Clinical Trials

Date: 2014-10-22

Type of information: Results

phase: 2a

Announcement: results

Company: Oramed Pharmaceuticals (Israel)

Product: oral insulin ORMD-0801

Action mechanism:

Disease: type 1 diabetes mellitus

Therapeutic area: Metabolic diseases

Country: Israel, USA

Trial details: This Phase 2a clinical trial is a prospective, randomized, double-blind, placebo-controlled study designed to enroll up to 24 patients with type 1 diabetes in-clinic for 10 days.  Patients will be randomized in a 2:1 ratio to receive either ORMD-0801 or placebo. The primary endpoint of the trial is to evaluate the change from baseline in exogenous insulin requirements (basal, bolus, and total) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. Secondary endpoints include evaluating the change from baseline in mean nighttime, daytime, and fasting glucose levels in type 1 diabetes patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo.  (NCT02094534)

Latest news:

• • On October 22, 2014, Oramed Pharmaceuticals , a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, reported positive top-line clinical results from its Phase IIa clinical trial of ORMD-0801, the company's proprietary oral insulin capsules, to treat type 1 diabetes. The trial was conducted in the United States.
• The prospective, randomized, double-blind, placebo controlled study evaluated the safety and impact of ORMD-0801 given before meals on the exogenous insulin requirements in 25 established type 1 diabetic patients. The primary endpoint of the study was the change from baseline in exogenous insulin requirements (basal, bolus and total) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. The secondary endpoint of the study was the change from baseline in mean nighttime, daytime and fasting glucose levels (by continuous glucose monitoring) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. The results showed that ORMD-0801 oral insulin given before meals appeared to be safe and well-tolerated for the dosing regimen in this study. Although the study was not powered to show statistical significance, there were internally consistent trends observed. Consistent with the timing of administration, the data showed a decrease in rapid acting insulin, a decrease in post-prandial glucose, a decrease in daytime glucose by continual glucose monitoring and an increase in post-prandial hypoglycemia in the active group. "We continue to build our body of human clinical data in support of the use of ORMD-0801 to treat both type 1 and type 2 diabetes. With the data gathered so far, we look forward to initiating our Phase IIb study of ORMD-0801 in type 2 diabetes patients", commented Miriam Kidron, Ph.D., Chief Scientific Officer of Oramed.
• • On August 7, 2014, Oramed Pharmaceuticals reported that the last patient has completed treatment in its Phase IIa clinical trial of ORMD-0801, the Company's proprietary oral insulin capsule, to treat type 1 diabetes, and top-line data is expected to be reported in the fourth quarter of 2014. The trial was conducted in the United States under a Food and Drug Administration Investigational New Drug protocol. The prospective, randomized, double-blind, placebo controlled study in patients with established type 1 diabetes is evaluating the safety and impact of ORMD-0801 on the exogenous insulin requirements in 24 type 1 diabetics patients.
• • On March 27, 2014, Oramed Pharmaceuticals has announced that the first patient has been enrolled in its U.S. Phase 2a trial for its orally ingestible insulin capsule, ORMD-0801, in the treatment of type 1 diabetes.
• • On February 10, 2014, Oramed Pharmaceuticals has announced that it has submitted a protocol to the FDA to initiate a Phase 2a trial of its orally ingestible insulin capsule, ORMD 0801, for type 1 diabetes. The protocol was submitted under Oramed's existing IND for ORMD-0801 to include both type 1 and type 2 diabetes indications. The double-blind, randomized, placebo controlled, seven-day study design will be carried out at an inpatient setting on twenty-four type 1 diabetic patients. This US- based study is expected to start later this quarter.
• • On December 20, 2013, Oramed Pharmaceuticals  has announced successful results in a clinical trial testing the pharmacokinetic dose response of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients. Patients were treated with a different dose of oral insulin at each study visit; blood glucose and insulin levels were then monitored for the ensuing five hours.  Patient responses positively correlated with administered doses, as did the duration of the effect. "Based on these and the notable results from our previous oral insulin trials in type 1 diabetes, we continue to move forward with this indication in parallel to our advanced clinical studies in type 2 diabetes," commented CEO Nadav Kidron.
• • On August 21, 2013, Oramed Pharmaceuticals has announced that it has initiated patient recruitment for a new clinical trial of its orally ingestible insulin capsule, ORMD-0801 for patients with type 1 diabetes mellitus (T1DM) in Israel. Prior clinical studies have shown that ORMD-0801 administered to T1DM patients just prior to a meal effectively kept their blood sugar levels stable. The results of one such trial were published earlier this year in PLOS ONE (See below).
• • On May 1, 2013, Oramed Pharmaceuticals, a developer of oral delivery systems of drugs currently administered by injection, has announced that its article titled, "Glucose-reducing effect of the ORMD-0801 oral insulin preparation in patients with uncontrolled Type 1 diabetes: a pilot study," has been published in PLOS ONE, an international, peer-reviewed, open-access journal which covers primary scientific and medical research. The article details the results of a clinical study, in which ORMD-0801 was administered to patients with unstable Type 1 diabetes, in conjunction with their regular anti-diabetes treatment regimens.  These patients typically suffer from unpredictable and frequent swings in their blood sugar levels, which often demand hospitalization and severely disrupt their quality of life. The addition of ORMD-0801 was well tolerated and significantly stabilized blood sugar levels in this patient group. A significant drop in the frequency of above-normal blood sugar readings was observed, as well as a decrease in overall blood sugar levels throughout the day.
• • On April 29, 2013, Oramed Pharmaceuticals has announced that its abstract, entitled "Oral insulin capsules toward management of Type 1 diabetes mellitus," will be presented at the Global Technology Community Diabetes Summit 2013. The work summarizes the results of Oramed's key clinical studies assessing the safety and efficacy of its oral insulin formulation (ORMD-0801) in patients with Type 1 diabetes (T1DM) and in a subpopulation of T1DM patients who experience frequent and unpredictable swings in their blood sugar levels.  ORMD-0801 was safe and well tolerated and effectively kept blood sugar levels in check, when administered before meals.  In addition, the blood sugar readings of unstable T1DM patients more frequently fell within the normal range, when compared to those of the pretreatment monitoring sessions. The presented results demonstrate that Oramed\'s technology effectively delivers insulin without compromising its bioactivity, and serve as an impetus to realize the therapeutic potential of ORMD-0801 in regulating T1DM. The poster is available on Oramed's website (http://www.oramed.com/ufiles/GTC%20Diabetes%20Summit%202013.pdf)

Is general: Yes