TerminatedPhase 3

Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Lead sponsor

Intarcia Therapeutics

Asset

Exenatide

GLP-1 agonist

Listed sites

101

Recruiting sites

Actual enrollment

245

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 25-45•HbA1c 7.5-10.5%

Primary endpoints

•HbA1c, change•Weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03060980

Org study IDITCA 650-CLP-203

Timeline

Milestones

Study first posted2017-02-23actual

Study start2017-03-03actual

Primary completion2018-01-26actual

Study completion2018-01-26actual

Last update posted2019-03-07actual

Assets

Investigational agents

Exenatide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of T2D 3 months prior to the Screening Visit.

•Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.

•Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).

Exclusion criteria

•History of type 1 diabetes.

•Prior participation in a clinical study involving ITCA 650.

•Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening.

•History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.

•History or evidence of acute or chronic pancreatitis.

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

•Treatment of medications that affect GI motility.

•History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients.

•Women that are pregnant, lactating, or planning to become pregnant.

•Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.

Endpoints (2)

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

Weight & body composition

Glycemic / diabetes

Weight & body composition

1 endpoint

Primary/protocol endpoint

Reduction in weight

Time frame:Randomization to 69 weeks

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Reduction in glycosylated hemoglobin A1c

Time frame:Randomization to 69 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.