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NCT Number: NCT07241897

DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes

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 effective drugs to improve cognitive function in stroke patients and reduce the risk of PSCI, especially for those with type 2 diabetes, is of significant importance and could help reduce the burden of stroke.

Dipeptidyl peptidase-4 (DPP4) inhibitors are first-line antidiabetic drugs, and several studies have shown that DPP4 inhibitors provide benefits beyond glucose control, including significantly improving cognitive function in patients with type 2 diabetes or slowing the progression of cognitive impairment. Our previous research found a significant negative correlation between baseline plasma soluble DPP4 (sDPP4) levels and the 90-day PSCI risk in ischemic stroke patients. Moreover, some studies indicate that DPP4 inhibitors can increase plasma sDPP4 levels. Based on this, we hypothesize that DPP4 inhibitors could be effective for PSCI intervention and may improve cognitive function post-stroke.

This project aims to conduct a multicenter, randomized, double-blind, placebo-controlled study. We will include patients with mild ischemic stroke combined with type 2 diabetes and provide continuous intervention with DPP4 inhibitors or a placebo for 180 days. Cognitive function in both groups will be assessed before and after intervention to determine if DPP4 inhibitors can improve cognitive function and reduce the risk of PSCI in ischemic stroke patients with type 2 diabetes. Clinical blood samples and imaging data will also be used to preliminarily explore potential mechanisms.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Stroke Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Sentagliptin Phosphate - single dose

Drug

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

Drug

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 outcomes

  1. Change in MoCA score before and after the 180-day intervention

    Time frame: 180 days

    Change in MoCA score before and after the 180-day intervention

Secondary outcomes

  1. PSCI incidence at 180 days

    Time frame: 180 days

    MoCA score < 25

  2. Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention

    Time frame: 180 days

    Changes in MMSE score and scores in various cognitive domains before and after the 180-day intervention

  3. Changes in MoCA and MMSE scores before and after the 90-day intervention

    Time frame: 90 days

    Changes in MoCA and MMSE scores before and after the 90-day intervention

  4. Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days

    Time frame: 90 days and 180 days

    Modified Rankin Scale (mRS) score and cardiovascular and cerebrovascular events at 90 and 180 days

Study contacts

Contact information is provided by the study sponsor or research team.

Shoujiang You, MD, PhD

CONTACT

[email protected]

+8615995738506

WenYan Hua, MD

CONTACT

[email protected]

0512-67783682

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Soochow University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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