ORMD-0801 for Diabetes

Overseen By Meir S. Silver, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Oramed, Ltd.

Must be taking: Glucose-lowering agents

Must not be taking: Injected insulin, Steroids

Disqualifiers: Type 1 diabetes, Severe hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 26 weeks

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current glucose-lowering medications if you are on a stable dose of up to three specific types. However, if you are using injected insulin or certain other medications, you may need to stop those before joining the trial.

What data supports the effectiveness of the drug ORMD-0801 for diabetes?

The research highlights that combining different oral antidiabetic drugs can improve blood sugar control in people with type 2 diabetes, suggesting that ORMD-0801, as an oral treatment, might also help in managing diabetes effectively. ^{1 2 3 4 5}

What makes the drug ORMD-0801 unique for treating type 2 diabetes?

ORMD-0801 is unique because it is an oral form of insulin, which is different from the traditional insulin injections used for type 2 diabetes. This oral administration could make it easier and more convenient for patients to manage their condition. ^{6 7 8 9 10}

What is the purpose of this trial?

ORA-013-3 is a randomized, controlled study to test the efficacy and safety of an oral capsule of ORMD-0801 at several doses in patients with Type 2 Diabetes Mellitus (T2DM) who have not responded well to other glucose-lowering medications. A total of three hundred subjects will be enrolled in this study and will be required to complete this thirty-four-week clinical trial.

Research Team

Miriam Kidron, Ph.D.

Principal Investigator

Oramed, Ltd.

Eligibility Criteria

This trial is for people with Type 2 Diabetes Mellitus who haven't had much success with other glucose-lowering meds. They'll be part of a study lasting about 34 weeks.

Inclusion Criteria

I have been on a stable dose of a diabetes medication for at least 3 months.

Body mass index (BMI) of ≤ 28 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening

My kidney function is good, with an eGFR of 30 ml/min or higher.

Exclusion Criteria

A history of > 2 episodes of severe hypoglycemia within 6 months prior to Screening

A history of hypoglycemic unawareness

My kidney function is low, with an eGFR under 30 mL/min.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

3 visits (in-person)

Treatment

Participants receive double-blind treatment with ORMD-0801 or placebo for 26 weeks

26 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• ORMD-0801

Trial Overview The study tests ORMD-0801, an oral capsule for diabetes, at two different doses (8 mg and 16 mg) compared to a placebo to see how effective and safe it is.

Participant Groups

Group I: ORMD-0801 8 mg once-daily at night - QD Active Control 2 Interventions

Double-Dummy; the subject receives both experimental drug and placebo. 1 x 8 mg capsule between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 2 placebo capsules (1 in the morning and 1 at night).

Group II: ORMD-0801 8 mg twice daily - BID Active Control 2 Interventions

Double-Dummy; the subject receives both experimental drug and placebo. 1 x 8 mg capsule each morning approximately 45 minutes (±15 minutes) prior to breakfast and 1 x 8 mg capsule each night prior to bedtime (between 8 PM to 12 Midnight and no sooner than 1 hour after dinner) and 1 placebo capsule at night.

Group III: ORMD-0801 16 mg once-daily at night - QD Active Control 2 Interventions

Double-Dummy; the subject receives both experimental drug and placebo. 2 x 8 mg capsules between 8 PM to 12 Midnight and no sooner than 1 hour after dinner and 1 placebo capsule in the morning.

Group IV: Placebo Placebo Group 1 Intervention

The subject receives 3 placebo capsules.

Who Is Running the Clinical Trial?

Oramed, Ltd.

Lead Sponsor

Trials

15

Recruited

2,800+

InClin, Inc.

Collaborator

Trials

3

Recruited

620+

Findings from Research

In a study of 69 patients with poorly controlled type 2 diabetes, improved control was significantly associated with better understanding of diabetes, adherence to meal plans, and regular glucose monitoring, highlighting the importance of self-care behaviors.

Interestingly, increased use of medications was inversely related to achieving better control, suggesting that patient education and lifestyle changes may be more effective than simply intensifying medication regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that influence improvement for patients with poorly controlled type 2 diabetes. Hartz, A., Kent, S., James, P., et al.[2022]

In a study of 4627 patients with type 2 diabetes, those with moderate or poor glycemic control were significantly more likely to change their oral antidiabetic treatment patterns, such as switching or augmenting therapy, compared to those with good control.

Men generally had worse glycemic control at the start of treatment, and younger patients were more likely to modify their therapy, indicating that initial control levels and demographics play a crucial role in treatment adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycemic control and the first use of oral antidiabetic agents among patients with type 2 diabetes mellitus. Mitchell, BD., Eby, EL., Lage, MJ.[2013]

In a study of type 2 diabetes patients with poor glycemic control despite insulin therapy, adding tofogliflozin significantly improved HbA1c levels, reducing them by -1.0% compared to a slight decrease in the insulin-only group.

Tofogliflozin not only helped lower HbA1c but also reduced the total daily insulin dose and weight in patients, indicating it may be a safe and effective add-on therapy for better diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Combined Tofogliflozin and Glargine, Tofogliflozin Added to Insulin, and Insulin Dose-Increase Therapy in Uncontrolled Type 2 Diabetes. Suzuki, K., Mitsuma, Y., Sato, T., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of type 2 diabetes mellitus with orally administered agents: advances in combination therapy. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Factors that influence improvement for patients with poorly controlled type 2 diabetes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effects of age, gender, and body mass index on efficacy and hypoglycaemia outcomes across treat-to-target trials with insulin glargine 100 U/mL added to oral antidiabetes agents in type 2 diabetes. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Glycemic control and the first use of oral antidiabetic agents among patients with type 2 diabetes mellitus. [2013]

5. Canada pubmed.ncbi.nlm.nih.gov

Comparison of Combined Tofogliflozin and Glargine, Tofogliflozin Added to Insulin, and Insulin Dose-Increase Therapy in Uncontrolled Type 2 Diabetes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Oral insulin (ORMD-0801) in type 2 diabetes mellitus: A dose-finding 12-week randomized placebo-controlled study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of 28-day treatment with oral insulin (ORMD-0801) in patients with type 2 diabetes: A randomized, placebo-controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Different modes of action of the imidazoline compound RX871024 in pancreatic beta-cells. Blocking of K+ channels, mobilization of Ca2+ from endoplasmic reticulum, and interaction with exocytotic machinery. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Diazoxide treatment at onset preserves residual insulin secretion in adults with autoimmune diabetes. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Insulinotropic activity of the imidazoline derivative RX871024 in the diabetic GK rat. [2018]