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DIRECTGLP

CompletedPhase NA

DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists

Lead sponsor

University of Dundee

Assets

Exenatide / GLP-1 / incretin class catch-all / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

411

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7.5%

Primary endpoint

•HbA1c, change

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 IDNCT01575301

Org study ID2011DIRECT01 (GLP)

Timeline

Milestones

Study first posted2012-04-11estimated

Study completion2015-12-11actual

Last update posted2018-04-11actual

Study start2011-03 (month precision)

Primary completion2015-07actual (month precision)

Assets

Investigational agents

Exenatide GLP-1 / incretin class catch-all Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with Type 2 diabetes where a clinical decision has been made to commence a GLP-1R agonist

•Either:

1. On any combination of oral hypoglycaemic agents

2. On Insulin (+/- oral hypoglycaemic agents)

•HbA1c ≥7.5% (58mmol/mol) and HbA1c < 12% (108mmol/mol)

•White European

•Age ≥ 18 and < 80

Exclusion criteria

•Type 1 diabetes

•HbA1c <7.5% (58 mmol/mol)

•HbA1c ≥ 12% (108 mmol/mol)

•Pregnancy or lactation

•Any other significant medical reason for exclusion as determined by the investigator

•Inability to consent

•Participating in a CTIMP during the study period and within 30 days prior to study start.

Endpoints (1)

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.

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Change in HbA1c between baseline and 6 months

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.