Multicenter Collaborative Prospective Exploratory Study on Diabetic Peripheral Neuropathic Pain (Multicenter Collaborative Prospective Exploratory Study on Diabetic Peripheral Neuropathic Pain)
Dia-NeP study (Dia-NeP study)
Kamiya Hideki
Aichi Medical University Hospital
1-1, Yazakokarimata, Nagakute-shi, AICHI
+81-561-62-3311
hkamiya@aichi-med-u.ac.jp
Kamiya Hideki
Aichi Medical University Hospital
1-1, Yazakokarimata, Nagakute-shi, AICHI
+81-561-62-3311
hkamiya@aichi-med-u.ac.jp
Not Recruiting
Mar. 25, 2025
Mar. 31, 2025
3000
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
<Baseline survey (primary enrollment)>
1. Outpatients with a diagnosis of type 2 diabetes mellitus at the time of informed consent
2. Patients aged 18 years or older at the time of informed consent
3. Patients who gave written consent based on the patient's own free will
<Mirogabalin intervention study (secondary enrollment)>
1. Patients diagnosed with DPNP at the baseline survey*1 and having a pain NRS*3 of 1 or higher based on subjective symptoms*2 of DPN at the time of secondary entry.
*1: Diagnosis of DPN is made using the "Simplified Diagnostic Criteria for Diabetic Polyneuropathy" in Table 1-a of Chapter 10 of the 2024 Diabetes Treatment Guidelines, and based on this diagnosis, DPNP is diagnosed.
*2: Subjective symptoms based on DPN at the time of secondary entry are defined as 1) bilateral, 2) numbness, pain, and paresthesia of the toes and soles (but not only paresthesia), and 3) no symptoms of the upper extremities alone. 2) "Numbness," "pain," and "paresthesia" of the toe tip and sole are read based on "Subjective symptoms probably based on diabetic neuropathy" (Appendix 3) from the neuropathy questionnaire collected from the study subjects.
*3:Pain NRS:An index that evaluates the intensity of pain on an 11-point scale from 0 to 10.
<Baseline survey (primary enrollment)>
1. Patients who are judged by the investigator to be inappropriate as research subjects
<Mirogabalin intervention study (secondary enrollment)>
Patients who meet any of the following criteria at secondary entry will be excluded.
1. Patients who do not wish to participate in the mirogabalin intervention study
2. Patients who are considered to be hospitalized
3. Subjects with severe pain due to diseases other than DPNP and considered difficult to assess
4. Patients taking research drugs and prohibited concomitant drugs within 28 days before secondary enrollment
5. Individuals with creatinine clearance (CLcr) below 30 mL/min*
6. Patients with concomitant severe liver, kidney or heart disease
7. Patients who are participating in or are scheduled to participate in other intervention studies
8. Patients who are pregnant or possibly pregnant, breastfeeding, or attempting pregnancy within 6 months after obtaining informed consent
9. Other patients whose investigators judged them inappropriate for participating in the mirogabalin intervention study
*: CLcr use the most recent serum-creatinine level in the 12 months prior to secondary enrollment
18age old over
No limit
Both
Type 2 diabetes mellitus
<How to administer research drugs>
For research subjects who are eligible for secondary enrollment, the prescription of the study drug will begin on the day of secondary enrollment. The dosage and method of administration of the research drug shall be in compliance with the electronic attachment. In principle, the titration method of research drugs is as follows in this study.
<Patients with CLcr of 60 mL/min or higher>
Mirogabalin 5 mg is prescribed twice daily during the first 2 weeks. Mirogabalin 10 mg will be prescribed twice daily for the next 2 weeks (within day22~36 for day15~Visit2 visit schedule). After the observation day of Visit2, the dose of mirogabalin 15 mg will be increased up to twice daily. The dosage may be adjusted from 10 mg to 15 mg at a time, twice daily according to the patient's age/condition.
<30 mL/min or less than 60 mL/min in CLcr>
Mirogabalin 2.5 mg is prescribed twice daily during the first 2 weeks. Mirogabalin 5 mg will be prescribed twice daily for the next 2 weeks (within day22~36 for day15~Visit2 visit schedule). After the observation day of Visit2, the dose of mirogabalin 7.5 mg will be increased up to twice daily. The dosage may be adjusted from 5 mg to 7.5 mg at a time, twice daily according to the patient's age/condition.
If mirogabalin is discontinued, follow the electronic attachment.
<Prohibited concomitant drugs>
Concomitant use of the following medicines is prohibited during the mirogabalin intervention study period:
1. Tricyclic antidepressant
2. Gabapentin, pregabalin, duloxetine, and mexiletine
3. Anticonvulsants
4. Opioid analgesic
5. Selective serotonin-reuptake inhibitors (SSRI).
6. Probenecid, cimetidine, lorazepam
<Prohibited concomitant therapy>
Concomitant use of the following therapies is prohibited during the mirogabalin intervention study period:
1. Spinal cord stimulation therapy
2. Pain-free therapies and surgical procedures that may influence the evaluation performed in this study
<Drugs for concomitant use/therapy>
1. Pain medications that have been in use since the beginning of the mirogabalin intervention study (Visit1) will not, in principle, change dosage and administration during the mirogabalin intervention study (Visit1~Visit3).
2. Combination therapy received for pain relief prior to the start of the mirogabalin intervention study (Visit1) will not, in principle, have changes in the frequency of implementation during the mirogabalin intervention study period (Visit1~Visit3).
<Mirogabalin Intervention Study>
1. Change in pain NRS from baseline (Visit1) at 12 weeks after initiation of mirogabalin
<Baseline survey>
1. Prevalence of DPN, prevalence of DPNP
2. Distributed pain NRS at DPNP check-up
3. Percentage of Subjective Symptoms by DPN Based on the Neuropathy Questionnaire
<Mirogabalin Intervention Study>
1. Change in pain NRS from baseline (Visit1) at 4 weeks after initiation of mirogabalin
2. Rate of 30% and 50% responders in pain NRS at 4 and 12 weeks after starting mirogabalin
3. Patient's impression of subjective symptoms
4. DPNP treatment satisfaction
5. PGIC*1 Distribution
6. Change in EQ-5D-5L*2 at Weeks 4 and 12 after initiation of mirogabalin
7. Change in sleep-disordered NRS *3 from baseline (Visit1) at 12 weeks after initiation of mirogabalin
8. Changes in the International-Standardized Physical Activity Questionnaire (IPAQ*4) at 4 and 12 weeks after initiation of mirogabalin.
*1: The Patient Global Impression of Change (change in general condition)
*2: EuroQol-5Dimention-5Level (Health-Related Quality-of-Life Quantitative Assessment Form)
*3: An index that evaluates the degree of sleep disturbance in 11 steps from 0 to 10
*4: International Physical Activity Questionnaire (International-Standardized Physical Activity Questionnaire).
