Loading clinical trials...

A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

NCT01785771•Intarcia Therapeutics

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 80 years

Sex

ALL

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

Locations (51)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

Fundamental Research

Gulf Shores, Alabama, United States

East Valley Family Physicians, PLC

Chandler, Arizona, United States

Desert Clinical Research

Mesa, Arizona, United States

Clinical Research Advantage, Inc.

Phoenix, Arizona, United States

eStudySite

Chula Vista, California, United States

Rocks Medical Research Institute, Inc.

Fresno, California, United States

Rocks Medical Research Institute

Fresno, California, United States

Long Beach Center for Clinical Research

Long Beach, California, United States

Saviers Medical Group

Port Hueneme, California, United States

Key Dates

Start Date

May 1, 2013

Primary Completion Date

January 1, 2018

Completion Date

January 1, 2018

Last Updated

March 7, 2019

Enrollment

100

ESTIMATED participants

Conditions

Type 2 Diabetes

Interventions

ITCA 650 (exenatide in DUROS)

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

Closed-loop in Adults With Type 2 Diabetes

SGLT2i, Pioglitazone, and Ketone Production in T2D