Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes
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.
Diabetes Mellitus, Type 2
Drug: Lispro Mixture Therapy
Drug: Glargine Basal-Bolus Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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.
- 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.
|Study Start Date:||April 2004|
|Study Completion Date:||April 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110370
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|Study Director:||Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|