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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Anniston, Alabama, United States
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Concord, California, United States
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Inglewood, California, United States
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La Jolla, California, United States
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Orange, California, United States
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West Hills, California, United States
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Colorado Springs, Colorado, United States
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Aventura, Florida, United States
...and 38 more locations