Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04606576
Status:
TERMINATED
Last Update Posted:
2023-02-09
First Post:
2020-10-22
Brief Title:
Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus
Sponsor:
Oramed Ltd
Organization:
Oramed Ltd
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
ORA-D-013-1 was terminated based on the primary results analyzed at the end of the treatment week 26
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
312 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
313 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
312 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
313 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None