulin glargine at bedtime substituting for NPH insulin at bedtime<br>* Other names: Trade name: Lantus;|
| Active Comparator: NPH insulin injected twice-daily<br>NPH insulin injected twice-daily, before breakfast and at bedtime | Drug: NPH twice-daily<br>* Addition of morning NPH to bedtime NPH<br>* Other names: (Generic);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c Change From Baseline |  | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Pre-supper Glucose Readings 130 mg/dL or Less, Change From Baseline |  | 6 months | 
| Frequency of Total Hypoglycemic Reactions |  | 6 months | 
| Frequency of Severe Hypoglycemic Reactions |  | 6 months | 
| Body Mass Index Change From Baseline |  | Baseline and 6 months | 
| Total Daily Insulin Dose |  | Baseline and 6 months | 
| Any Adverse Event Other Than Hypoglycemia |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glargine, Type 2 diabetes, Basal insulin