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

NCT04754334 | Terminated Phase 3 FDA Drug

• 1 other identifier: ORA-D-013-2
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

This double-masked placebo-controlled study will include approximately 450 subjects with inadequately controlled T2DM on diet control alone or on diet control and metformin monotherapy. Subjects will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a Double-Blind 26-week Treatment Extension Period.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• Mean change in A1C

  mean change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for the active and placebo groups. Randomization will occur at Visit 1 (Week 0),

  Baseline and Week 26

Secondary Outcomes (1)

• The mean change in fasting plasma glucose

  baseline and week 26

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo dosed QD

Other: Placebo

ORMD-0801

EXPERIMENTAL

ORMD-0801 8 mg QD

Drug: ORMD-0801

Interventions

ORMD-0801 DRUG

Oral Insulin

Also known as: Oral Insulin

ORMD-0801

Placebo OTHER

Fish Oil

Also known as: Fish Oil

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Established diagnosis of T2DM for at least 6 months prior to Screening AND an A1C ≥ 7.5% but ≤ 11.0% at Screening.
• \. Subjects should be on:
• a. Diet and exercise therapy with no oral or injectable glucose lowering therapy for a period of at least 3 months prior to screening; OR
• b. Diet and exercise therapy with a stable dose of metformin only (≥1500 mg or maximal tolerated dose) for a period of at least 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 - GFR ≥ 30 ml/min/1.73 m2.
• \. Females of childbearing potential must:
• a. have a negative serum pregnancy test result at Screening.
• b. 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.
• c. 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.
• d. 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.
• e. 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.
• f. 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

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).
• \. Concomitant treatment involving insulin, and any other inhaled, oral or injectable antihyperglycemic agents including alpha glucosidase inhibitor, meglitinides, sulfonylurea, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione or GLP-1 agonists, and pramlintide within 2 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: GFR \< 30 mL/min/1.73 m2.
• \. 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:
• a. C-peptide \< 0.4 ng/mL.
• b. 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

• Oramed, Ltd.: lead
• Integrium: collaborator

Study Sites (1)

Research Institute of South Florida, Inc. (PHARMASEEK)

Coral Gables, Florida, 33124, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ORMD-0801; Insulin; Fish Oils

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Oils; Lipids

Study Officials

• Miriam Kidron, PhD

  Oramed, Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Approximately 450 US- and Europe-based adult male and female subjects with T2DM will be randomized in a 1:1 ratio to receive either ORMD-0801 8 mg QD (one 8 mg capsule, dosed at night), or placebo dosed QD (dosed at night). It is anticipated that 225 subjects will be randomized to each arm of the study to complete approximately 200 subjects in each arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 450 US- and Europe-based adult male and female subjects with T2DM will be randomized in a 1:1 ratio to receive either ORMD-0801 8 mg QD (one 8 mg capsule, dosed at night), or placebo dosed QD (dosed at night). It is anticipated that 225 subjects will be randomized to each arm of the study to complete approximately 200 subjects in each arm.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 15, 2021
• Study Start: March 16, 2021
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)