Diabetic NeuropathiesPhase 2NCT00756041
Safety Study of TAK-128 in Subjects With Diabetic Peripheral Neuropathy
A Phase 2 study testing TAK-128 in people with Diabetic Neuropathies, run by Takeda.
Trial summary
The purpose of this study is to determine the safety of TAK-128, once daily (QD), for treatment of diabetic peripheral neuropathy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- TAK-128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Sep 2006
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has successfully completed protocol 01-04-TL-128-003.
- Female subjects of childbearing potential must be nonpregnant, nonlactating and on an acceptable form of contraception.
- Must be in good health at Enrollment, as determined by a physician at the Month 6 Visit of Protocol 01-04-TL-128-003 (ie, via medical history and physical examination).
- Has clinical laboratory evaluations within the normal reference range for the testing laboratory, unless the results are deemed not clinically significant by the investigator or sponsor, at the Month 6 Visit of Protocol 01-04-TL-128-003.
- Has a creatinine level less than or equal to 2 mg/dL or 176.8 umol/L.
- The subject is willing to follow an American Diabetes Association or similar recommended dietary regimen.
Who cannot join
- Has developed other neuropathies due to causes other than diabetes such as alcohol abuse liver or renal disease, uremia, toxic exposure, genetic factors, inflammatory demyelinating diseases, monoclonal gammopathies; or endocrine, metabolic or nutritional disorders (included treated or untreated pernicious anemia).
- Has a systolic blood pressure greater than 160 mm HG or diastolic blood pressure is greater than 95 mm HG.
- The subject has an alanine aminotransferase level of greater than 1.5 times the upper limit of normal, active liver disease, or jaundice.
- Has a significant, actively treated or unstable pulmonary, cardiovascular, gastrointestinal, hepatic, hematologic, musculoskeletal, or endocrine (other than diabetes mellitus or stably treated hypothyroidism) disease.
- Cannot use any of the following prescription medications throughout the duration of the study, including:
- Lipoic acid.
Show all 13Show fewer
- Linolenic acid (primrose oil).
- Inositol.
- Topiramate.
- Acetyl-L-Carnitine.
- Nerve growth factors.
- Capsaicin.
- Has any other serious disease or condition at the Month 6 Visit of Protocol 01-04-TL-128-003 or at the Baseline/Rollover Visit that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.
About this study
Official title: An Open-Label, Multi-Center Study to Evaluate the Safety of Long-Term Administration of TAK-128 in Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
The purpose of this study is to determine the safety of TAK-128, once daily (QD), for treatment of diabetic peripheral neuropathy
Read the detailed description
Polyneuropathy is a frequent complication of diabetes; it affects most individuals after prolonged hyperglycemia, and diabetic neuropathy is very common in the developed world. Chronic, insidious, distal sensorimotor polyneuropathy with autonomic impairment is the most typical form of diabetic neuropathy. Less common, but more florid presentations include autonomic symptoms or painful neuropathy. Although many patients have no or relatively few symptoms, the chronic polyneuropathy and autonomic dysfunction predispose to neurotrophic foot ulceration; consequently, diabetes is the leading cause of amputation today.
Diabetic neuropathy is a dying-back polyneuropathy with distal degeneration of the longest nerve fibers advancing in a centripetal direction. Multiple histopathological changes are observed, but progressive fiber loss is the hallmark of diabetic polyneuropathy. Other important features include endothelial cell basement membrane thickening, segmental demyelination and remyelination, and axonal atrophy. Similar pathological changes are observed in type 1 and type 2 diabetes. The severity of neuropathy as indicated by the stage of nerve fiber loss determines the clinical, electrophysiological, and quantitative sensory threshold features of this disorder. The functional measures of electrophysiological and quantitative sensory thresholds reflect the morphological changes and the clinical features.
Diabetic polyneuropathy is etiologically related to prolonged hyperglycemia with multiple consequences. Although strict glycemic control prevents neuropathy in type 1 patients if maintained for many years, similar interventions in those with type 2 diabetes mellitus are less successful. Type 2 patients may have neuropathy with considerable nerve fiber loss at the time of diagnosis because of unsuspected hyperglycemia in preceding years. Reversal of established neuropathy with strict glycemic control is not certain to occur, even if maintained for many years. Co-morbid disease often interferes with strict management of type 2 diabetes. Even among those with type 1 diabetes, a minority of patients are successful in maintaining prolonged euglycemia.
