Diabetic NeuropathiesPhase 2NCT00760955
Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral Neuropathy
A Phase 2 study testing TAK-583 in people with Diabetic Neuropathies, run by Takeda at 38 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and effectiveness of TAK-583, once daily (QD), in the treatment of neuropathy caused by diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- TAK-583
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 38 sitesin 2 countries
- Study dates
- Sep 2006to Feb 2008
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects must be post-menopausal or status post documented hysterectomy and bilateral oophorectomy.
- Has fasting clinical laboratory evaluations within the normal reference range for the testing laboratory, or if not, the results must be deemed not clinically significant by the investigator prior to randomization.
- Has Type 1 or type 2 diabetes, as defined by World Health Organization Criteria.
- Has mild to Moderate Diabetic Peripheral Neuropathy defined as:
- Confirmed abnormality of at least two nerve conduction velocity parameters as defined by the Neurological Core Laboratory.
- Sural sensory nerve potential amplitude greater than or equal to 1 μV (microvolt).
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- Has glycosylated hemoglobin less than or equal to 10%.
- Is on stable pain medications for at least 3 weeks prior to randomization, if applicable.
- Has a glomerular filtration rate calculated by Modification of Diet in Renal Disease of greater than or equal to 45 mL/min/ body surface area.
- Spot albumin/creatinine ratio of less than 300 mg/g creatinine or 33.9 mg/mmol creatinine.
- Has acceptable clinical laboratory test results as defined by:
- Hemoglobin Greater than or equal to 9.0 g/dL or 5.58 mmol/L
- Thyroid stimulating hormone Within normal limits
- Free T4 index Within normal limits
- B12 level Within normal limits
- Is willing to follow an American Diabetes Association or similar recommended dietary regimen.
Who cannot join
- Individuals with a history of other neuropathies due to causes other than diabetes such as alcohol abuse, liver or renal disease, uremia, toxic exposure, genetic factors, autoimmune disorders, inflammatory demyelinating diseases, monoclonal gammopathies; or endocrine, metabolic or nutritional disorders.
- Has clinical or electrophysiologic evidence of bilateral carpal tunnel syndrome.
- Has a significant skin abnormality or ulcerative changes in their lower extremities that may interfere with the performance of the study related procedures.
- Has a body mass index greater than 45 kg/m2.
- Participants with uncontrolled hypertension or a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure of greater than 95 mm Hg.
- Has a history of myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, clinically significant abnormal electrocardiograms, New York Heart Association Functional Classification III or IV, or documented cerebrovascular accident.
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- Has a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval greater than 450 milliseconds).
- Has a history of additional risk factors for Torsades de pointes.
- Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Medications that prolong the QT/QTc interval.
- Lipoic acid.
- Linolenic acid (primrose oil).
- Inositol.
- Topiramate.
- Acetyl-L-Carnitine.
- Nerve growth factors.
- Capsaicin.
- CYP3A4 inhibitors (amiodarone, diltiazem, Verapamil)
- HIV protease inhibitors
- Itraconazole
- Ketoconazole
- macrolide antibiotics
- CYP 3A4 inducers
- Has an alanine aminotransferase level of greater than 1.5 times upper limit of normal, active liver disease or jaundice or Total bilirubin greater than 1.2 times upper limit of normal.
- Has a 12-hour urinary cortisol test greater than 264 nmol/night (95.6 mcg/night) at screening.
- Has clinically significant (as determined by the investigator) or unstable: pulmonary, gastrointestinal, hepatic, hematologic, musculoskeletal, osteoporosis, osteopenia, or endocrine (other than diabetes mellitus or stably treated hypothyroidism) diseases.
- Has a previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug.
- Has any other serious disease or condition at screening or at randomization that might affect life expectancy or make it difficult to successfully manage and follow the subjects according to the protocol.
- Has a history of drug abuse or a history of alcohol abuse within the past 2 years.
- Has a known hypersensitivity to a compound related to TAK-583.
- Is currently participating in another investigational study or has participated in an investigational study within the past 30 days.
