Dia-NeP study (Dia-NeP study)

Recruiting

• Conditions: Type 2 diabetes mellitus

• Registration Number: jRCTs031240623

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Study Start: 2025-03-31
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

<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 survey1 and having a pain NRS3 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

<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

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
Change in pain NRS from baseline	12 weeks after initiation of mirogabalin	Change in pain NRS from baseline (Visit1) at 12 weeks after initiation of mirogabalin

Secondary Outcome Measures

Name	Time	Method
PGIC Distribution		The Patient Global Impression of Change (change in general condition)
Change in EQ-5D-5L at Weeks 4 and 12 after initiation of mirogabalin	Weeks 4 and 12 after initiation of mirogabalin	EuroQol-5Dimention-5Level (Health-Related Quality-of-Life Quantitative Assessment Form)
Change in sleep-disordered NRS from baseline (Visit1) at 12 weeks after initiation of mirogabalin	12 weeks after initiation of mirogabalin	An index that evaluates the degree of sleep disturbance in 11 steps from 0 to 10
Changes in the International-Standardized Physical Activity Questionnaire (IPAQ) at 4 and 12 weeks after initiation of mirogabalin	4 and 12 weeks after initiation of mirogabalin	International Physical Activity Questionnaire (International-Standardized Physical Activity Questionnaire)