GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM

Durability of Early Initial Combination Therapy With Exenatide/Pioglitazone/Metformin vs Conventional Therapy in New Onset Type 2 Diabetes

Lead sponsor

The University of Texas Health Science Center at San Antonio

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

318

actual

Study population

Type 2 diabetes

Key I/E criterion

—

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 IDNCT01107717

Org study IDHSC20080456H

Secondary ID5R01DK103841-03

Timeline

Milestones

Study first posted2010-04-21estimated

Primary completion2023-02-03actual

Study completion2023-02-03actual

Last update posted2024-09-05actual

Results first posted2024-09-05actual

Study start2009-01 (month precision)

Assets

Investigational agents

Exenatide

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

•subjects with type 2 diabetes diagnosed during the past 2 years,

•above 18 years of age,

•drug naive, or have been on metformin less than 3 months

Exclusion criteria

•subjects with type 1 diabetes or GAD positive subjects or subjects with long standing diabetes (>2 years) or subjects who are not drug naive or have been on metformin more than 3 months.

Endpoints (3)

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.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

HbA1c Level

Time frame:at the end of the study (3 years)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of glycated hemoglobin	95% CI
Triple Therapy	6.9	—
Conventional Therapy	6.4	—

Secondary/protocol endpoint

Treatment Failure

Time frame:3 years

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), number of participants	95% CI
Triple Therapy	33	—
Conventional Therapy	59	—

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Percentage of Patients With Reported Hypoglycemic Events

Time frame:during the entire study (3 years)

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
Triple Therapy	14	—
Conventional Therapy	52	—

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Glycemic and non-glycemic benefits of initial triple therapy versus sequential add-on therapy in patients with new-onset diabetes: results from the EDICT study.
BMJ open diabetes research & care2025 Apr 27PMID40288809doi:10.1136/bmjdrc-2025-004981via clinicaltrials gov reference derived + pubmed nct search
Durability of Triple Combination Therapy Versus Stepwise Addition Therapy in Patients With New-Onset T2DM: 3-Year Follow-up of EDICT.
Diabetes care2021 Feb (month)PMID33273042doi:10.2337/dc20-0978via CT.gov reference + pubmed nct search

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.