Diabetes MellitusPhase 1ORA3NCT01114750
A Study to Determine the Absorption of Peroral Insulin in Dextran Matrix (ORA3)
A Phase 1 study of Diabetes Mellitus, run by Bows Pharmaceuticals AG at 1 site in Sweden.
Trial summary
A pharmacokinetic study on the absorption of perorally delivered insulin in dextran matrix after single dose administration. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects, age 18-40 years.
- Fasting blood glucose within the range 4.0-6.0 mmol/L at Screening, and on Day 1 before dosing ≥ 4 mmol/L. However, the subject should not be excluded from the study if the blood glucose is out of this range once the treatment period has started.
- Body Mass Index (BMI) of 20-27 kg/m2
- Medically stable as determined by history and physical examination, including vital signs.
- Screening laboratory tests must be within normal range or judged as not clinically significant by Principal investigator/Subinvestigator.
- Negative urine ketoacidosis test
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- ECG including QTcB shows no clinically significant abnormality or acute ischemia
- Supine BP ≤ 139/89 mm Hg diastolic/systolic, or at the discretion of the investigator
- Able to adhere to the study visit schedule, and to understand and comply with other protocol requirements.
- Capable of giving informed consent, which must be obtained prior to any screening procedures.
- Negative laboratory screen for Hepatitis B (HBsAg and anti-HBc antibodies), Hepatitis C (anti HCV) and HIV (1\&2).
- Willing to refrain from consuming alcohol 48 hours prior to dosing and throughout the period of sample collection.
- Not on any prohibited medication (See section 8.9), or at the discretion of the investigator.
Who cannot join
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, or any other condition which increases risk of participation in this trial in the opinion of the investigator.
- Currently known malignancy or a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been excised more than one year ago with no evidence of recurrence
- A chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (bronchiectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), open skin wound, or ulcer.
- Other medical conditions, drug treatments or significant medical problems that would preclude participation in a clinical trial that, in the opinion of the investigator, disqualifies the subject.
- Participation in a clinical trial within the prior 3 months
- History of GI surgery (other than appendectomy) or known GI motility disorders.
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- History of a serious infection, including but not limited to hepatitis, pneumonia, or pyelonephritis, or have been hospitalized or received intravenous antibiotics for an infection, during the previous two months.
- A recent adult history of clinically significant allergic reaction to any drug.
- History of polyps in the gastrointestinal tract.
- Known to have had a substance abuse (drug or alcohol) problem within the previous 5 years
- Alcohol use within 48 hours prior to visits to the study unit.
- Unable to undergo venipunctures for study purposes because of poor tolerability or lack of easy access.
- Engaging in any strenuous exercise (such as running or weight lifting or playing any team sports such as soccer) within 48 hours prior to visits to the study unit.
- Donation of plasma within 7 days prior to the first dose.
- Donation of blood within 3 months prior to the first dose
- Difficulty in swallowing capsules.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Trial Alliance (KTA), Phase I Unit
Stockholm, Stockholm County
About this study
Official title: A Placebo-controlled Study of Insulin Absorption in Healthy Volunteers After Single-dose Oral Administration of Insulin in Dextran Matrix
A pharmacokinetic study on the absorption of perorally delivered insulin in dextran matrix after single dose administration.
Read the detailed description
The study is a single blind, cross over study where each subject will receive a a single active dose (200 IU) of insulin in dextran matrix and placebo on two different experimental days.
- Conditions
- Diabetes Mellitus
- Being tested
- Insulin in dextran matrix capsule (and placebo)
- Keywords
- blood glucose, blood insulin, dextran, diabetes, hyperglycemia, hypoglycemia, oral delivery, portal delivery
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin in dextran matrix capsule (and placebo)Drug
Single dose capsule (and placebo)
| Study group | Role | What they receive |
|---|---|---|
| Oral Insulin in Dextran Matrix | Active comparator | A group consisting of male healthy volunteers will be given placebo and one single dose of insulin in dextran matrix, for estimation of post-dose relative bioavailability. Receives: Drug: Insulin in dextran matrix capsule (and placebo) |
| Placebo | Placebo comparator | A group consisting of male healthy volunteers will be given placebo and one single dose of insulin in dextran matrix, for estimation of post-dose relative bioavailability. Receives: Drug: Insulin in dextran matrix capsule (and placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variable: insulin
Estimation of insulin AUC and Cmax post dose-administration
Measured: 3-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bows Pharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nabil Al-Tawil, M.D.; Ph.D., Principal investigator, Karolinska Trial Alliance, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114750
- Sponsor's protocol ID
- ORA3-2010-019098-14
- Acronym
- ORA3
- Status last verified
- Oct 2010
- First submitted
- 29 Apr 2010
- Last updated
- 5 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Study of Insulin Absorption in Healthy Volunteers After Single-dose Oral Administration of Insulin in Dextran Matrix
- ClinicalTrials.gov ID
- NCT01114750
- Acronym / sponsor ID
- ORA3 / ORA3-2010-019098-14
- Conditions
- Diabetes Mellitus
- Keywords
- blood glucose, blood insulin, dextran, diabetes, hyperglycemia, hypoglycemia, oral delivery, portal delivery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Bows Pharmaceuticals AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 3 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pharmacokinetic study on the absorption of perorally delivered insulin in dextran matrix after single dose administration.
Detailed description
The study is a single blind, cross over study where each subject will receive a a single active dose (200 IU) of insulin in dextran matrix and placebo on two different experimental days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Insulin in Dextran Matrix | Active comparator | Drug: Insulin in dextran matrix capsule (and placebo)A group consisting of male healthy volunteers will be given placebo and one single dose of insulin in dextran matrix, for estimation of post-dose relative bioavailability. |
| Placebo | Placebo comparator | Drug: Insulin in dextran matrix capsule (and placebo)A group consisting of male healthy volunteers will be given placebo and one single dose of insulin in dextran matrix, for estimation of post-dose relative bioavailability. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy male subjects, age 18-40 years.
- Fasting blood glucose within the range 4.0-6.0 mmol/L at Screening, and on Day 1 before dosing ≥ 4 mmol/L. However, the subject should not be excluded from the study if the blood glucose is out of this range once the treatment period has started.
- Body Mass Index (BMI) of 20-27 kg/m2
- Medically stable as determined by history and physical examination, including vital signs.
- Screening laboratory tests must be within normal range or judged as not clinically significant by Principal investigator/Subinvestigator.
Key exclusion criteria (16 listed)
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, or any other condition which increases risk of participation in this trial in the opinion of the investigator.
- Currently known malignancy or a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been excised more than one year ago with no evidence of recurrence
- A chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (bronchiectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), open skin wound, or ulcer.
- Other medical conditions, drug treatments or significant medical problems that would preclude participation in a clinical trial that, in the opinion of the investigator, disqualifies the subject.
- Participation in a clinical trial within the prior 3 months
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 |
|---|---|---|
| Insulin in dextran matrix capsule (and placebo)Single dose capsule (and placebo) | Drug | Oral Insulin in Dextran Matrix, Placebo |
Primary outcome
Pharmacokinetic variable: insulin
Time frame: 3-5 hours
Estimation of insulin AUC and Cmax post dose-administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
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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.
Nabil Al-Tawil, M.D.; Ph.D. principal investigator
Karolinska Trial Alliance, Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Diabetes Mellitus, run by Bows Pharmaceuticals AG at 1 site in Sweden.
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 13 inclusion and 16 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: paused, as of the sponsor's last update on 5 Oct 2010. 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 Sweden. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Pharmacokinetic variable: insulin (time frame: 3-5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2010.