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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01785771

Enrollment

100

Registered

2013-02-07

Start date

2013-05-31

Completion date

2018-01-31

Last updated

2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c \>10% \</=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day

Interventions

DRUGITCA 650 (exenatide in DUROS)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c between Week 39 and Day 0	39 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026