Diabetes Mellitus Type 2Phase 2NCT01889667

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

A Phase 2 study testing ORMD-0801 Dose # 1 and ORMD-0801 Dose # 2 in people with Diabetes Mellitus Type 2, run by Oramed, Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: ORMD-0801 Dose # 1 and ORMD-0801 Dose # 2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Nov 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
25 kg/m2 ≤ BMI ≤ 40 kg/m2
6.5% ≤ 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;

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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.

Who cannot join

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;

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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;
History of use of aprotinin at any time prior to the screening visit;
Administration of anti-diabetic drugs other than metformin within 6 wks prior to run-in period;
Administration of thiazolidinedione 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;
Administration of systemic long-acting corticosteroids within two months or prolonged use of other systemic corticosteroids or inhaled corticosteroids within 30 days prior to screening visit;
Use of medications known to modify glucose metabolism or to decrease the ability to recover from hypoglycemia such as oral, parenteral, and inhaled steroids, beta blockers (with the exception of beta blocker ophthalmic solutions for glaucoma or ocular hypertension), and immunosuppressive or immunomodulating agents.
History of severe or multiple allergies;
History of tobacco or nicotine use within 10 wks prior to screening
Patient is on a weight loss program and is not in the maintenance phase, or patient that started weight loss medication within 8 wks prior to screening;
Pregnancy or breast-feeding;
Patient has a screening visit systolic blood pressure of ≥165 mm Hg or diastolic blood pressure of ≥100 mm Hg. Patients will be allowed to take a BP rescue medication as long as it does not affect glucose metabolism (e.g., diuretics) or sensation of hypoglycemia (e.g., beta-blockers);
Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence;
Elevated liver enzymes ALT, AST, alkaline phosphatase) > 2 x the upper limit of normal at screening;
Very high triglyceride level (>600 mg/dL) at screening;
ECG abnormality at screening or CV. Clinically significant CV will include
history of stroke, transient ischemic attack, or MCI within 6 months prior to screening;
history of or currently have NYHA Class II-IV heart failure prior to screening; or
uncontrolled hypertension defined as BP ≥180 mmHg (systolic) or ≥110 mmHG (diastolic) at screening or at Visit 2;
One or more contraindications to metformin;
History of gastrointestinal disorders with the potential to interfere with drug absorption;
At the Principal Investigator's discretion, any condition or other factor that is deemed unsuitable for patient enrollment into the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Orange County Research Center
Tustin, California, 92780

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, PK and PD of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With T2DM Who Are Inadequately Controlled With Diet and Exercise or Diet, Exercise and Metformin

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

Read the detailed description

This is a single-center, Phase II(a), randomized, double-blind, placebo-controlled, parallel group, inpatient study preceded by a 5-day single-blind outpatient placebo run-in period.

Conditions: Diabetes Mellitus Type 2
Being tested: ORMD-0801 Dose # 1, ORMD-0801 Dose # 2, Placebo
Keywords: Oral Insulin, Diabetes Mellitus Type 2, Safety, Pharmacodynamics, Pharmacokinetics
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ORMD-0801 Dose # 1Drug
Also called Oral Insulin
Oral Insulin Formulation
ORMD-0801 Dose # 2Drug
Also called Oral Insulin
Oral Insulin Formulation
PlaceboDrug
Oil Capsules

Study groups in NCT01889667
Study group	Role	What they receive
ORMD-0801 Dose # 1	Experimental	Oral Insulin Formulation Receives: Drug: ORMD-0801 Dose # 1
ORMD-0801 Dose # 2	Experimental	Oral Insulin Formulation Receives: Drug: ORMD-0801 Dose # 2
Placebo	Placebo comparator	Oil Capsules Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the Safety and Tolerability of ORMD-0801.
Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug
Measured: Eight (8) days

Secondary outcomes (4)

