A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics

NCT02094534 | Completed Phase 2 Results

• 1 other identifier: ORA-D-010
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study. Eligible patients will be screened and those who fulfill all inclusion/exclusion criteria will be admitted to the inpatient unit no fewer than 2 days and no more than 7 days after Screening. Patients will report to the inpatient unit at 6 a.m. and outfitted with a continuous glucose monitoring (CGM) device. Patients will be given standardized meals and snacks for the duration of their inpatient visit.

Conditions

Diabetes Mellitus Type 1

Keywords

Diabetes type 1; Oral Insulin; Safety; Tolerability; Phase 2a; Randomized; Blinded; Parallel

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements

  Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.

  Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)

Secondary Outcomes (1)

• Mean Nighttime, Daytime, and Fasting Glucose Levels

  last two days (day 6 and day 7, averaged)

Study Arms (2)

ORMD-0801 Capsules

EXPERIMENTAL

API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules, ORMD-0801

Biological: ORMD-0801 Capsules

Placebo

PLACEBO COMPARATOR

Fish oil in capsules, identical in appearance to ORMD-0801

Other: Placebo

Interventions

ORMD-0801 Capsules BIOLOGICAL

API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.

Also known as: Oral Insulin

ORMD-0801 Capsules

Placebo OTHER

Fish oil capsules, identical in appearance to the experimental intervention.

Also known as: Fish Oil

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and Females age 18 to 55 years old, inclusive.
• Patients must be willing and able to sign informed consent.
• Documented history of Type 1 Diabetes for at least 6 months
• Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urinary screening test following admission to the inpatient unit

You may not qualify if:

• 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)
• Fasting plasma glucose \>260 mg/dL at the end of run-in
• Evidence of unawareness of hypoglycemia with a documented plasma glucose ≤50 mg/dL in the absence of symptoms of hypoglycemia
• Presence of any clinically significant condition that might interfere with the evaluation of study medication (i.e., significant renal, hepatic, gastrointestinal (GI), cardiovascular (CV), immune disease).
• 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:
• Positive pregnancy test in females of childbearing potential (at screening and Day -3 of Visit 2)
• Abnormal serum thyrotropin (TSH) levels \>1.5X upper limit of normal (ULN)
• Positive test for hepatitis B surface antigen and/or hepatitis C antibody
• Positive test for HIV
• Any relevant abnormality interfering with the efficacy or the safety assessments during study drug administration
• Use of the following medications:
• o History of use of aprotinin at any time prior to the screening visit (e.g., Trasylol, any type or dose)
• Administration of thiazolidinedione \[e.g., (Actos (pioglitazone) and Avandia (rosiglitazone)\] treatment within 3 months prior to randomization.
• Administration of thyroid preparations or thyroxine (except in patients on stable replacement therapy) within 6 weeks prior to screening visit

Sponsors & Collaborators

• Oramed, Ltd.: lead
• Integrium: collaborator

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

ORMD-0801; Insulin; Fish Oils

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

jmneutel@aol.com

714-550-9990

Study Officials

• Miriam Kidron, Ph.D.

  Oramed, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: March 20, 2014
• First Posted: March 24, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 6, 2017
• Results First Posted: July 6, 2017

Record last verified: 2017-06

Locations

US (1)