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

NCT04606576 | Terminated Phase 3 FDA Drug

• 1 other identifier: ORA-D-013-1
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized, double-blind, double-dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a 26-week Double-Blind Treatment Extension Period.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in A1C

  The mean change from baseline (Visit 1) in A1C at 26 weeks (Visit 6) for the active and placebo groups.

  Baseline and 26 Weeks

Secondary Outcomes (1)

• Mean change in fasting glucose

  Baseline and 26 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Fish Oil

Other: Placebo

ORMD-0801 QD

EXPERIMENTAL

8 mg ORMD-0801 administered QD at night

Drug: ORMD-0801 QD

ORMD-0801 BID

EXPERIMENTAL

8 mg ORMD-0801 administered at night and in the morning 45 minutes before breakfast.

Drug: ORMD-0801 BD

Interventions

Placebo OTHER

Fish Oil

Also known as: Fish Oil

Placebo

ORMD-0801 QD DRUG

Oral Insulin once per day

Also known as: Oral Insulin

ORMD-0801 QD

ORMD-0801 BD DRUG

Oral Insulin, twice per day

Also known as: Oral Insulin

ORMD-0801 BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• 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 one and up to three of the following oral glucose-lowering agents: Metformin, DPP-4 inhibitor, SGLT-2 inhibitor, thiazolidinedione, or sulfonylurea 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 - 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
• 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, insulin secretagogues (other than sulfonylureas), or GLP-1 receptor agonists 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: 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 the 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)

Orange County Research Center (OCRC) 14351 Myford Rd., Suite B, Tustin, CA 92780

Tustin, California, 92780, United States

Location

Related Publications (4)

• American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S14-S31. doi: 10.2337/dc20-S002.

  PMID: 31862745 BACKGROUND

• Cleary PA, Orchard TJ, Genuth S, Wong ND, Detrano R, Backlund JY, Zinman B, Jacobson A, Sun W, Lachin JM, Nathan DM; DCCT/EDIC Research Group. The effect of intensive glycemic treatment on coronary artery calcification in type 1 diabetic participants of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study. Diabetes. 2006 Dec;55(12):3556-65. doi: 10.2337/db06-0653.

  PMID: 17130504 BACKGROUND

• Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

  PMID: 8366922 BACKGROUND

• Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R, Zinman B. Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006 Aug;29(8):1963-72. doi: 10.2337/dc06-9912. No abstract available.

  PMID: 16873813 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Fish Oils; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Miriam Kidron, PhD

  Oramed, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this randomized, double-blind, double dummy, placebo-controlled study, approximately 675 eligible subjects with type 2 diabetes and inadequate control on at least one and up to 3 oral glucose-lowering agents will undergo an initial 21-day Screening Period, followed by a 26-week Double-Blind Treatment Period and a 26-week Double-Blind Treatment Extension Period.

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 28, 2020
• Study Start: December 15, 2020
• 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)