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States33 sites
Study site
Ann Arbor, Michigan
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Decatur, Georgia
Study site
Duncansville, Pennsylvania
Study site
Englewood, New Jersey
Study site
Greenville, North Carolina
Study site
Houston, Texas
Study site
Huntington Beach, California
Study site
Idaho Falls, Idaho
Study site
Jonesboro, Arkansas
Study site
La Jolla, California
Study site
Largo, Florida
Study site
Las Vegas, Nevada
Study site
Los Angeles, California
Study site
Mesa, Arizona
Study site
Miami, Florida
Study site
New Port Richey, Florida
Study site
Norfolk, Virginia
Study site
Palm Beach Gardens, Florida
Study site
Pasadena, California
Study site
Peoria, Arizona
Study site
Phoenix, Arizona
Study site
Portland, Oregon
Study site
San Antonio, Texas
Study site
Staten Island, New York
Study site
Sunrise, Florida
Study site
Tucson, Arizona
Study site
Tustin, California
Study site
West Palm Beach, Florida
Canada5 sites
Study site
Kingston, Ontario
Study site
Laval, Quebec
Study site
North Bay, Ontario
Study site
Québec, Quebec
Study site
Vancouver, British Columbia
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Study to Evaluate the Efficacy and Safety of 3 Doses of TAK-583 in Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
The purpose of this study is to determine the safety and effectiveness of TAK-583, once daily (QD), in the treatment of neuropathy caused by diabetes mellitus.
Read the detailed description
Diabetic polyneuropathy is a frequent complication in individuals with type 1 and 2 diabetes mellitus, and can result in progressive functional and structural deficits in both somatic and autonomic nerves. Diabetic polyneuropathy is characterized by degenerative changes in nerve fibers resulting in progressive functional and structural deficits in both somatic and autonomic nerves.
TAK-583 is a synthetic compound currently under development for the treatment of diabetic polyneuropathy. The purpose of this study is to evaluate the safety and efficacy of TAK-583 for the treatment of mild to moderate diabetic polyneuropathy in subjects with type 1 or type 2 diabetes mellitus. Study participation is anticipated to be about 8 months.
- Conditions
- Diabetic Neuropathies
- Being tested
- TAK-583, Placebo
- Keywords
- Asymmetric Diabetic Proximal Motor Neuropathy, Diabetic Amyotrophy, Diabetic Autonomic Neuropathy, Diabetic Polyneuropathy, Neuralgia, Diabetic, Symmetric Diabetic Proximal Motor Neuropathy, Drug Therapy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-583Drug
TAK-583 5 mg, tablets, orally, once daily for up to 6 months.
TAK-583Drug
TAK-583 50 mg, tablets, orally, once daily for up to 6 months.
TAK-583Drug
TAK-583 100 mg, tablets, orally, once daily for up to 6 months.
PlaceboDrug
TAK-583 placebo-matching tablets, orally, once daily for up to 6 months.
| Study group | Role | What they receive |
|---|---|---|
| TAK-583 5 mg QD | Experimental | Not described Receives: Drug: TAK-583 |
| TAK-583 50 mg QD | Experimental | Not described Receives: Drug: TAK-583 |
| TAK-583 100 mg QD | Experimental | Not described Receives: Drug: TAK-583 |
| Placebo QD | 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 for a composite measure of Maximal Nerve Conduction Velocity of the Peroneal and Median Motor Nerves and the Median and Sural Sensory Nerves.
Measured: Month 6 or Final Visit
Secondary outcomes (10)
Change from Baseline in Electrophysiological Parameters for Individual Nerves.
Measured: Month 6 or Final Visit
Change from Baseline in Sensory Sub-Composite and Motor Sub-Composite Scores.
Measured: Months 3 and 6 or Final Visit
Change in Vibration Perception Threshold.
Measured: Months 3 and 6 or Final Visit
Change in Pain Scores.
Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change in Neurological Examination Score.
Measured: Months 3 and 6 or Final Visit
Change in Quality of Life Index Score.
Measured: Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change in glycosylated hemoglobin.
Measured: Months 3 and 6 or Final Visit
Change in fasting plasma glucose.
Measured: Months 3 and 6 or Final Visit
Change in fasting insulin.
Measured: Months 3 and 6 or Final Visit
Change in Fasting C-peptide.
Measured: Months 3 and 6 or Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- VP Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760955
- Sponsor's protocol ID
- 01-06-TL-583-006
- Other IDs
- U1111-1129-7781
- Status last verified
- Jun 2016
- First submitted
- 24 Sep 2008
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Study to Evaluate the Efficacy and Safety of 3 Doses of TAK-583 in Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00760955
- Acronym / sponsor ID
- 01-06-TL-583-006
- Conditions
- Diabetic Neuropathies
- Keywords
- Asymmetric Diabetic Proximal Motor Neuropathy, Diabetic Amyotrophy, Diabetic Autonomic Neuropathy, Diabetic Polyneuropathy, Neuralgia, Diabetic, Symmetric Diabetic Proximal Motor Neuropathy, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 26 Sep 2008 (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.
