At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,117 enrolled
Drug / intervention
Insulin lispro +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.
Two Approaches to Escalate Lispro Therapy in Patients With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone (AUTONOMY)
In Brief
A Phase 4 clinical trial evaluating Insulin lispro and Glargine for Diabetes Mellitus, Type 2. Completed, enrolled 1,117 participants across 76 sites in 15 countries.
Detailed Summary
Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Austria, Brazil, Canada, Croatia, Denmark, France, Lithuania, Mexico, Poland, Puerto Rico, Romania, Russia, South Africa, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartDec 2010
Primary CompletionJan 2013
TodayJul 2026
First PostedOct 7, 2010
Enrollment StartDec 1, 2010
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.7 years ago
Interventions
Insulin lisprodrug
Administered subcutaneously, up to three times daily for 24 weeks
Glarginedrug
Administered subcutaneously, dosage determined by investigator once daily for 24 weeks