The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)
Difference between concentration of Nightime Glucose of patients on Placebo and concentration of Nightime Glucose of patients on ORMD-0801
Measured: 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)
Difference between concentration of Mean Daytime Glucose of patients on Placebo and concentration of Mean Daytime Glucose of patients on ORMD-0801
Measured: Seven (7) days, and last two days (Day 6 and day 7)
The Effect of ORMD-0801 on Morning Fasting Serum Insulin
Difference between concentration of Morning fasting serum insulin of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801
Measured: Screening, Day 2. Day 9
The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo
Difference between concentration of Morning fasting C-peptide of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801
Measured: Screening, Day 2, Day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Nov 2013

First posted28 Jun 2013 (estimated)
Study startJun 2013
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01889667
Sponsor's protocol ID: ORA-D-009
Other IDs: ORMD-0801
Status last verified: Oct 2014
First submitted: 19 Jun 2013
Last updated: 16 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, PK and PD of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With T2DM Who Are Inadequately Controlled With Diet and Exercise or Diet, Exercise and Metformin
ClinicalTrials.gov ID: NCT01889667
Acronym / sponsor ID: ORA-D-009
Conditions: Diabetes Mellitus Type 2
Keywords: Oral Insulin, Diabetes Mellitus Type 2, Safety, Pharmacodynamics, Pharmacokinetics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Oramed, Ltd.Industry (pharma, biotech, devices)
Collaborators: Integrium
Study start: Jun 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 28 Jun 2013 (estimated)
Results: Posted 24 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

This is a single-center, Phase II(a), randomized, double-blind, placebo-controlled, parallel group, inpatient study preceded by a 5-day single-blind outpatient placebo run-in period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ORMD-0801 Dose # 1	Experimental	Drug: ORMD-0801 Dose # 1Oral Insulin Formulation
ORMD-0801 Dose # 2	Experimental	Drug: ORMD-0801 Dose # 2Oral Insulin Formulation
Placebo	Placebo comparator	Drug: PlaceboOil Capsules

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;
25 kg/m2 ≤ BMI ≤ 40 kg/m2
6.5% ≤ HbA1c ≤ 10.5%, prior to randomization)
Fasting plasma glucose ≥ 126 mg/dL (8.3 mmo1/L) prior to randomization;

Key exclusion criteria (36 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ORMD-0801 Dose # 1Also: Oral InsulinOral Insulin Formulation	Drug	ORMD-0801 Dose # 1
ORMD-0801 Dose # 2Also: Oral InsulinOral Insulin Formulation	Drug	ORMD-0801 Dose # 2
PlaceboOil Capsules	Drug	Placebo

Primary outcome

Evaluate the Safety and Tolerability of ORMD-0801.
Time frame: Eight (8) days
Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug

4 secondary outcomes

The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)
Time frame: 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)
Time frame: Seven (7) days, and last two days (Day 6 and day 7)
The Effect of ORMD-0801 on Morning Fasting Serum Insulin
Time frame: Screening, Day 2. Day 9
The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo
Time frame: Screening, Day 2, Day 9

Results and safety

Results posted to the registry on 24 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ORMD-0801 Dose # 1	10	10
ORMD-0801 Dose # 2	10	10
Placebo	10	10

Primary outcome: Evaluate the Safety and Tolerability of ORMD-0801.

Time frame: Eight (8) days. Number. Unit: Number of Events

Measure	ORMD-0801 Dose # 1 n = 10	ORMD-0801 Dose # 2 n = 10	Placebo n = 10
Value	0	0	0

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ORMD-0801 Dose # 1	0 of 10 (0%)	3 of 10 (30%)	Not reported
ORMD-0801 Dose # 2	0 of 10 (0%)	4 of 10 (40%)	Not reported
Placebo	0 of 10 (0%)	5 of 10 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joel M Neutel, M. D. study director

Orange County Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ORMD-0801 Dose # 1 and ORMD-0801 Dose # 2 in people with Diabetes Mellitus Type 2, run by Oramed, Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the Safety and Tolerability of ORMD-0801. (time frame: Eight (8) days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01889667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.