CGM-Guided Acarbose Titration to Reduce Short-Term Pain Flares in Painful Diabetic Peripheral Neuropathy

CGM-Guided Acarbose Titration to Reduce Short-Term Pain Flares in Painful Diabetic Peripheral Neuropathy - GLIDE-DPN

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059433

Enrollment

175

Registered

2025-12-09

Start date

2025-10-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painful diabetic peripheral neuropathy (DPN) in adults with type 2 diabetes and high glycemic variability

Interventions

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. Matching placebo t

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Type 1 diabetes or non-diabetic neuropathies Contraindication to acarbose (for example chronic intestinal malabsorption, inflammatory bowel disease, bowel obstruction) eGFR < 45 mL/min/1.73 m2 or ALT/AST > 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

Design outcomes

Primary

Measure	Time frame
Daily pain AUC (0-10 NRS, ePRO). Time frame: Weeks 0-4. Definition: trapezoidal AUC of once-daily pain scores (higher AUC = worse pain).	—

Secondary

Measure	Time frame
CGM MAGE (mg/dL), baseline to week 4. Time-in-range 70-180 mg/dL (%), baseline to week 4. GV responder rate at week 4 (>=10 mg/dL MAGE reduction or >=5% absolute TIR increase). Skin microvascular reactivity by laser speckle, baseline to week 4. Serum IL-6 (pg/mL), baseline to week 4. PGIC at week 4. Rescue-analgesic use (DDD per week), weeks 0-4. Adverse events, weeks 0-6. Feasibility and acceptability metrics, weeks 0-4. Adherence to study drug, weeks 0-4.	—

Measure

Time frame

CGM MAGE (mg/dL), baseline to week 4. Time-in-range 70-180 mg/dL (%), baseline to week 4. GV responder rate at week 4 (>=10 mg/dL MAGE reduction or >=5% absolute TIR increase). Skin microvascular reactivity by laser speckle, baseline to week 4. Serum IL-6 (pg/mL), baseline to week 4. PGIC at week 4. Rescue-analgesic use (DDD per week), weeks 0-4. Adverse events, weeks 0-6. Feasibility and acceptability metrics, weeks 0-4. Adherence to study drug, weeks 0-4.

—

Countries

Asia(except Japan)

Contacts

Public ContactSaima Abbass

Shifa International Hospital Medical director office

saimaabasstahammal@gmail.com00923206503200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026