At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 113 enrolled
Drug / intervention
OPK-88003 +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.
A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes
In Brief
A Phase 2 clinical trial evaluating OPK-88003 and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 113 participants across 3 sites.
Detailed Summary
This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartApr 2018
Primary CompletionMar 2019
Study CompletionJun 2019
TodayJul 2026
First PostedJan 23, 2018
Enrollment StartApr 2, 2018
Primary CompletionMar 8, 2019
Study CompletionJun 27, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.4 years ago
Interventions
OPK-88003drug
OPK-88003 subcutaneous injection
Placebodrug
Placebo subcutaneous injection