Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT04606576|
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : January 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Other: Placebo Drug: ORMD-0801 QD Drug: ORMD-0801 BD||Phase 3|
Screening Period Subjects will provide a written informed consent during Screening Visit 1. They will be scheduled to return to the clinic 10 days prior to randomization for Screening Visit 2. At this visit, a CGM sensor will be placed with appropriate instructions by the study team for a 10-day blinded CGM data collection by the site. Subjects will then return to the clinic after 10 days (± 1-day) for removal of the CGM sensor. The subjects will be randomized to one of the three arms of the study treatment.
3.1.2 26-Week Double-Blind Treatment Period After the Screening Period, subjects will be randomized to 26 weeks of the Double-Blind Treatment Period. In a double-blind, double dummy randomization scheme, subjects will either receive ORMD-0801 administered once-daily at night (1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner); or ORMD-0801 8 mg (1 x 8 mg capsule) administered twice daily, each morning approximately 45 minutes (±15 minutes) prior to breakfast and each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) or matching placebo. Subjects will receive 1 capsule approximately 45 minutes (±15 minutes) prior to breakfast and 1 capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner.
During the Double-Blind Treatment Period commencing at Week 0 (Visit 1, CGM removal), subjects will return to the clinic at the following intervals: Week 6 - Visit 2; Week 12 - Visit 3; Week 18 -Visit 4; Week 24 - Visit 5 (10 days (± 1-day) prior to Week 26 for CGM application) and Week 26 - Visit 6 (CGM removal and end of Double-Blind Treatment Period visit).
The visit requiring CGM application will occur 10 days prior to the CGM removal visit within ± 1-day window.
3.1.3 26-Week Double-Blind Treatment Extension Period Following the completion of the Double-Blind Treatment Period, subject will enter a 26-week Double-Blind Treatment Extension Period. Subjects previously randomized to placebo during the Double-Blind Treatment Period will be randomized to receive either ORMD-0801 8 mg QD or 8 mg BID for the duration of the Double-Blind Treatment Extension Period. Subjects previously randomized to 8 mg QD or 8 mg BID during the Double-Blind Treatment Period will remain in the same treatment arm for the duration of the Double-Blind Treatment Extension Period. The Extension Period treatment assignments will remain blinded for the duration of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||675 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||In this randomized, double-blind, double dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a 26-week Double-Blind Treatment Extension Period.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With T2DM With Inadequate Glycemic Control on 1, 2 or 3 Oral Glucose-lowering Agents.|
|Actual Study Start Date :||November 23, 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
Placebo Comparator: Placebo
Other Name: Fish Oil
Experimental: ORMD-0801 QD
8 mg ORMD-0801 administered QD at night
Drug: ORMD-0801 QD
Oral Insulin once per day
Other Name: Oral Insulin
Experimental: ORMD-0801 BID
8 mg ORMD-0801 administered at night and in the morning 45 minutes before breakfast.
Drug: ORMD-0801 BD
Oral Insulin, twice per day
Other Name: Oral Insulin
- Mean change from baseline in A1C [ Time Frame: Baseline and 26 Weeks ]The mean change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for the active and placebo groups.
- Mean change in fasting glucose [ Time Frame: Baseline and 26 weeks ]The Mean change from baseline (Visit 1) in fasting plasma glucose at 26 weeks (Visit 6) will be analyzed using a linear mixed model similar to the primary analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606576
|Contact: Kim Pope, RN, BSN||830-438-7162||Kim.Pope@integrium.com|
|United States, California|
|Orange County Research Center (OCRC) 14351 Myford Rd., Suite B, Tustin, CA 92780||Recruiting|
|Tustin, California, United States, 92780|
|Contact: Joel M Neutel, M. D. 714-541-5591 firstname.lastname@example.org|
|Contact: Carmen Margaritescu, M. D. +1 714 210 6665 email@example.com|
|Study Director:||Miriam Kidron, PhD||Oramed, Ltd.|