Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT)

UMIN ID: UMIN000000615

Registered date:20/02/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Diabetic peripheral neuropathy
• Date of first enrollment: 1997/04/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Epalrestat(50mg) was orally administered three times daily before each meal (150 mg/day) with conventional therapies
Conventional therapy (diet treatment, hypoglycemic agents, insulin, and hypotensive agents)

Outcome(s)

• Primary Outcome: Change from baseline in median MNCV at 3 years
• Secondary Outcome: Other somatic nerve function parameters (minimum F-wave latency [MFWL] of the median motor nerve and vibration perception threshold [VPT]), cardiovascular autonomic nerve function and subjective symptoms

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Subjects were excluded if their primary cause of neurologic disorder was not diabetes (alcoholic neuropathy, carpal tunnel syndrome, sequelae of cerebrovascular disease, etc.), if they had arteriosclerosis obliterans (ankle brachial pressure index of <=0.8), or severe hepatic or renal disorder, if they were participating in other interventional studies, or if they were receiving other experimental medications for diabetic neuropathy, prostaglandin E1 preparations, or any other medication that affects symptoms of diabetic neuropathy.

Related Information

• Primary Sponsor: The Aldose Reductase Inhibitor-Diabetes Complications Trial (ADCT) Study Group
• Source(s) of Monetary Support: Ono Pharmaceutical Co., Ltd