At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 135 enrolled
Drug / intervention
Lispro Mix 50/50drug
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.
The Study of Stepwise Introduction of Insulin Analog Mixture as a Post-marketing Clinical Trial of Lispro Mix 50/50 to Evaluate Efficacy and Safety in Type 2 Diabetic Patients With Inadequate Glycemic Control on Oral Therapy. (SIMPLE Study)
In Brief
A Phase 4 clinical trial evaluating Lispro Mix 50/50 for Diabetes Mellitus, Type 2. Completed, enrolled 135 participants across 14 sites.
Detailed Summary
The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic control on oral antidiabetic drugs (OADs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedSep 2009
Primary CompletionApr 2011
TodayJul 2026
First PostedSep 4, 2009
Enrollment StartSep 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.8 years ago
Interventions
Lispro Mix 50/50drug
Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control.