UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059433 |
|---|---|
| Receipt number | R000067964 |
| Scientific Title | CGM-Guided Acarbose Titration to Reduce Short-Term Pain Flares in Painful Diabetic Peripheral Neuropathy |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/10/16 16:43:11 |
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Basic information
Public title
CGM-Guided Acarbose Titration to Reduce Short-Term Pain Flares in Painful Diabetic Peripheral Neuropathy
Acronym
GLIDE-DPN
Scientific Title
CGM-Guided Acarbose Titration to Reduce Short-Term Pain Flares in Painful Diabetic Peripheral Neuropathy
Scientific Title:Acronym
GLIDE-DPN
Region
| Asia(except Japan) |
Condition
Condition
Painful diabetic peripheral neuropathy (DPN) in adults with type 2 diabetes and high glycemic variability
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Daily pain AUC (0-10 NRS, ePRO). Time frame: Weeks 0-4. Definition: trapezoidal AUC of once-daily pain scores (higher AUC = worse pain).
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | 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 < 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
Target sample size
175
Research contact person
Name of lead principal investigator
| 1st name | Nadia |
| Middle name | |
| Last name | Hussain |
Organization
Al Ain University
Division name
College of Pharmacy
Zip code
64141
Address
Al Ain
TEL
05054407153
nadia.hussain@aau.ac.ae
Public contact
Name of contact person
| 1st name | Saima |
| Middle name | |
| Last name | Abbass |
Organization
Shifa International Hospital
Division name
Medical director office
Zip code
Chak 50
Address
Nankana
TEL
00923206503200
Homepage URL
saimaabasstahammal@gmail.com
Sponsor or person
Institute
Shifa International hospital
Institute
Department
Personal name
Saima Abbass
Funding Source
Organization
Shifa International Hospital
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Pakistan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shifa International hospital
Address
Chak 50, Nankana, Sheikhupura
Tel
00923206503200
saimaabasstahammal@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
SH-34988983
Org. issuing International ID_1
Shifa International hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Shifa International hospital
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
160
Results
Recruitment is ongoing. No study results are available at this time. The primary completion is not yet reached.
Results date posted
| 2025 | Year | 10 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Enrollment and baseline assessments are in progress. Aggregate baseline data will be posted after a prespecified lock of the first N participants. Variables to be summarized include: age, sex, diabetes duration, HbA1c, baseline pain NRS, MAGE (mg/dL), time-in-range 70-180 mg/dL (%), eGFR, and concomitant analgesic class.
Participant flow
Screened to date = [S]
Excluded = [E] (not meeting criteria = [E1]; declined = [E2]; other = [E3])
Randomized = [R]
Allocated to acarbose = [R1] (received intervention = [RI1]; did not receive = [DNI1] [reason])
Allocated to placebo = [R2] (received intervention = [RI2]; did not receive = [DNI2] [reason])
Completed week 4 = [C1_acarbose] / [C1_placebo]
Analyzed for primary endpoint = [A1_acarbose] / [A1_placebo]
Adverse events
Safety monitoring is ongoing. Interim summaries will be posted after the first scheduled safety review. No aggregate AE results are available at this time.
Outcome measures
Primary outcome daily pain AUC, weeks 0 to completion
Plan to share IPD
Yes
IPD sharing Plan description
De-identified individual participant data (IPD), data dictionary, and statistical analysis code will be shared. Data will be available beginning 12 months after the primary publication and for at least 5 years. Access will be provided via a public repository (for example Zenodo or Dryad) under a data use agreement for non-commercial research. Requests will be reviewed by the sponsor-investigator team to ensure scientific merit and privacy protections. Documents to be shared include protocol, SAP, and CONSORT checklist.
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067964