The purpose of this study is to determine the safety and effectiveness of TAK-583, once daily (QD), in the treatment of neuropathy caused by diabetes mellitus.
Detailed description
Diabetic polyneuropathy is a frequent complication in individuals with type 1 and 2 diabetes mellitus, and can result in progressive functional and structural deficits in both somatic and autonomic nerves. Diabetic polyneuropathy is characterized by degenerative changes in nerve fibers resulting in progressive functional and structural deficits in both somatic and autonomic nerves.
TAK-583 is a synthetic compound currently under development for the treatment of diabetic polyneuropathy. The purpose of this study is to evaluate the safety and efficacy of TAK-583 for the treatment of mild to moderate diabetic polyneuropathy in subjects with type 1 or type 2 diabetes mellitus. Study participation is anticipated to be about 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TAK-583 5 mg QD | Experimental | Drug: TAK-583 |
| TAK-583 50 mg QD | Experimental | Drug: TAK-583 |
| TAK-583 100 mg QD | Experimental | Drug: TAK-583 |
| Placebo QD | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female subjects must be post-menopausal or status post documented hysterectomy and bilateral oophorectomy.
- Has fasting clinical laboratory evaluations within the normal reference range for the testing laboratory, or if not, the results must be deemed not clinically significant by the investigator prior to randomization.
- Has Type 1 or type 2 diabetes, as defined by World Health Organization Criteria.
- Has mild to Moderate Diabetic Peripheral Neuropathy defined as:
- Has glycosylated hemoglobin less than or equal to 10%.
Key exclusion criteria (31 listed)
- Individuals with a history of other neuropathies due to causes other than diabetes such as alcohol abuse, liver or renal disease, uremia, toxic exposure, genetic factors, autoimmune disorders, inflammatory demyelinating diseases, monoclonal gammopathies; or endocrine, metabolic or nutritional disorders.
- Has clinical or electrophysiologic evidence of bilateral carpal tunnel syndrome.
- Has a significant skin abnormality or ulcerative changes in their lower extremities that may interfere with the performance of the study related procedures.
- Has a body mass index greater than 45 kg/m2.
- Participants with uncontrolled hypertension or a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure of greater than 95 mm Hg.
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 |
|---|---|---|
| TAK-583TAK-583 5 mg, tablets, orally, once daily for up to 6 months. | Drug | TAK-583 5 mg QD |
| TAK-583TAK-583 50 mg, tablets, orally, once daily for up to 6 months. | Drug | TAK-583 50 mg QD |
| TAK-583TAK-583 100 mg, tablets, orally, once daily for up to 6 months. | Drug | TAK-583 100 mg QD |
| PlaceboTAK-583 placebo-matching tablets, orally, once daily for up to 6 months. | Drug | Placebo QD |
Primary outcome
Change from Baseline for a composite measure of Maximal Nerve Conduction Velocity of the Peroneal and Median Motor Nerves and the Median and Sural Sensory Nerves.
Time frame: Month 6 or Final Visit
10 secondary outcomes
Change from Baseline in Electrophysiological Parameters for Individual Nerves.
Time frame: Month 6 or Final Visit
Change from Baseline in Sensory Sub-Composite and Motor Sub-Composite Scores.
Time frame: Months 3 and 6 or Final Visit
Change in Vibration Perception Threshold.
Time frame: Months 3 and 6 or Final Visit
Change in Pain Scores.
Time frame: Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change in Neurological Examination Score.
Time frame: Months 3 and 6 or Final Visit
Change in Quality of Life Index Score.
Time frame: Months 1, 2, 3, 4, 5, and 6 or Final Visit
Change in glycosylated hemoglobin.
Time frame: Months 3 and 6 or Final Visit
Change in fasting plasma glucose.
Time frame: Months 3 and 6 or Final Visit
Change in fasting insulin.
Time frame: Months 3 and 6 or Final Visit
Change in Fasting C-peptide.
Time frame: Months 3 and 6 or Final Visit
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 22 Jun 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.
VP Clinical Science study director
Takeda
38 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 TAK-583 in people with Diabetic Neuropathies, run by Takeda at 38 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 16 inclusion and 31 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 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada. 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 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?
Change from Baseline for a composite measure of Maximal Nerve Conduction Velocity of the Peroneal and Median Motor Nerves and the Median and Sural Sensory Nerves. (time frame: Month 6 or Final Visit). 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 22 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.