Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus

NCT04817215 | Unknown Phase 3 DMC

• 1 other identifier: ORMD-0801-KHUH
• Study Type: interventional
• Target: 608
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents. To assess the safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects on on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline (Visit 1) in A1C at 26 weeks

  • Means and mean changes from baseline over time for A1C and FPG during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period.

  6 months with follow-up extension for additional six months

Secondary Outcomes (1)

• Safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects

  6 months with follow-up extension for additional six months

Other Outcomes (6)

• Change from baseline (Visit 1) in CGM-parameters (using a FreeStyle Libre)

  6 months with follow-up extension for additional six months

• Proportion of subjects achieving A1C < 8%

  6 months with follow-up extension for additional six months

• Proportion of subjects achieving A1C < 7%

  6 months with follow-up extension for additional six months

Study Arms (3)

Patients who are Drug naïve or diet controlled

EXPERIMENTAL

Drug: ORMD-0801

Patients on Metformin only

EXPERIMENTAL

Drug: ORMD-0801

Patients on two or three oral glucose-lowering agents

EXPERIMENTAL

Drug: ORMD-0801

Interventions

ORMD-0801 DRUG

Randomized to receive ORMD-0801 8 mg QD or 8 mg BID or matching placebo

Patients on Metformin only; Patients on two or three oral glucose-lowering agents; Patients who are Drug naïve or diet controlled

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged 18 - 75 years
• Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.5% but ≤ 11.0% at Screening
• On a stable dose of at least two and up to three of the following oral glucose-lowering agents: Metformin, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione, insulin secretagogue, or oral GLP-1 receptor agonists for a period of 3 months prior to Screening
• Body mass index (BMI) of 25-40 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening
• Renal function - eGFR ≥ 30 ml/min.
• Females of childbearing potential must:
• have a negative serum pregnancy test result at Screening.
• agree to avoid becoming pregnant while receiving IP for at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP.
• agree to use an acceptable method of contraception at least 30 days prior to IP administration, during the entire study, and for 30 days following their last dose of IP. Acceptable methods of contraception are hormonal contraception (contraceptive pill or injection) PLUS an additional barrier method of contraception such as a diaphragm, condom, sponge, or spermicide
• In the absence of hormonal contraception, double-barrier methods must be used which include a combination of any two of the following: diaphragm, condom, copper intrauterine device, sponge, or spermicide, and must be used for at least 30 days prior to administration of IP, during the entire study, and for 30 days following their last dose of IP.
• Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ERCs/IRBs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception
• Females who are not of childbearing potential are defined as:
• i. Postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); OR ii. Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR iii. Have a congenital or acquired condition that prevents childbearing.

You may not qualify if:

• Subjects with:
• Type 1 diabetes
• A history of diabetes mellitus with ketoacidosis or is assessed by the Investigator as possibly having type 1 diabetes mellitus confirmed by a C-peptide \< 0.4 ng/mL (0.13 nmol/L) at Screening
• Diabetes attributable to other secondary causes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
• Treatment involving glucosidase inhibitor, injected insulin, or injected GLP-1 receptor agonists (oral GLP-1 receptor antagonists are permitted), and pramlintide within 3 months prior to Visit 1.
• A history of \>2 episodes of severe hypoglycemia within 6 months prior to Screening.
• A history of hypoglycemic unawareness.
• A history of unstable angina or myocardial infarction within 6 months prior to Screening, New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure (CHF), valvular heart disease, ventricular cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, coronary angioplasty, stroke or transient ischemic attack (TIA) within 6 months prior to Screening.
• A history of uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg. A single repeat measurement will be permitted
• Renal dysfunction: eGFR \< 30 mL/min
• A history of or active proliferative retinopathy requiring treatment
• Psychiatric disorders that, per Investigator judgment, may have impact on the safety of the subject or interfere with subject's participation or compliance in the study
• Laboratory abnormalities at Screening including:
• C-peptide \< 0.4 ng/mL
• Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or \>1.5X the upper limit of normal; a single repeat test is allowable

Sponsors & Collaborators

• King Hamad University Hospital, Bahrain: lead
• Royal College of Surgeons in Ireland - Medical University of Bahrain: collaborator
• Oramed, Ltd.: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ORMD-0801

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dr. Dalal Alromaihi

  King Hamad University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Dalal Alromaihi

CONTACT

97339907906; dalal.alromaihi@khuh.org.bh

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 26, 2021
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 26, 2021

Record last verified: 2021-03