At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
ORMD-0801 Dose # 1 +2 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, PK and PD of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With T2DM Who Are Inadequately Controlled With Diet and Exercise or Diet, Exercise and Metformin
In Brief
A Phase 2 clinical trial evaluating ORMD-0801 Dose # 1, ORMD-0801 Dose # 2, and 1 other intervention for Diabetes Mellitus Type 2. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The purpose of this study is to test the safety and pharmacodynamics of an oral formulation of insulin in subjects with Type 2 Diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus Type 2
CountriesUnited States
CollaboratorsIntegrium
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJun 2013
Primary CompletionNov 2013
TodayJul 2026
First PostedJun 28, 2013
Enrollment StartJun 1, 2013
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.0 years ago
Interventions
ORMD-0801 Dose # 1drug
Oral Insulin Formulation
ORMD-0801 Dose # 2drug
Oral Insulin Formulation
Placebodrug
Oil Capsules