Diabetic NephropathyPhase 1/2NCT00544934
Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects
A Phase 1/2 study testing GLY-230 in people with Diabetic Nephropathy, run by Glycadia.
Trial summary
A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- GLY-230
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Oct 2007
- Phase
- Phase 1/2
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent
Who cannot join
- Sctive concomitant serious medical or surgical disease
About this study
Official title: A Dose-ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects
A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects
- Conditions
- Diabetic Nephropathy
- Being tested
- GLY-230, Placebo
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLY-230Drug
125, 250 0r 375 mg bid for 14 days
PlaceboOther
No drug administered
| Study group | Role | What they receive |
|---|---|---|
| 250 mg | Experimental | Not described Receives: Drug: GLY-230 |
| 500 mg | Experimental | Not described Receives: Drug: GLY-230 |
| 750 mg | Experimental | Not described Receives: Drug: GLY-230 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated albumimin concentration
Measured: three weeks
Secondary outcomes (1)
urine albumin
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startFeb 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycadia
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Laurence Kennedy, M.D., Principal investigator, University of FloridaMaria del Pilar Solano, M.D., Principal investigator, University of Miami, Miami, FloridaLis Cohen, D.O., Principal investigator, Suncoast Clinical Research, New Port Richey, Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544934
- Sponsor's protocol ID
- GLY-002
- Status last verified
- Feb 2016
- First submitted
- 15 Oct 2007
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects
- ClinicalTrials.gov ID
- NCT00544934
- Acronym / sponsor ID
- GLY-002
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GlycadiaIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 16 Oct 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 dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 250 mg | Experimental | Drug: GLY-230 |
| 500 mg | Experimental | Drug: GLY-230 |
| 750 mg | Experimental | Drug: GLY-230 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent
Key exclusion criteria (1 listed)
- Sctive concomitant serious medical or surgical disease
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 |
|---|---|---|
| GLY-230125, 250 0r 375 mg bid for 14 days | Drug | 250 mg, 500 mg, 750 mg |
| PlaceboNo drug administered | Other | Placebo |
Primary outcome
glycated albumimin concentration
Time frame: three weeks
1 secondary outcome
urine albumin
Time frame: three weeks
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 10 Feb 2016.
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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.
Laurence Kennedy, M.D. principal investigator
University of Florida
Maria del Pilar Solano, M.D. principal investigator
University of Miami, Miami, Florida
Lis Cohen, D.O. principal investigator
Suncoast Clinical Research, New Port Richey, Florida
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GLY-230 in people with Diabetic Nephropathy, run by Glycadia.
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 1 inclusion and 1 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 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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?
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?
glycated albumimin concentration (time frame: three weeks). 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 10 Feb 2016.