Diabetes Mellitus, Type 1NCT00521378
A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Diasome Pharmaceuticals at 1 site in United States.
Trial summary
A study designed to determine the appropriate doses of Oral HDV Insulin at meal times. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2007to 6 Oct 2007
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months
Who may be able to join
- Patients must satisfy all of the following inclusion criteria to be included in the study:
- be male or female between the ages of18 and 65 years, inclusive;
- have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months;
- have a current physical examination that reveals no clinically significant abnormalities;
- have no clinically significant abnormalities in vital signs;
- have a body mass index (BMI) <38;
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- have a glycosylated hemoglobin (HbA1c) > 8 and <12;
- have a C-peptide level >3 ng/mL;
- have a typical fasting blood glucose levels of < 200 mg/dl (+/- 25 mg/dl);
- be available for the entire study period, and be able and willing to adhere to protocol requirements;
- if female of childbearing potential, must be using a reliable form of birth control; and,
- provide written informed consent prior to admission into the study.
Who cannot join
- have a history or presence of significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of insulin;
- have a history of drug or alcohol dependency or psychological disease;
- have any clinically significant illness during the 4 weeks prior to admission into the study;
- require regular use of medication that interferes with the absorption and/or metabolism of insulin;
- recent use (within 48 hours) of medications that interfere with blood glucose analyses, i.e., mannose, acetaminophen, dopamine, and ascorbic acid, which are all reported to alter glucose-oxidase type blood glucose analytical methods;
- use of Avandia or Actos for treating diabetes;
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- participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study;
- use of MAO inhibitors or enzyme-inducing or enzyme-inhibiting agents (eg, phenobarbital or carbamazepine) within 30 days prior to admission to this study;
- are pregnant or lactating; 10. have an episode of severe hypoglycemia with seizure or coma within the past year;
- 11. have a history of ketoacidosis;
- 12. have any acute illness within 2 weeks prior to Screening; or,
- 13. have elevated liver enzymes (ALT, AST, alkaline phosphatase) >1.5 times the upper limit of normal.
Trial locations and contacts
1 site in 1 country.
About this study
A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.
- Keywords
- Diabetes, Type 1 and Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose response of postprandial plasma glucose to escalated doses of oral HDV-insulin
To determine the dose response of postprandial plasma glucose to escalating doses (increased daily) of Oral HDV-Insulin given as single doses before breakfast, lunch and dinner, in addition to the Diabetes Mellitus (DM) subject's regular oral type 2 therapy
Measured: 3 weeks
Daily glucodynamic profile of Oral HDV-Insulin
To compare the daily glucodynamic profile of Oral HDV-Insulin over the treatment days
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study start17 Sep 2007
- Primary completion6 Oct 2007
- Study completion6 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diasome Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521378
- Sponsor's protocol ID
- DP 01-2007-01
- Status last verified
- May 2021
- First submitted
- 23 Aug 2007
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00521378
- Acronym / sponsor ID
- DP 01-2007-01
- Keywords
- Diabetes, Type 1 and Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Diasome PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2007 (actual)
- Primary completion
- 6 Oct 2007 (actual)
- Study completion
- 6 Oct 2007 (actual)
- First posted
- 27 Aug 2007 (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 study designed to determine the appropriate doses of Oral HDV Insulin at meal times.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months
Key inclusion criteria (12 listed)
- Patients must satisfy all of the following inclusion criteria to be included in the study:
- be male or female between the ages of18 and 65 years, inclusive;
- have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic agents for at least 3 months;
- have a current physical examination that reveals no clinically significant abnormalities;
- have no clinically significant abnormalities in vital signs;
Key exclusion criteria (12 listed)
- have a history or presence of significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of insulin;
- have a history of drug or alcohol dependency or psychological disease;
- have any clinically significant illness during the 4 weeks prior to admission into the study;
- require regular use of medication that interferes with the absorption and/or metabolism of insulin;
- recent use (within 48 hours) of medications that interfere with blood glucose analyses, i.e., mannose, acetaminophen, dopamine, and ascorbic acid, which are all reported to alter glucose-oxidase type blood glucose analytical methods;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dose response of postprandial plasma glucose to escalated doses of oral HDV-insulin
Time frame: 3 weeks
To determine the dose response of postprandial plasma glucose to escalating doses (increased daily) of Oral HDV-Insulin given as single doses before breakfast, lunch and dinner, in addition to the Diabetes Mellitus (DM) subject's regular oral type 2 therapy
Daily glucodynamic profile of Oral HDV-Insulin
Time frame: 3 weeks
To compare the daily glucodynamic profile of Oral HDV-Insulin over the treatment days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Diasome Pharmaceuticals 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 12 inclusion and 12 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 14 May 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose response of postprandial plasma glucose to escalated doses of oral HDV-insulin (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 14 May 2021.