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

• Status: Terminated
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of TAK-128, once daily (QD), for treatment of diabetic peripheral neuropathy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.