DiabetesPhase 1NCT07436585
CGM-Guided Acarbose for Painful Diabetic Neuropathy
A Phase 1 study testing Acarbose 50 mg in people with Diabetes and Diabetes Complications, run by Shifa International Hospital at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Diabetes Complications, Diabetic Neuropathy
- What is being tested?
- Acarbose 50 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2025to 10 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Adults with T2D, painful DPN, and high CGM variability (e.g., MAGE >50 mg/dL on run-in) are randomized 1:1 to acarbose vs matching placebo for 4 weeks, on stable background analgesics. A standardized pharmacist-led algorithm escalates acarbose to target post-prandial spikes, guided by blinded CGM trend review. The primary endpoint is 4-week daily pain AUC captured via ePRO. Key secondary endpoints include changes in MAGE and time-in-range (TIR), skin microvascular reactivity (laser speckle), serum IL-6, patient global impression of change, rescue-analgesic use, and adverse events. Implementation outcomes (acceptability, feasibility, adoption, cost) are collected to inform scale-up in HIC and LMIC community settings.
- Conditions
- Diabetes, Diabetes Complications, Diabetic Neuropathy
- Being tested
- Acarbose 50 mg, Placebo
- Keywords
- Diabetic neuropathy, Pain, Acarbose
- Medical subject headings
- Diabetes Mellitus, Diabetes Complications, Diabetic Neuropathies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acarbose 50 mgDrug
Acarbose with meals; pharmacist-led titration (e.g., 50 mg TID → up to 100 mg TID as tolerated)
PlaceboDrug
Matching placebo; identical titration schedule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Acarbose 50 mg |
| Arm B | Placebo comparator | Matching placebo; identical titration schedule. Background analgesics held stable. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline→Week 4
CGM MAGE (mg/dL)
CGM MAGE (mg/dL)
Measured: baseline→Week 4
Secondary outcomes (4)
CGM Time-in-Range (70-180 mg/dL, %)
CGM Time-in-Range (70-180 mg/dL, %)
Measured: baseline→Week 4
Skin microvascular reactivity
Skin microvascular reactivity by laser speckle contrast imaging
Measured: baseline→Week 4
Serum IL-6
Serum IL-6 (pg/mL)
Measured: baseline→Week 4
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC). Patient Global Impression of Change (PGIC) assessed on a 7 point Likert scale ranging from 1 = very much improved to 7 = very much worse. Lower scores indicate improvement; higher scores indicate worsening.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shifa International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saima Abass Tahammal, Shifa International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436585
- Sponsor's protocol ID
- SH-34988983
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study, including the analyzable dataset and data dictionary, will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CGM-Guided Acarbose for Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT07436585
- Acronym / sponsor ID
- SH-34988983
- Conditions
- Diabetes, Diabetes Complications, Diabetic Neuropathy
- Keywords
- Diabetic neuropathy, Pain, Acarbose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Shifa International HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adults with T2D, painful DPN, and high CGM variability (e.g., MAGE >50 mg/dL on run-in) are randomized 1:1 to acarbose vs matching placebo for 4 weeks, on stable background analgesics. A standardized pharmacist-led algorithm escalates acarbose to target post-prandial spikes, guided by blinded CGM trend review. The primary endpoint is 4-week daily pain AUC captured via ePRO. Key secondary endpoints include changes in MAGE and time-in-range (TIR), skin microvascular reactivity (laser speckle), serum IL-6, patient global impression of change, rescue-analgesic use, and adverse events. Implementation outcomes (acceptability, feasibility, adoption, cost) are collected to inform scale-up in HIC and LMIC community settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Acarbose 50 mgAcarbose 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. |
| Arm B | Placebo comparator | Drug: PlaceboMatching placebo; identical titration schedule. Background analgesics held stable. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acarbose 50 mgAcarbose with meals; pharmacist-led titration (e.g., 50 mg TID → up to 100 mg TID as tolerated) | Drug | Arm A |
| PlaceboMatching placebo; identical titration schedule | Drug | Arm B |
Primary outcome
Daily pain AUC
Time frame: baseline→Week 4
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.
CGM MAGE (mg/dL)
Time frame: baseline→Week 4
CGM MAGE (mg/dL)
4 secondary outcomes
CGM Time-in-Range (70-180 mg/dL, %)
Time frame: baseline→Week 4
Skin microvascular reactivity
Time frame: baseline→Week 4
Serum IL-6
Time frame: baseline→Week 4
Patient Global Impression of Change (PGIC)
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study, including the analyzable dataset and data dictionary, will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acarbose 50 mg in people with Diabetes and Diabetes Complications, run by Shifa International Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily pain AUC (time frame: baseline→Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.