NCT07244770

Brief Summary

The study aims to investigate the effects of DPP-4 Is+ metformin versus SGLT2 Is + metformin on the risk of cognitive decline and depression in patients with T2DM.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 1, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 9, 2025

Last Update Submit

January 28, 2026

Conditions

MCI

Outcome Measures

Primary Outcomes (2)

  • MCI

    Changes in Montreal Cognitive Assessment (MoCA) score

    Day 1

  • Depression

    Changes in Patient Health Questionnaire-9 (PHQ-9) score

    Day 1

Study Arms (3)

SGLT2 I Group

T2DM patients given SGLT2 Is + metformin added to standard of care

Drug: SGLT2 Is+METFORMIN

DPP4I group

T2DM patients given DPP4Is + metformin added to standard of care

Drug: DPP4 Is+metformin

Control group

T2DM patients given conventional therapy only

Drug: Control group

Interventions

SGLT2 Is+METFORMINDRUG

Patients administering SGLT2 Is+metformin added to their treatment for at least the past 12 months

Also known as: Group 1
SGLT2 I Group
DPP4 Is+metforminDRUG

Patients administering DPP4 I+ metformin added to their treatment for at least the past 12 months

Also known as: Group 2
DPP4I group
Control groupDRUG

patients administered their standard of care without any changes for the past 6 months

Also known as: Group 3
Control group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

T2DM patients (aged above 55 years)

You may qualify if:

  • T2DM adult subjects (\>55 years old) will be eligible to participate.
  • Patients should be taking SGLT2Is+metformin or DDP4Is + metformin for at least 1 year to be eligible.

You may not qualify if:

  • Those with type1 diabetes or ketoacidosis, insulin therapy, end organ failure as chronic renal failure, liver, and heart failure, previous history of pancreatitis, history of Alzheimer's disease or any brain insult, and finally pregnant or lactating females will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni Suef Hospital

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Asmaa Abdelfattah

CONTACT

002-01095727201asmaa_abdelfattah86@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of clinical pharmacy

Study Record Dates

First Submitted

January 9, 2025

First Posted

November 24, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

EG(1)