GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Intarcia Therapeutics

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥6.5%

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT01798264

Org study IDITCA 650-CLP-01

Timeline

Milestones

Study first posted2013-02-25estimated

Last update posted2013-05-17estimated

Results first posted2013-05-17estimated

Study start2009-02 (month precision)

Primary completion2009-05actual (month precision)

Study completion2009-05actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•type 2 diabetes >6 months

•stable diet \& exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%

Exclusion criteria

•prior treatment with exenatide

•history of pancreatitis

•history of medullary thyroid cancer or multiple endocrine neoplasia 2

Endpoints (4)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in Weight From Baseline to 4 Weeks

Time frame:4 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
10 Mcg/Day	-0.3	—
20 Mcg/Day	-0.3	—
40 Mcg/Day	-1.1	—
80 Mcg/Day	-3.1	—

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Time frame:4 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage	95% CI
10 Mcg/Day	-0.5	—
20 Mcg/Day	-0.6	—
40 Mcg/Day	-0.5	—
80 Mcg/Day	-0.7	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline

Time frame:4 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
10 Mcg/Day	-5.6	—
20 Mcg/Day	-31.2	—
40 Mcg/Day	-42.0	—
80 Mcg/Day	-28.8	—

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Number of Subjects With Study Drug-Related Adverse Events

Time frame:4 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), participants	95% CI
10 Mcg/Day	9	—
20 Mcg/Day	11	—
40 Mcg/Day	9	—
80 Mcg/Day	11	—

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

A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes.
Clinical therapeutics2013 May (month)PMID23578605doi:10.1016/j.clinthera.2013.03.011via 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 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.