At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
SPIL1033 +1 moredrug
Likely dose
SPIL1033 5 mcgfrom 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.
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating SPIL1033 and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 360 participants across 34 sites.
Detailed Summary
SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartMar 2013
Primary CompletionNov 2015
TodayJul 2026
First PostedAug 1, 2011
Enrollment StartMar 1, 2013
Primary CompletionNov 4, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.9 years ago
Interventions
SPIL1033drug
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
Placebodrug
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.