Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754334
Status:
TERMINATED
Last Update Posted:
2023-02-09
First Post:
2021-02-08
Brief Title:
A Phase 3 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-Blind Placebo-controlled Multi-center Randomized Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in T2DM Subjects With Inadequate Glycemic Control on Diet Control Only or on Diet Control and Metformin Monotherapy
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The ORA-D-013-2 protocol was terminated based on the primary results analyzed at week 26 in the ORA-D-013-1 protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy Subjects will undergo an initial 21-day Screening Period followed by a 26-week Double-Blind Treatment Period and a Double-Blind 26-week Treatment Extension Period
Detailed Description:
Screening Period The investigator will review the aim of the study study procedures potential risks and benefits with the volunteers These subjects will then sign a written informed consent during Screening Visit 1 They will be instructed to return to the clinic 10 days prior to randomization Visit 1 for Screening Visit 2 At this visit a continuous glucose monitoring 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 study treatment arms
26-Week Double-Masked Treatment Period After the Screening Period subjects will be randomized to 26 weeks of the Double-Blind Treatment Period consisting of ORMD-0801 8 mg 1 x 8 mg capsule or placebo in a 11 randomized fashion Medication will be administered once daily at night prior to bedtime between 8 PM to 12 Midnight and no sooner than 1 hour after dinner
During the Double-Masked 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 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 a 1-day window
26-Week Double-Masked Treatment Extension Period Following the completion of the Double-Blind Treatment Period subjects will enter a 26-week Double-Blind Treatment Extension Period Subjects will remain on the same treatment regimen and continue to receive the same medication for the duration of the Double-Blind Treatment Extension Period The Extension Period treatment assignments will remain blinded for the duration of the study
Visits will occur at the following intervals during the 26-Week Double-Masked Treatment Extension Period Week 30 - Visit 7 Week 40 - Visit 8 Week 50 - Visit 9 10 days prior to Week 52 for CGM application and Week 52 - Visit 10 CGM removal and end of Double-Blind Treatment Extension Period visit
The visit requiring CGM application will occur 10 days prior to the CGM removal visit within a 1-day window
All subjects completing the trial will return to the clinic in 2 weeks 3 days for a Safety Follow-Up Visit Subjects withdrawing prematurely from the trial will have the early termination ET visit procedures completed All patients will continue to be followed in accordance with ITT principles to avoid a loss to follow-up and missing data
26-Week Double-Masked Treatment Period After the Screening Period subjects will be randomized to 26 weeks of the Double-Blind Treatment Period consisting of ORMD-0801 8 mg 1 x 8 mg capsule or placebo in a 11 randomized fashion Medication will be administered once daily at night prior to bedtime between 8 PM to 12 Midnight and no sooner than 1 hour after dinner
During the Double-Masked 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 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 a 1-day window
26-Week Double-Masked Treatment Extension Period Following the completion of the Double-Blind Treatment Period subjects will enter a 26-week Double-Blind Treatment Extension Period Subjects will remain on the same treatment regimen and continue to receive the same medication for the duration of the Double-Blind Treatment Extension Period The Extension Period treatment assignments will remain blinded for the duration of the study
Visits will occur at the following intervals during the 26-Week Double-Masked Treatment Extension Period Week 30 - Visit 7 Week 40 - Visit 8 Week 50 - Visit 9 10 days prior to Week 52 for CGM application and Week 52 - Visit 10 CGM removal and end of Double-Blind Treatment Extension Period visit
The visit requiring CGM application will occur 10 days prior to the CGM removal visit within a 1-day window
All subjects completing the trial will return to the clinic in 2 weeks 3 days for a Safety Follow-Up Visit Subjects withdrawing prematurely from the trial will have the early termination ET visit procedures completed All patients will continue to be followed in accordance with ITT principles to avoid a loss to follow-up and missing data
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