GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 3

A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c

Lead sponsor

Intarcia Therapeutics

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

100

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 10-12%

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 IDNCT01785771

Org study IDITCA 650-CLP-103-Sub-Study

Timeline

Milestones

Study first posted2013-02-07estimated

Last update posted2019-03-07actual

Study start2013-05 (month precision)

Primary completion2018-01actual (month precision)

Study completion2018-01actual (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

•Men or women age 18 to 80 years with type 2 diabetes

•On stable treatment regimen of diet and exercise alone or in combination with a stable \& optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs

•HbA1c >10.0% and ≤12.0%

Exclusion criteria

•Prior treatment with any GLP-1 receptor agonist

•History of hypersensitivity to exenatide or liraglutide

•FPG >300 mg/dL

•History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2

•Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months

•history of pancreatitis

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 Week 39 and Day 0

Time frame:39 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Publications (1)

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

Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA(1c): The FREEDOM-1 HBL (High Baseline) Study.
Diabetes care2018 Mar (month)PMID29301824doi:10.2337/dc17-1519via clinicaltrials gov reference derived + 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 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.