Tokyo, Dec. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059433) titled 'CGM-Guided Acarbose Titration to Reduce Short-Term Pain Flares in Painful Diabetic Peripheral Neuropathy' on Dec. 9.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Shifa International hospital

Condition: Condition - Painful diabetic peripheral neuropathy (DPN) in adults with type 2 diabetes and high glycemic variability Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To determine whether CGM-guided acarbose titration reduces 4-week daily pain AUC versus placebo in adults with painful DPN and high glycemic variability. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Oral acarbose with main meals for 4 weeks. Start 50 mg three times daily; uptitrate weekly by 50 mg per meal as tolerated to 100 mg three times daily. Goal: blunt post-prandial excursions guided by masked CGM review. Background analgesics kept stable. Interventions/Control_2 - Matching placebo tablets with main meals for 4 weeks. Sham uptitration aligned to acarbose schedule (50 mg-equivalent TID to 100 mg-equivalent TID). Background analgesics kept stable.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Age 18 to 75 years

Type 2 diabetes for at least 1 year

Painful diabetic peripheral neuropathy meeting clinical criteria

Average daily pain NRS >= 4 during run-in

High glycemic variability on masked CGM run-in (for example MAGE > 50 mg/dL over 7 to 10 days)

HbA1c 7.0 to 10.0 percent within 8 weeks before randomization

Stable analgesic regimen for at least 4 weeks before baseline

Able and willing to use CGM and ePRO and to give informed consent Key exclusion criteria - Type 1 diabetes or non-diabetic neuropathies

Contraindication to acarbose (for example chronic intestinal malabsorption, inflammatory bowel disease, bowel obstruction)

eGFR 3 x upper limit of normal

Use of alpha-glucosidase inhibitors within 3 months

Major change in GLP-1 or GIP receptor agonists, SGLT2 inhibitor, or insulin strategy within 3 months

Pregnant or lactating, or planning pregnancy during the study

Any condition that, in the opinion of investigators, would compromise safety, adherence, or outcome assessments Target Size - 175

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 08 Month 20 Day Date of IRB - 2025 Year 08 Month 28 Day Anticipated trial start date - 2025 Year 10 Month 18 Day Last follow-up date - 2025 Year 11 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067964

Disclaimer: Curated by HT Syndication.