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

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 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.

Official Title
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The Utility of Insulin Glargine (Lantus) Compared to NPH in Ethnic Minority Type 2 Diabetic Subjects Starting Insulin Therapy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: 1- Insulin glargine QHS
* Drug: 2 - Insulin glargine QAM
* Drug: 3 - NPH insulin QHS


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 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.

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: 1 - Insulin glargine QHS<br>Insulin glargine injected subcutaneously once daily at bedtime | Drug: 1- Insulin glargine QHS<br>* Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings <120 mg/dL)<br>* Other names: Trade name: Lantus;|
| Experimental: 2 - Insulin glargine QAM<br>Insulin glargine injected subcutaneously once daily in the morning | Drug: 2 - Insulin glargine QAM<br>* Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings <120 mg/dL)<br>* Other names: Trade name: Lantus;|
| Active Comparator: 3 - NPH Insulin QHS<br>NPH insulin injected subcutaneously once daily at bedtime | Drug: 3 - NPH insulin QHS<br>* NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses <120 mg/dL)<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 Glucose Readings < 130 mg/dL | Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL | 6 months | 
| Frequency of Total Hypoglycemic Reactions | Frequency of hypoglycemic reactions without regard to time of occurrence | 6 months | 
| Frequency of Severe Hypoglycemic Reactions | Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person | 6 months | 
| Body Mass Index Change From Baseline | Change in body mass index from baseline BMI measurement | 6 months | 
| Total Daily Insulin Dose | Total daily number of units of insulin used | 6 months | 
| Any Adverse Event Other Than Hypoglycemia | Any reported adverse event that is not 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