Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM)

NCT01889667 | Completed Phase 2 Results DMC

• 2 other identifiers: ORA-D-009ORMD-0801
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety and pharmacodynamics of an oral formulation of insulin in subjects with Type 2 Diabetes.

Conditions

Diabetes Mellitus Type 2

Keywords

Oral Insulin; Diabetes Mellitus Type 2; Safety; Pharmacodynamics; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Evaluate the Safety and Tolerability of ORMD-0801.

  Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug

  Eight (8) days

Secondary Outcomes (4)

• The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)

  Seven (7) days, and last two days (Day 6 and day 7)

• The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM)

  Seven (7) days, and last two days (Day 6 and day 7)

• The Effect of ORMD-0801 on Morning Fasting Serum Insulin

  Screening, Day 2. Day 9

• The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo

  Screening, Day 2, Day 9

Study Arms (3)

ORMD-0801 Dose # 1

EXPERIMENTAL

Oral Insulin Formulation

Drug: ORMD-0801 Dose # 1

ORMD-0801 Dose # 2

EXPERIMENTAL

Oral Insulin Formulation

Drug: ORMD-0801 Dose # 2

Placebo

PLACEBO COMPARATOR

Oil Capsules

Drug: Placebo

Interventions

ORMD-0801 Dose # 1 DRUG

Oral Insulin Formulation

Also known as: Oral Insulin

ORMD-0801 Dose # 1

ORMD-0801 Dose # 2 DRUG

Oral Insulin Formulation

Also known as: Oral Insulin

ORMD-0801 Dose # 2

Placebo DRUG

Oil Capsules

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, age 20 to 70 years, inclusive with T2DM;
• At randomization, patients are treated for diabetes by diet and exercise, or by diet, exercise and metformin (\>1000 mg/day; any type and regimen). Patients on a stable regimen of metformin (defined as the same metformin dose and type) for at least 6 weeks prior to entering the placebo run-in period. Other anti-diabetic agents not in use for the 6 weeks prior to entering the placebo run-in period;
• kg/m2 ≤ BMI ≤ 40 kg/m2
• % ≤ HbA1c ≤ 10.5%, prior to randomization)
• Fasting plasma glucose ≥ 126 mg/dL (8.3 mmo1/L) prior to randomization;
• No tobacco or nicotine use within 10 wks prior to screening;
• Females of child-bearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test at Visit 3. Females of non-childbearing potential are defined as postmenopausal who:
• had more than 24 months since last menstrual cycle with menopausal levels of FSH;
• age \> 55 years old; or
• are surgically menopausal.

You may not qualify if:

• Presence of any clinically significant endocrine disease according to the PI;
• Clinical diagnosis of T1DM;
• Fasting plasma glucose \> 260 mg/dL at the end of washout/stabilization/run-in periods;
• Evidence of unawareness of hypoglycemia, 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;
• Presence or history of cancer within the past 5 yrs. with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer;
• Laboratory abnormalities at screening:
• C-peptide \< 1.0 ng/mL;
• Positive pregnancy test in females of childbearing potential (at screening and start of run-in period);
• Abnormal TSH levels \> 1.5 x the upper limit of normal;
• 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
• History of use of insulin for no more than 1 wk in the last 6 mos and none in the last 6 wks prior to randomization;

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 2

Interventions

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: Chief Scientific Officer
• Organization: Oramed

aviva@oramed.com

+972-2-566-0001

Study Officials

• Joel M Neutel, M. D.

  Orange County Research Center

  STUDY DIRECTOR

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: June 19, 2013
• First Posted: June 28, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 16, 2015
• Results First Posted: October 24, 2014

Record last verified: 2014-10

Locations

US (1)