← Trials/Trial dossier/NCT05768945

CompletedResults posted

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

742,670

actual

Study population

Type 2 diabetes

Key I/E criterion

Age ≥65

Primary endpoint

Dementia Onset

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05768945
Org study ID2019P003607-14

Timeline

Milestones

Study start2022-11-30actual
Study first posted2023-03-15actual
Primary completion2023-07-07actual
Study completion2023-12-31actual
Last update posted2025-11-10actual
Results first posted2025-11-10actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age65 Years
SexAll
Healthy volunteersAccepted
Sampling methodNon probability sample

Study population text

This study will employ a new user, active comparator, observational cohort study design comparing semaglutide v DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin). The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).

Inclusion criteria

Please see https://drive.google.com/drive/folders/1VRjPaaelXFyBbA5gV6pwB_ijSIMyIJ4N?usp=share_link or Appendix A(https://drive.google.com/drive/folders/1OgKQlxsJi9UWRDd3Kbaux_8adngoSnZY?usp=sharing) for full code and algorithm definitions.

Medicare timeframe: 2008 to 2019 (end of data availability).

Inclusion Criteria:

1. Aged >/= 65 years on the index date
2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
3. Diagnosis code for type 2 diabetes measured 365 days prior to drug initiation

Exclusion criteria

1. Prior history of dementia measured anytime prior to cohort entry date
2. Prior history of nursing home admission in the 365 days prior to the cohort entry date
3. Prior use of any GLP receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or DPP4 inhibitors
4. Prior use of Semaglutide or DPP4 inhibitors concomitantly on index date

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

2 endpoints
Primary/registry result

Time to Dementia Onset

Time frame:Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 days (ref)

time to event, event

Posted result

GroupValue (number), Incidence rate per 1000 person year95% CI
SemaglutideAnalysis 14.402.27 – 7.68
Analysis 24.691.28 – 12.02
Analysis 32.800.34 – 10.13
Analysis 40.370.01 – 2.04
DPP4 InhibitorsAnalysis 16.063.70 – 9.36
Analysis 26.712.70 – 13.83
Analysis 310.246.96 – 14.54
Analysis 40.610.07 – 2.19
Primary/protocol endpoint

Time to Dementia Onset

Time frame:Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 days (ref)

time to event, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.