TAK-128 is a novel synthetic compound being developed as a treatment for diabetic neuropathy. Subjects participating in this study successfully completed Protocol 01-04-TL-128-003, and earlier study of TAK-128.
- Conditions
- Diabetic Neuropathies
- Being tested
- TAK-128
- Keywords
- Diabetic Mononeuropathy, Diabetic Neuralgia, Mononeuropathy, Diabetic, Neuralgia, Diabetic, Diabetic Polyneuropathy, 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-128Drug
TAK-128 100 mg tablet, orally, once daily for up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| TAK-128 100 mg QD | Experimental | Not described Receives: Drug: TAK-128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events, vital signs and physical examination findings.
Measured: At each visit
Clinical Laboratory Tests (Hematology, Chemistry and Urinalysis).
Measured: At each visit
Electrocardiogram results.
Measured: At each visit
Weight.
Measured: At each visit
Secondary outcomes (6)
Change from Baseline in composite nerve conduction velocities (Electrophysiologic Studies).
Measured: Months 6 and 12 or Final Visit
Change from Baseline in the electrophysiologic parameters for individual nerves, including amplitudes (Nerve Conduction Studies).
Measured: Months 6 and 12 or Final Visit
Change from Baseline in vibration perception threshold measurements (Quantitative Sensory Testing).
Measured: Month 3, 6, 9 and 12 or Final Visit
Change from Baseline in neurological examination (Clinical Neurologic Examination).
Measured: Month 3, 6, 9 and 12 or Final Visit
Change from Baseline in pain scores (Short-Form McGill Pain Questionnaire).
Measured: Month 3, 6, 9 and 12 or Final Visit
Change from Baseline in quality of life index as assessed by the Short-Form, 36-Item Health Survey.
Measured: Month 3, 6, 9 and 12 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 posted19 Sep 2008 (estimated)
- Study startSep 2005
- Primary completionSep 2006
- Study completionSep 2006
Why it stopped: Lack of Efficacy.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756041
- Sponsor's protocol ID
- 01-05-TL-128-006
- Other IDs
- U1111-1128-5801
- Status last verified
- Feb 2012
- First submitted
- 17 Sep 2008
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Study to Evaluate the Safety of Long-Term Administration of TAK-128 in Subjects With Mild to Moderate Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00756041
- Acronym / sponsor ID
- 01-05-TL-128-006
- Conditions
- Diabetic Neuropathies
- Keywords
- Diabetic Mononeuropathy, Diabetic Neuralgia, Mononeuropathy, Diabetic, Neuralgia, Diabetic, Diabetic Polyneuropathy, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Efficacy.
- Enrolment
- 221 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 19 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 of TAK-128, once daily (QD), for treatment of diabetic peripheral neuropathy
Detailed description
Polyneuropathy is a frequent complication of diabetes; it affects most individuals after prolonged hyperglycemia, and diabetic neuropathy is very common in the developed world. Chronic, insidious, distal sensorimotor polyneuropathy with autonomic impairment is the most typical form of diabetic neuropathy. Less common, but more florid presentations include autonomic symptoms or painful neuropathy. Although many patients have no or relatively few symptoms, the chronic polyneuropathy and autonomic dysfunction predispose to neurotrophic foot ulceration; consequently, diabetes is the leading cause of amputation today.
Diabetic neuropathy is a dying-back polyneuropathy with distal degeneration of the longest nerve fibers advancing in a centripetal direction. Multiple histopathological changes are observed, but progressive fiber loss is the hallmark of diabetic polyneuropathy. Other important features include endothelial cell basement membrane thickening, segmental demyelination and remyelination, and axonal atrophy. Similar pathological changes are observed in type 1 and type 2 diabetes. The severity of neuropathy as indicated by the stage of nerve fiber loss determines the clinical, electrophysiological, and quantitative sensory threshold features of this disorder. The functional measures of electrophysiological and quantitative sensory thresholds reflect the morphological changes and the clinical features.
