Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus

NCT02496000 | Completed Phase 2 Results

• 1 other identifier: ORA-D-007
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 34

Brief Summary

Randomized, double-blind, placebo-controlled, parallel group study.

Conditions

Diabetes Type 2

Keywords

Diabetes Mellitus type 2; Metformin; oral insulin

Outcome Measures

Primary Outcomes (1)

• Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.

  The Effect of ORMD-0801 (Doses 1 \& 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.

  Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)

Secondary Outcomes (4)

• The Effect of ORMD-0801 on Mean 24-hour Glucose

  Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)

• Measure Percent Change in Continuous Glucose Monitoring Mean Fasting Glucose Between Treatment and Run-In

  Baseline (Run-in days 13-14) and Study day 1 (± 1 day) through Study day 29 (± 1 day)

• Measure the Change From Baseline to End of the Study of Morning Fasting C-Peptide (Nmol/L)

  Study day 1 (±1 day) through Study day43 (± 1 day)

• The Effect of ORMD-0801 on the Percent Change in HbA1c

  Study day 1 (± 1 day) through Study day 29 (± 1 day)

Study Arms (3)

Placebo Comparator

PLACEBO COMPARATOR

three identical capsules containing placebo

Drug: Placebo Comparator

ORMD-0801 Dose 1

EXPERIMENTAL

three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo

Drug: ORMD-0801

ORMD-0801 Dose 2 = 1.5 * Dose 1

EXPERIMENTAL

three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1

Drug: ORMD-0801

Interventions

ORMD-0801 DRUG

Oral Insulin

Also known as: Oral Insulin

ORMD-0801 Dose 1; ORMD-0801 Dose 2 = 1.5 * Dose 1

Placebo Comparator DRUG

Placebo

Also known as: Placebo

Placebo Comparator

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1c ≥7.5% if naïve to antidiabetic therapy; ≥6.5% and ≤10% if on metformin ≥1,500 mg daily; ≥6.5% and ≤9.5% if on monotherapy with an antidiabetic drug other than metformin; ≥ 6.5% and ≤9.5% if on metformin and one other antidiabetic drug; ≥ 7.0% if on metformin \<1,500 mg daily.
• At time of randomization, patients will be treated for their diabetes by diet, exercise, and metformin (≥1500 mg/day; any type and regimen). Patients will have been on a stable regimen of metformin (defined as the same metformin dose and type) for at least two weeks prior to entering the single-blind placebo run-in period.
• Other antidiabetic agents will not be used for the two weeks prior to entering the placebo run-in period.
• Patients in whom the maximum tolerated dose (MTD) of metformin is 1,000 mg will be allowed to enter the study.
• At Day -7 (Visit 3), all patients will have HbA1c ≥ 6.5% and ≤10%.
• Body Mass Index between 25 and 40 kg/m2, inclusive.
• Fasting blood glucose ≥ 126 mg/dL (8.3 mmol/L) prior to randomization at Day -7 (Visit 3). For patients in whom the Day -7 (Visit 3) fasting blood glucose is \<126 mg/dL and ≥ 115 mg/dL, and the Day -7 (Visit 3) HbA1C is ≥ 7% and ≤ 10%, a minimum of 5 daily self- monitored fasting blood glucose checks recorded in the patient diary can be averaged. If the average value is ≥ 126 mg/dL, the patient may continue in the trial.
• Females of childbearing potential must have a negative urine pregnancy test result at screening. A negative urine pregnancy test must be obtained during Visit 2 and at Visit 4 (prior to randomization).
• Males and females of childbearing potential must use two methods of contraception (double barrier method), one of which must be an acceptable barrier method from the time of screening to the last study visit (Day 43).
• Patient has \>80% compliance with placebo during run in prior to randomization.
• Patient has ≥ 80% of the glucose readings on at least two 24 hour periods (6AM - 6AM) during the seven day CGM period.
• Patient has performed ≥ 10/14 of the self monitored glucose level measurements during placebo run-in, prior to randomization.

You may not qualify if:

• \- Patients who meet any of the following criteria are not eligible for this study.
• Presence of any clinically significant endocrine disease according to the Investigator (euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least six weeks prior to Screening Visit).
• Clinical diagnosis of Type 1 diabetes.
• Fasting blood glucose \>260 mg/dL at the end of Day -7/Visit 3. For patient in whom the Day 07 (Visit 3) fasting blood glucose is \> 260 mg/dL and \< 300 mg/dL, and the Day -7 (Visit 3) HbA1C is ≥ 7% and ≤ 10%, a minimum of 5 self-monitored fasting blood glucose checks recorded in the patient diary can be averaged. If the average value is ≤ 260 mg/dL, the patient may continue in the trial.
• Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer.
• Laboratory abnormalities at screening including:
• C-peptide \< 1.0 ng/mL.
• Positive pregnancy test in females of childbearing potential (at screening and start of run-in period).
• Abnormal serum thyrotropin (TSH) levels \>1.5 times the upper limit of normal.
• Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
• Positive test for HIV.
• Serum Cr \>1.4mg/dl in males, \>1.3mg/dl in females.
• Any relevant abnormality interfering with the efficacy or the safety assessments during study drug administration.
• Use of the following medications:
• History of use of insulin for greater than one week in the last six months and any use of insulin in the last six weeks prior to randomization.

Sponsors & Collaborators

• Oramed, Ltd.: lead
• Integrium: collaborator

Study Sites (34)

Steingard Medical Group

Phoenix, Arizona, 85015, United States

Location

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, 72204, United States

Location

Dream Team Clinical Research

Anaheim, California, 92801, United States

Location

ACTCA, Inc.

Los Angeles, California, 90017, United States

Location

ACTCA

Los Angeles, California, 90036, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Mills-Peninsula Health Services

San Mateo, California, 94401, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Creekside Endocrine Associates, PC

Denver, Colorado, 80209, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

Research in Miami Inc.

Hialeah, Florida, 33013, United States

Location

Research in Miami, Inc.

Hialeah, Florida, 33013, United States

Location

Phoenix Medical Research LLC

Miami, Florida, 33165, United States

Location

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, Florida, 32174, United States

Location

Clinical Research of West Florida, Inc.

Tampa, Florida, 33603, United States

Location

Meridien Research

Tampa, Florida, 33634, United States

Location

Metabolic Research Institute, Inc

West Palm Beach, Florida, 33401, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Maine Research Associates

Auburn, Maine, 04210, United States

Location

Apex Medical Research, MI, Inc

Flint, Michigan, 48504, United States

Location

Impact Clinical Trials

Las Vegas, Nevada, 89106, United States

Location

New York Clinical Trials

New York, New York, 10018, United States

Location

Lynn Institute of Norman

Norman, Oklahoma, 73069, United States

Location

Upstate Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

Padre Coast Clinical Research

Corpus Christi, Texas, 78404, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Southwest Clinic

San Antonio, Texas, 78221, United States

Location

Panacea Clinical Research

San Antonio, Texas, 78228, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ORMD-0801; Insulin

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

Results Point of Contact

• Title: Joel M. Neutel, M. D.
• Organization: Orange County Research Center

jmneutel@aol.com

714-541-5591

Study Officials

• Joel M Neutel, M.D.

  Orange County Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 14, 2015
• Study Start: July 27, 2015
• Primary Completion: June 27, 2016
• Study Completion: September 13, 2016
• Last Updated: November 13, 2019
• Results First Posted: February 17, 2017

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)