AzTrials
AzTrials

Diabetic NeuropathiesPhase 2NCT00229437

Efficacy and Safety Study of TAK-128 in Treating Subjects With Diabetic Peripheral Neuropathy

A Phase 2 study testing TAK-128 in people with Diabetic Neuropathies, run by Takeda at 48 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the efficacy and safety of TAK-128, once daily (QD), in treating subjects with 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?
Yes, some participants may receive a placebo
How many people
343 participants
Where
48 sitesin 2 countries
Study dates
Mar 2005to May 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

  • Female subjects of childbearing potential must be nonpregnant, nonlactating and on an acceptable form of contraception.
  • The subject 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.
  • The subject has type 1 or 2 diabetes mellitus using World Health Organization Criteria.
  • The subject has mild to moderate peripheral neuropathy defined as:
  • Clinical neuropathy score greater than or equal to 2.5 on the Michigan Neuropathy Screening Instrument.
  • Confirmed abnormality of at least 2 nerve conduction study velocity parameters as defined by the Neurological Core Laboratory.
Show all 12Show fewer
  • Sural sensory nerve potential amplitude greater than or equal to 1 microvolt.
  • The subject's glycosylated hemoglobin is less than or equal to 10%.
  • The subject is on stable diabetic therapy for at least 3 months prior to randomization.
  • The subject is on stable pain medication for at least 6 weeks prior to randomization, if applicable.
  • The subject's creatinine level is 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

  • The subject has a history of 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).
  • The subject has clinical or electrophysiologic evidence of bilateral carpal tunnel syndrome.
  • The subject has a significant skin abnormality or ulcerative changes in their lower extremities.
  • The subject's body mass index is greater than 40 kg/m2.
  • The subject's systolic blood pressure is greater than 160 mm Hg or diastolic blood pressure is greater than 95 mm Hg.
  • The subject has a history of myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, significant electrocardiograms, or documented cerebrovascular accident within 6 months prior to Screening, or is New York Heart Association Functional Cardiac Classification III or IV.
Show all 22Show fewer
  • The subject has an alanine aminotransferase level of greater than 1.5 times the upper limit of normal, active liver disease, or jaundice.
  • The subject has a significant, actively treated or unstable pulmonary, gastrointestinal, hepatic, hematologic, musculoskeletal, or endocrine (other than diabetes mellitus or stably treated hypothyroidism) disease.
  • The subject has a previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug.
  • The subject has taken lipoic acid, linolenic acid (primrose oil), inositol, topiramate, Acetyl-L-Carnitine, nerve growth factors, or capsaicin within 30 days prior to Screening.
  • The subject 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 subject according to the protocol.
  • The subject has a history of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
  • The subject has a known hypersensitivity to a compound related to TAK-128.
  • Subjects can not use any of the following prescription medications throughout the duration of the study, including:
  • Lipoic acid
  • Linolenic acid (primrose oil)
  • Inositol
  • Topiramate
  • Acetyl-L-Carnitine
  • Nerve growth factors
  • Capsaicin
  • The subject currently is participating in another investigational study or has participated in an investigational study within the past (30 days or 5 half lives, whichever is longer).

Trial locations and contacts

48 sites in 2 countries.

48 sites in 2 countries

United States40 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Aventura, Florida

  • Study site

    Boston, Massachusetts

  • Study site

    Buffalo, New York

  • Study site

    Chicago, Illinois

  • Study site

    Dallas, Texas

  • Study site

    Decatur, Georgia

  • Study site

    Elizabeth, New Jersey

  • Study site

    Flint, Michigan

  • Study site

    Fort Myers, Florida

  • Study site

    Greenville, North Carolina

  • Study site

    Hialeah, Florida

  • Study site

    Houston, Texas

  • Study site

    Huntington Beach, California

  • Study site

    La Jolla, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Morrisville, Pennsylvania

  • Study site

    New Brunswick, New Jersey

  • Study site

    New Orleans, Louisiana

  • Study site

    Norfolk, Virginia

  • Study site

    Northridge, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Palm Beach Gardens, Florida

  • Study site

    Peoria, Arizona

  • Study site

    Phoenix, Arizona

  • Study site

    Plant City, Florida

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California

  • Study site

    St Louis, Missouri

  • Study site

    Staten Island, New York

  • Study site

    Tacoma, Washington

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    Tustin, California

Other trials in United States

Canada8 sites

  • Study site

    Calgary, Alberta

  • Study site

    Gatineau, Quebec

  • Study site

    Kingston, Ontario

  • Study site

    Laval, Quebec

  • Study site

    North Bay, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Sarina, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Three Doses of TAK-128 in Subjects With Mild to Moderate Diabetic Peripheral Neuropathy

The purpose of this study is to determine the efficacy and safety of TAK-128, once daily (QD), in treating subjects with 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.

Being tested
TAK-128, Placebo
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 5 mg, tablets, orally, once daily for up to 6 months.

  • TAK-128Drug

    TAK-128 50 mg, tablets, orally, once daily for up to 6 months.

  • TAK-128Drug

    TAK-128 100 mg, tablets, orally, once daily for up to 6 months.

  • PlaceboDrug

    TAK-128 placebo-matching tablets, orally, once daily for up to 6 months.

Study groups in NCT00229437
Study groupRoleWhat they receive
TAK-128 5 mg QDExperimentalNot described
Receives: Drug: TAK-128
TAK-128 50 mg QDExperimentalNot described
Receives: Drug: TAK-128
TAK-128 100 mg QDExperimentalNot described
Receives: Drug: TAK-128
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in composite measure of maximal nerve conduction velocity (Nerve Conduction Studies).

    Measured: Week 24 or Final Visit

Secondary outcomes (5)

  1. Change from Baseline in the electrophysiologic parameters for individual nerves, including amplitudes (Nerve Conduction Studies).

    Measured: Week 24 or Final Visit

  2. Change from Baseline in vibration perception threshold measurements (Quantitative Sensory Testing).

    Measured: Weeks 12, 24 or Final Visit

  3. Change from Baseline in pain scores (Short-Form McGill Pain Questionnaire).

    Measured: Weeks: 8, 12, 16, 20, 24 or Final Visit

  4. Change from Baseline in the neurological examination (Clinical Neurological Examination).

    Measured: Weeks 12, 24 or Final Visit

  5. Change from Baseline in quality of life index (SF-36 Health Survey).

    Measured: Weeks: 8, 12, 16, 20, 24 or Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionMay 2006
  4. Study completionMay 2006

Resources

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
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00229437
Sponsor's protocol ID
01-04-TL-128-003
Other IDs
U1111-1128-5843
Status last verified
Feb 2012
First submitted
27 Sep 2005
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

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 at 48 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 12 inclusion and 22 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 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 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 in composite measure of maximal nerve conduction velocity (Nerve Conduction Studies). (time frame: Week 24 or Final Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00229437.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in