Diabetic polyneuropathy is etiologically related to prolonged hyperglycemia with multiple consequences. Although strict glycemic control prevents neuropathy in type 1 patients if maintained for many years, similar interventions in those with type 2 diabetes mellitus are less successful. Type 2 patients may have neuropathy with considerable nerve fiber loss at the time of diagnosis because of unsuspected hyperglycemia in preceding years. Reversal of established neuropathy with strict glycemic control is not certain to occur, even if maintained for many years. Co-morbid disease often interferes with strict management of type 2 diabetes. Even among those with type 1 diabetes, a minority of patients are successful in maintaining prolonged euglycemia.
TAK-128 is a novel synthetic compound being developed as a treatment for diabetic neuropathy. Subjects participating in this study successfully completed Protocol 01-04-TL-128-003, and earlier study of TAK-128.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-128 100 mg QD | Experimental | Drug: TAK-128 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has successfully completed protocol 01-04-TL-128-003.
- Female subjects of childbearing potential must be nonpregnant, nonlactating and on an acceptable form of contraception.
- Must be in good health at Enrollment, as determined by a physician at the Month 6 Visit of Protocol 01-04-TL-128-003 (ie, via medical history and physical examination).
- Has clinical laboratory evaluations within the normal reference range for the testing laboratory, unless the results are deemed not clinically significant by the investigator or sponsor, at the Month 6 Visit of Protocol 01-04-TL-128-003.
- Has a creatinine level less than or equal to 2 mg/dL or 176.8 umol/L.
Key exclusion criteria (13 listed)
- Has developed other neuropathies due to causes other than diabetes such as alcohol abuse liver or renal disease, uremia, toxic exposure, genetic factors, inflammatory demyelinating diseases, monoclonal gammopathies; or endocrine, metabolic or nutritional disorders (included treated or untreated pernicious anemia).
- Has a systolic blood pressure greater than 160 mm HG or diastolic blood pressure is greater than 95 mm HG.
- The subject has an alanine aminotransferase level of greater than 1.5 times the upper limit of normal, active liver disease, or jaundice.
- Has a significant, actively treated or unstable pulmonary, cardiovascular, gastrointestinal, hepatic, hematologic, musculoskeletal, or endocrine (other than diabetes mellitus or stably treated hypothyroidism) disease.
- Cannot use any of the following prescription medications throughout the duration of the study, including:
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-128TAK-128 100 mg tablet, orally, once daily for up to 1 year. | Drug | TAK-128 100 mg QD |
Primary outcome
Treatment-emergent adverse events, vital signs and physical examination findings.
Time frame: At each visit
Clinical Laboratory Tests (Hematology, Chemistry and Urinalysis).
Time frame: At each visit
Electrocardiogram results.
Time frame: At each visit
Weight.
Time frame: At each visit
6 secondary outcomes
Change from Baseline in composite nerve conduction velocities (Electrophysiologic Studies).
Time frame: Months 6 and 12 or Final Visit
Change from Baseline in the electrophysiologic parameters for individual nerves, including amplitudes (Nerve Conduction Studies).
Time frame: Months 6 and 12 or Final Visit
Change from Baseline in vibration perception threshold measurements (Quantitative Sensory Testing).
Time frame: Month 3, 6, 9 and 12 or Final Visit
Change from Baseline in neurological examination (Clinical Neurologic Examination).
Time frame: Month 3, 6, 9 and 12 or Final Visit
Change from Baseline in pain scores (Short-Form McGill Pain Questionnaire).
Time frame: Month 3, 6, 9 and 12 or Final Visit
Change from Baseline in quality of life index as assessed by the Short-Form, 36-Item Health Survey.
Time frame: Month 3, 6, 9 and 12 or Final Visit
Results and safety
The study was stopped early (reason given: Lack of Efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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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.
Sr. Medical Director Clinical Science study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-128 in people with Diabetic Neuropathies, run by Takeda.
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 6 inclusion and 13 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 28 Feb 2012. 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. 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: Lack of Efficacy.). 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?
Treatment-emergent adverse events, vital signs and physical examination findings. (time frame: At each visit). The study lists 4 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 28 Feb 2012.