Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.

Official Title
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A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Lispro Mixture Therapy
* Drug: Glargine Basal-Bolus Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have type 2 diabetes. Must be 30-75 years of age at the time of Visit 1. Must be on insulin glargine and oral antidiabetic medicines for at least 90 days. Must be on at least 30 units of glargine per day at enrollment. Have an A1C between 7.5% and 12.0% at Visit 1. Exclusion Criteria: Must not have used rapid/short-acting insulin on a regular basis in the last 6 months. Must not have more than one episode of severe hypoglycemia in the last 6 months. Must not have a body mass index (BMI) of greater than 45 (morbid obesity). Must not have congestive heart failure that requires medications. Must not have had a kidney transplant or currently receiving dialysis

Ages Eligible for Study
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Minimum Age: 30 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lispro Mixture Therapy|nan|
|Drug: Glargine Basal-Bolus Therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior |  |  | 
| in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination |  |  | 
| with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal |  |  | 
| (A1C less than 7%) with once-daily insulin glargine in combination with OADs. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test in both arms the following: frequency and incidence |  |  | 
| of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose, |  |  | 
| body weight, SAE's and study drug related AEs. |  |  |