Diabetes Mellitus, Type 1Phase 2NCT00557518
Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
A Phase 2 study testing Alagebrium in people with Diabetes Mellitus, Type 1 and Diabetic Nephropathy, run by Synvista Therapeutics, Inc at 6 sites in 2 countries.
Trial summary
Based upon the preclinical evidence in models of diabetic nephropathy under conditions approximating both type I and II diabetes, treatment with alagebrium appears to have favorable and advantageous effects on the biochemical, structural, pathological and functional hallmarks of diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetic Nephropathy
- What is being tested?
- Alagebrium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Nov 2007to Nov 2009
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insulin-dependent type 1 diabetes
- Age 18-65 years
- Diagnosis of established microalbuminuria
- Blood pressure <140 mm Hg, diastolic blood pressure <90 mm Hg
- HbA1c <10%
Who cannot join
- Body mass index >40 kg/m2
- Cardiovascular event within 6 months prior to screening
- History of acute myocardial infarction within 12 months prior to screening
- Serum creatinine >1.5 mg/dL
- Receiving chronic nonsteroidal anti-inflammatory therapy
- Receiving antihypertensive therapy except for angiotensin converting enzyme inhibitors or angiotensin receptor blockers
- Any significant systemic illnesses,medical conditions or abnormal laboratory values
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia5 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
International Diabetes Institute
Caulfield, Victoria, 3162
Dept. of Clinical and Biomedical Science Myers House
Geelong, Victoria, 3220
Austin Health
Heidelburg, Victoria, 3084
The Alfred Hospital
Melbourne, Victoria, 3004
About this study
Official title: A Randomized, Placebo-Controlled Trial of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
Based upon the preclinical evidence in models of diabetic nephropathy under conditions approximating both type I and II diabetes, treatment with alagebrium appears to have favorable and advantageous effects on the biochemical, structural, pathological and functional hallmarks of diabetic nephropathy. The renoprotective effects of alagebrium in preclinical models favor the evaluation of this drug in patients with type I diabetes.
Read the detailed description
This study is a double-blind, randomized, placebo-controlled, parallel design trial enrolling 80 patients (2x40) with Type 1 diabetes and microalbuminuria. Patients will be randomized to either 200 mg Alagebrium twice daily or placebo for a period of 24 weeks after an 8 week run-in period. There will be a 8 week run-out period. All patients will receive ramipril during the entire study period. Efficacy measurements will be performed at baseline, at 12 weeks and at the end of the study. Measurements for albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers and 24 hour blood pressure measurements will also be determined. A total of 9 visits will be performed during the entire study.
- Conditions
- Diabetes Mellitus, Type 1, Diabetic Nephropathy
- Being tested
- Alagebrium, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlagebriumDrug
Also called ALT-711
200 mg bid
PlaceboDrug
bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Alagebrium |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in albumin excretion rate (µg/min)
Measured: 24 weeks
Secondary outcomes (1)
Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2009 (estimated)
- Study completionNov 2009 (estimated)
Why it stopped: Study has been terminated early due to financial constraints.
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
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synvista Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Investigators
- Mark E Cooper, MBBS, PhD, Study chair, Baker Heart Research Institute, Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557518
- Sponsor's protocol ID
- ALT-711-0424
- Status last verified
- Jan 2009
- First submitted
- 12 Nov 2007
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Trial of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
- ClinicalTrials.gov ID
- NCT00557518
- Acronym / sponsor ID
- ALT-711-0424
- Conditions
- Diabetes Mellitus, Type 1, Diabetic Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been terminated early due to financial constraints.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Synvista Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 14 Nov 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.
Based upon the preclinical evidence in models of diabetic nephropathy under conditions approximating both type I and II diabetes, treatment with alagebrium appears to have favorable and advantageous effects on the biochemical, structural, pathological and functional hallmarks of diabetic nephropathy. The renoprotective effects of alagebrium in preclinical models favor the evaluation of this drug in patients with type I diabetes.
Detailed description
This study is a double-blind, randomized, placebo-controlled, parallel design trial enrolling 80 patients (2x40) with Type 1 diabetes and microalbuminuria. Patients will be randomized to either 200 mg Alagebrium twice daily or placebo for a period of 24 weeks after an 8 week run-in period. There will be a 8 week run-out period. All patients will receive ramipril during the entire study period. Efficacy measurements will be performed at baseline, at 12 weeks and at the end of the study. Measurements for albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers and 24 hour blood pressure measurements will also be determined. A total of 9 visits will be performed during the entire study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Alagebrium |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Insulin-dependent type 1 diabetes
- Age 18-65 years
- Diagnosis of established microalbuminuria
- Blood pressure <140 mm Hg, diastolic blood pressure <90 mm Hg
- HbA1c <10%
Key exclusion criteria (7 listed)
- Body mass index >40 kg/m2
- Cardiovascular event within 6 months prior to screening
- History of acute myocardial infarction within 12 months prior to screening
- Serum creatinine >1.5 mg/dL
- Receiving chronic nonsteroidal anti-inflammatory therapy
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 |
|---|---|---|
| AlagebriumAlso: ALT-711200 mg bid | Drug | 1 |
| Placebobid | Drug | 2 |
Primary outcome
Change from baseline in albumin excretion rate (µg/min)
Time frame: 24 weeks
1 secondary outcome
Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Study has been terminated early due to financial constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
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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.
Mark E Cooper, MBBS, PhD study chair
Baker Heart Research Institute, Melbourne, Australia
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alagebrium in people with Diabetes Mellitus, Type 1 and Diabetic Nephropathy, run by Synvista Therapeutics, Inc at 6 sites in 2 countries.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Denmark. 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?
The study was stopped early (reason given: Study has been terminated early due to financial constraints.). 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?
Change from baseline in albumin excretion rate (µg/min) (time frame: 24 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 30 Jan 2009.