Date: 2016-05-18
Type of
information: Results
phase: 2b
Announcement: results
Company: Oramed Pharmaceuticals (Israel)
Product: oral insulin ORMD-0801
Action
mechanism: protein. ORMD-0801is an orally administered insulin.
Disease: type 2 diabetes
Therapeutic
area: Metabolic diseases
Country: USA
Trial
details: This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel group study. After appropriate screening, approximately 180 male and female patients from up to 33 study centers will be treated in this study. Patients with type 2 diabetes mellitus who are being treated by diet, exercise, untreated with antidiabetic medications or treated with and metformin monotherapy or in combination with one other antidiabetic drug (excluding insulin) are eligible for enrollment. (NCT02496000)
Latest
news:
- • On May 18, 2016, Oramed Pharmaceuticals announced top-line results from its Phase IIb study, designed to evaluate the safety and efficacy of its oral insulin capsule (ORMD-0801) in patients with type 2 diabetes. The study’s primary objective, a significant reduction of weighted mean night-time glucose, was successfully achieved.
- This US based double blind, 28 day, randomized study of 180 adult type 2 diabetic patients showed a statistically significant decrease in the primary endpoint, pooled night-time glucose mean percentage change of 6.47% from run-in, between placebo and active cohorts (p=0.0268). The study additionally demonstrated a good safety profile with no drug related serious adverse events. The Company plans to present and publish more comprehensive data in the future.
- • On April 5, 2016, Oramed Pharmaceuticals announced that all follow-up visits in the Company’s Phase IIb study of its oral insulin capsule, ORMD-0801, have been completed. The double-blind, randomized Phase IIb study of 180 patients with type 2 diabetes was initiated on June 30, 2015 and conducted at 33 clinical sites in the United States. The study was designed to generate ample data for both safety and efficacy endpoints. Top-line results are expected later this quarter.
- • On September 9, 2015, Oramed Pharmaceuticals announced that 98 patients have already been enrolled in the Company’s Phase IIb study of its oral insulin capsule, ORMD-0801, which represents more than 50% of the 180 patients expected to be recruited for the trial. The double-blind, randomized Phase IIb study for type 2 diabetes was initiated on June 30th and is designed to generate ample data for both efficacy and safety endpoints.
- • On June 30, 2015, Oramed Pharmaceuticals announced that the first patient has been screened in the Company’s Phase IIb trial of its oral insulin capsule, ORMD-0801. This U.S. based study will be performed under the active Investigational New Drug (IND) application on file with the FDA. The Phase IIb study for type 2 diabetes is designed to generate ample data for both safety and efficacy endpoints. The double-blind, randomized study will recruit approximately 180 patients.
- • On May 26, 2015, Oramed Pharmaceuticals announced that it has submitted the study protocol for the company’s Phase IIb trial of ORMD-0801, its oral insulin capsule, to the FDA. The submission was made under the company’s existing Investigational New Drug (IND) application. The Phase IIb study of ORMD-0801 for type 2 diabetics is designed to generate ample data for both efficacy and safety endpoints. The double-blind, randomized study will recruit approximately 180 patients and has a 28-day treatment period. The study has already received Institutional Review Board (IRB) approval and patient enrollment is expected to start in the short term.
Is
general: Yes
