GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT00943917

CompletedPhase 2Results posted

Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Intarcia Therapeutics

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

155

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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 IDNCT00943917

Org study IDITCA 650-CLP-02

Timeline

Milestones

Study first posted2009-07-22estimated

Results first posted2012-05-03estimated

Last update posted2015-04-13estimated

Study start2009-08 (month precision)

Primary completion2010-08actual (month precision)

Study completion2011-02actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Males or females age 18-70 years

•Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1

•On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;

•Fasting plasma glucose < 240 mg/dL at Screening Visit 1

•HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

Exclusion criteria

•Prior treatment with exenatide

•Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)

•History of type 1 diabetes and/or history of diabetic ketoacidosis

•Body mass index ≥ 40 kg/m2;

•History of organ transplantation

Endpoints (6)

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

6 endpoints

Primary/protocol endpoint

Mean Change in HbA1c (Per Protocol)

Time frame:Day 0 and Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent change	95% CI
ITCA 650 20 mcg/Day - STAGE I	-0.96	—
ITCA 650 40 mcg/Day - STAGE I	-1.04	—
Exenatide Injection - STAGE I	-0.82	—

Primary/protocol endpoint

Mean Change in HbA1c (ITT)

Time frame:Day 0 to Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent change	95% CI
ITCA 650 20 mcg/Day - STAGE I	-.93	—
ITCA 650 40 mcg/Day - STAGE I	-0.96	—
Exenatide Injection - STAGE I	-0.75	—

Primary/protocol endpoint

Mean Change in HbA1c (Per Protocol)

Time frame:Day 0 to Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent change	95% CI
ITCA 650 20/20	-.89	—
ITCA 650 20/60	-1.26	—
ITCA 650 40/40	-0.67	—
ITCA 650 40/80	-1.36	—
Ex Inj/ITCA 650 40	-1.01	—
Ex Inj/ITCA 650 60	-1.51	—

Primary/protocol endpoint

Mean Change in HbA1c (ITT)

Time frame:Day 0 to Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent change	95% CI
ITCA 650 20/20	-0.89	—
ITCA 650 20/60	-1.26	—
ITCA 650 40/40	-0.70	—
ITCA 650 40/80	-1.36	—
Ex Inj/ITCA 650 40	-1.01	—
Ex Inj/ITCA 650 60	-1.51	—

Primary/protocol endpoint

Mean Change in HbA1c (Per Protocol)

Time frame:Day 0 to Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent change	95% CI
ITCA 650 20/20	-1.00	—
ITCA 650 20/60	-1.23	—
ITCA 650 40/40	-0.69	—
ITCA 650 40/80	-1.37	—
Ex Inj/ITCA 650 40	-1.45	—
Ex Inj/ITCA 650 60	-1.88	—

Primary/protocol endpoint

Mean Change in HbA1c (ITT)

Time frame:Day 0 to Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percent change	95% CI
ITCA 650 20/20	-1.13	—
ITCA 650 20/60	-1.25	—
ITCA 650 40/40	-0.48	—
ITCA 650 40/80	-1.40	—
Ex Inj/ITCA 650 40	-1.16	—
Ex Inj/ITCA 650 60	-1.84	—

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

Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes.
Diabetes care2013 Sep (month)PMID23645886doi:10.2337/dc12-2410via 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.