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Sponsored by: |
Eli Lilly and Company |
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00494013 |
The purpose of this study is to examine the effectiveness and safety of lispro suspension as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Condition | Intervention | Phase |
Diabetes Mellitus Type 2 |
Drug: Insulin Lispro Protamine Suspension Drug: Detemir |
Phase III |
MedlinePlus related topics: | Diabetes |
Drug Information available for: | Insulin Insulin lispro Protamine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus |
Enrollment: | 377 |
Study Start Date: | August 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Insulin Lispro Protamine Suspension
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Drug: Insulin Lispro Protamine Suspension
Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
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2: Active Comparator
Detemir
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Drug: Detemir
Patient specific dose administered subcutaneously once daily x 24 weeks.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Show 56 Study Locations |
Eli Lilly and Company |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Lilly Clinical Trial Registry 
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Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 10935, F3Z-MC-IOOY |
First Received: | June 27, 2007 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00494013 |
Health Authority: | United States: Food and Drug Administration |
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