At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 442 enrolled
Drug / intervention
Insulin Lispro Protamine Suspension +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Insulin Lispro Protamine Suspension and Detemir for Diabetes Mellitus Type 2. Completed, enrolled 442 participants across 56 sites in 9 countries.
Detailed Summary
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus Type 2
CountriesArgentina, Hungary, India, Mexico, Poland, South Korea, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2007
Enrollment StartAug 2007
Primary CompletionSep 2008
TodayJul 2026
First PostedJun 29, 2007
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.0 years ago
Interventions
Insulin Lispro Protamine Suspensiondrug
Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
Detemirdrug
Patient specific dose administered subcutaneously once or twice daily x 24 weeks.