Statistically Significant Results Across Key Glycemic Endpoints
Conference Call Today at 11:00 AM ET
“ORMD-0801 was safe and efficacious in reducing blood glucose endpoints with a promising clinically meaningful reduction in the mean 24-hour blood glucose,” said Dr.
The primary objective of the study was to evaluate the nighttime glucose lowering effect and safety of ORMD-0801 compared to a placebo. Excessive production of glucose at night is a significant challenge in diabetes management. Reducing nighttime blood glucose levels can significantly slow down the progression of diabetes and its life threatening comorbidities.
In the study, the mean nighttime glucose showed a significant difference in mean change from run-in (13.70 mg/dL for placebo vs. 1.66 mg/dL for the pooled ORMD-0801 arms with a p= 0.0117). ORMD-0801 was safe and well tolerated, with no drug related serious or severe adverse events and no statistically significant differences in laboratory values or vital signs.
Other secondary and exploratory objectives of the study included evaluating the effect of ORMD-0801 on mean 24-hour glucose, fasting glucose, and daytime glucose. The mean 24-hour glucose showed a highly significant difference in mean change from run-in (13.26 mg/dL for placebo vs. -0.32 mg/dL for ORMD-0801, p <0.0001). The mean fasting glucose showed a highly significant difference in mean change from run-in (15.95 mg/dL for placebo vs. -0.41 mg/dL for ORMD-0801, p <0.0001). The mean daytime CGM glucose showed a highly significant difference in mean change from run-in (11.88 for placebo vs. 0.88 for ORMD-0801, p= 0.0010).
There was a statistically significant difference in change in HbA1c at Day 29 (0.20% for placebo vs.-0.01% for ORMD-0801, p= 0.0149). It is important to note that due to the kinetics of change of HbA1c, a four week study is insufficient to fully appreciate the potential positive impact of ORMD-0801 on HbA1c.
ORMD-0801 did not show a significant difference in change in morning fasting serum insulin, C-Peptide, or triglycerides.
A conference call on the results of the Phase IIb study will be held today,
To participate, please call:
About the Study [ORA-D-007]
The randomized, double-blind Phase IIb study was conducted in 33 sites across
For more information on the study, which does not form a part of this press release, see: https://clinicaltrials.gov/ct2/show/NCT02496000?term=oramed&rank=5
About ORMD-0801 Capsule for Type 2 Diabetes
Intestinally-absorbed oral insulin mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream. ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or eliminating late-stage complications. Orally administered insulin is also expected to enhance patient compliance.
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss that our
US: +1-718-831-2512 ext. 2