Asian Study on Cilostazol Effectivity in Neuropathies of Diabetes Mellitus Type 2-A Pilot Study in the Philippines

To describe if there are differences in the subjective, objective and electrophysiologic parameters of diabetic polyneuropathies at baseline, four (4) weeks, eight (8) weeks, and twelve (12) weeks after Cilostazol therapy.

Intervention(s) in this Clinical Trial

• Drug: Cilostazol
  • 100 mg, 200mg tablet Cilostazol

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Arm 1
  • 2 tablets BID
• Experimental: Arm 2
  • 100 mg Cilostazol (2 tablets BID)
• Experimental: Arm 3
  • 200 mg Cilostazol (2 Tablets BID)

Primary Measures

• Subjective neuropathy assessment by NSS (Neuropathy Symptom Scores)from Baseline (BS) to week 12 (W12) after Cilostazol therapy of the three (3) arms of the study.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Objective neuropathy assessment by NIS (Neuropathy Impairment Scores)from Baseline (BS) to week 12 (W12) after Cilostazol therapy of the three (3) arms of the study.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Electrophysiologic assessment by NCS (Nerve Conduction Studies) from Baseline (BS) to week 12 (W12) after Cilostazol therapy of the three (3) arms of the study.
  • Time Frame: 12 weeks
    Safety Issue?: No
• To determine the relationship of peripheral neuropathy with peripheral vascular disease using the WIQ and the ABI from baseline to W12.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• To determine if there is improvement in subjective parameters of neuropathy as assessed by NSS and NSC (Neuropathy Symptoms and Change Questionnaire) from baseline to week 4 (W4), week 8 (W8) and week 12 (W12) after Cilostazol therapy.
  • Time Frame: 12 weeks
    Safety Issue?: No
• To determine if there is improvement in objective parameters using NIS and NCS from baseline to W4, W8 and W12 after Cilostazol therapy.
  • Time Frame: 12 weeks
    Safety Issue?: No
• To compare the effectivity of low dose (100mg) and high dose (200mg) Cilostazol based on subjective (NSS, NSC) and objective parameters (NIS, NCS) from baseline, to W4, W8 and W12.
  • Time Frame: 12 weeks
    Safety Issue?: No
• To assess the safety of Cilostazol therapy.
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. Signed written informed consent 2. Male and Female ages 18 to 70 years old. To be able to eliminate Type
• I Diabetes Mellitus among the younger subjects, we will only recruit patients who are stable on oral hypoglycemic agent.
• 3. Established diagnosis of diabetes mellitus type 2 (National Diabetes
• Data Group) who are currently on good control of the diabetic state.
• 4. Presence of predominantly distal symmetrical sensory polyneuropathy of the lower limbs as assessed by NSS, NIS and NCS.

Exclusion Criteria:

• 1. Current use of potentially neuropathic agents (Isoniazid, Phenytoin, Dapsone, Metronidazole, Vinca Alkaloids, etc.) within the past 1 month;
• 2. Presence of severe metabolic disease (renal failure, hepatic failure, etc.), alcoholism and malignancy;
• 3. Presence of hemorrhagic tendencies;
• 4. Patients who are diagnosed to be of Type 1 Diabetes Mellitus;
• 5. Pregnant and lactating patients, including those who plan to have pregnancy within the study period.
• 6. Concomitant intake of agents currently used to treat neuropathic pain like gabapentin, carbamazepine/ oxcarbazepine, anti-depressants (tricyclic anti-depressants and SSRIs) and topical capsaicin.
• 7. Concomitant intake of other anti-platelet agents, rheologic agents and anticoagulants.
• 8. Have received Cilostazol therapy within the past three (3) months

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Otsuka Pharmaceutical, Inc., Philippines Industry

Overall Clinical Trial Officials and Contacts

Raymond Rosales, MD, PhD Principal Investigator University of Santo Tomas Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01076478

Study ID Number: PLT-004-01

ClinicalTrials.gov Identifier: NCT01076478

Health Authority: Philippines: Philippine Council for Health Research and Development