Type 2 diabetes mellitus
Conditions
Interventions
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 resear
Sponsors
Kamiya Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 1. Patients who are judged by the investigator to be inappropriate as research subjects 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in pain NRS from baseline (Visit1) at 12 weeks after initiation of mirogabalin | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 1. Association between DPNP diagnosis and simplified diagnostic criteria for DPN 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 from baseline (Visit1) 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) from baseline (Visit1) 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). | — |
Contacts
Public ContactHideki Kamiya
Aichi Medical University Hospital
Outcome results
None listed