CGM-Guided Acarbose for Painful Diabetic Neuropathy

NCT07436585 | Completed Phase 1

• 1 other identifier: SH-34988983
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II pragmatic hybrid effectiveness-implementation trial tests whether acarbose, titrated using continuous glucose monitoring (CGM) to blunt post-prandial excursions, reduces 4-week pain area-under-the-curve (AUC) versus placebo in adults with painful diabetic peripheral neuropathy (DPN) and high glycemic variability. Secondary objectives assess CGM variability metrics, microvascular reactivity, inflammatory markers, safety, and feasibility of a pharmacist-led titration workflow using loaner CGMs across multi-region community clinics.

Conditions

Diabetes Complications; Diabetic Neuropathy; Diabetes

Keywords

Diabetic neuropathy; Pain; Acarbose

Outcome Measures

Primary Outcomes (2)

• Daily pain AUC

  Daily pain AUC (ePRO; 0-10 NRS). Method: trapezoidal AUC of daily NRS scores; higher AUC = worse pain. Daily pain area under the curve derived from the Numeric Rating Scale for Pain (NRS). The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. AUC is calculated using the trapezoidal method from daily NRS scores over the assessment period. Higher AUC values indicate greater overall pain burden.

  baseline→Week 4

• CGM MAGE (mg/dL)

  CGM MAGE (mg/dL)

  baseline→Week 4

Secondary Outcomes (4)

• CGM Time-in-Range (70-180 mg/dL, %)

  baseline→Week 4

• Skin microvascular reactivity

  baseline→Week 4

• Serum IL-6

  baseline→Week 4

• Patient Global Impression of Change (PGIC)

  Week 4

Study Arms (2)

Arm A

EXPERIMENTAL

Acarbose with meals; pharmacist-led titration (e.g., 50 mg TID → up to 100 mg TID as tolerated) to curb post-prandial excursions based on CGM review. Background analgesics held stable.

Drug: Acarbose 50 mg

Arm B

PLACEBO COMPARATOR

Matching placebo; identical titration schedule. Background analgesics held stable.

Drug: Placebo

Interventions

Acarbose 50 mg DRUG

Acarbose with meals; pharmacist-led titration (e.g., 50 mg TID → up to 100 mg TID as tolerated)

Arm A

Placebo DRUG

Matching placebo; identical titration schedule

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Type 2 diabetes ≥1 year; HbA1c 7.0-10.0% within 8 weeks of randomization.
• Painful DPN meeting clinical criteria; average daily pain NRS ≥4 during run-in.
• High CGM variability on 7-10 day run-in (e.g., MAGE \>50 mg/dL).
• Stable analgesic regimen ≥4 weeks pre-baseline.
• Able to use CGM and ePRO; provides informed consent.

You may not qualify if:

• Type 1 diabetes; non-diabetic neuropathies.
• Contraindications to acarbose (e.g., chronic intestinal malabsorption, inflammatory bowel disease).
• eGFR \<45 mL/min/1.73 m²; significant hepatic disease (ALT/AST \>3× ULN).
• Use of α-glucosidase inhibitors within 3 months.
• Recent change (\<3 months) in GLP-1/GIP agonists, SGLT2i, or basal/bolus insulin strategy.
• Pregnancy/lactation; other conditions compromising safety/assessments.

Sponsors & Collaborators

• Shifa International Hospital: lead

Study Sites (1)

Shifa International hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Complications; Diabetic Neuropathies; Pain

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 10, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication and for up to 5 years.
• Access Criteria: Data will be made available to qualified researchers upon reasonable request following publication of the primary results. Requests must include a scientifically sound proposal and statistical analysis plan. Access will require approval by the sponsor and execution of a data use agreement.

Locations

PA (1)