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Clinical Trial NCT07241897 for Ischemic Stroke, Diabete Mellitus is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes Phase 3 312 Randomized Double-Blind Placebo-Controlled
Clinical Trial NCT07241897 is designed to study Treatment for Ischemic Stroke, Diabete Mellitus. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on December 15, 2025 until the study accrues 312 participants. Led by Second Affiliated Hospital of Soochow University, this study is expected to complete by April 30, 2028. The latest data from ClinicalTrials.gov was last updated on November 21, 2025.
Brief Summary
Post-stroke cognitive impairment (PSCI) increases the risk of disability and mortality in stroke patients, thereby exacerbating the disease burden of stroke. Type 2 diabetes is a major risk factor for PSCI, and stroke patients with type 2 diabetes have a higher risk of developing PSCI. Despite the high incidence and severe impact of PSCI, effective intervention methods are still lacking. Identifying safe and effectiv...Show More
Official Title
DPP4 Inhibitor on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes Mellitus (DISC-DM): Multicentre, Double Blind, Randomised, Placebo Controlled Trial
Conditions
Ischemic StrokeDiabete MellitusPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- LC2024019
- 82471226 (Other Grant/Funding Number) (the National Natural Science Foundation of China)
NCT ID Number
Start Date (Actual)
2025-12-15
Last Update Posted
2025-11-21
Completion Date (Estimated)
2028-04-30
Enrollment (Estimated)
312
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
DPP4 inhibitors
Ischemic Stroke
PSCI
Diabetes Mellitus
RCT
Ischemic Stroke
PSCI
Diabetes Mellitus
RCT
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIntervention Group Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. | Sentagliptin Phosphate - single dose Sentagliptin Phosphate 50 mg, once daily, plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. |
Placebo ComparatorControl Group Placebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed | Placebo Placebo (identical in size, shape, color, appearance, and odor to Sentagliptin Phosphate, 50 mg, once daily) plus metformin hydrochloride extended-release tablets (50 mg, two or three times daily). If blood glucose is still not well-controlled, sulfonylurea drugs may be added as needed. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in MoCA score before and after the 180-day intervention | Change in MoCA score before and after the 180-day intervention | 180 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
PSCI incidence at 180 days | MoCA score \< 25 | 180 days |
Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention | Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention | 180 days |
Changes in MoCA and MMSE scores before and after the 90-day intervention | Changes in MoCA and MMSE scores before and after the 90-day intervention | 90 days |
Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days | Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days | 90 days and 180 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
40 Years
Eligible Sexes
All
- Mild ischemic stroke, defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.
- Coexisting type 2 diabetes with a disease duration of less than 5 years.
- Ability to complete the MoCA, MMSE, and the NINDS-CSN-recommended 1-hour standardized neuropsychological test for VCI.
- Age between 40 and 75 years.
- Onset of stroke within the last 2 weeks.
- Glycated hemoglobin (HbA1c) between 6.5% and 8.5%.
- More than 9 years of education.
- Informed consent signed by the patient or their family.
- Coexisting dementia or severe cognitive impairment (MoCA < 17).
- Coexisting severe depression, defined as a Hamilton Depression Rating Scale (HAMD) score ≥ 20.
- Prior use of cognitive-enhancing drugs, such as donepezil or memantine.
- Allergy to DPP4 inhibitors.
- Past or current use of DPP4 inhibitors.
- Past or current use of GLP-1 agonists.
- Type 1 diabetes, latent autoimmune diabetes in adults, secondary diabetes, malignant tumors, autoimmune diseases, or other endocrine-related diseases.
- Moderate or severe liver or kidney dysfunction.
- Chronic or acute pancreatitis.
- Pregnancy or lactation.
- Severe infection or severely impaired immune response.
- Participation in other clinical trials.
- Past or current use of insulin therapy.
Second Affiliated Hospital of Soochow UniversityStudy Responsible Party
yifang zhu, Principal Investigator, Professor, Second Affiliated Hospital of Soochow University
Study Central Contact
Contact: Shoujiang You, MD, PhD, +8615995738506, [email protected]
Contact: WenYan Hua, MD, 0512-67783682, [email protected]
1 Study Locations in 1 Countries
Jiangsu
Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215004, China
Shoujiang You, MD, PhD, Contact, 00 86 512 67783662, [email protected]
Yongjun Cao, MD, PhD, Contact, 00 86 512 67784789, [email protected]