At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 188 enrolled
Drug / intervention
ORMD-0801 +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.
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Diet and Metformin
In Brief
A Phase 2 clinical trial evaluating ORMD-0801 and Placebo Comparator for Diabetes Type 2. Completed, enrolled 188 participants across 34 sites.
Detailed Summary
Randomized, double-blind, placebo-controlled, parallel group study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Type 2
CountriesUnited States
CollaboratorsIntegrium
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartJul 2015
Primary CompletionJun 2016
Study CompletionSep 2016
TodayJul 2026
First PostedJul 14, 2015
Enrollment StartJul 27, 2015
Primary CompletionJun 27, 2016
Study CompletionSep 13, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.0 years ago
Interventions
ORMD-0801drug
Oral Insulin
Placebo Comparatordrug
Placebo