Clinical trial NCT01785771: A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c between Week 39 and Day 0
timeFrame: 39 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Gulf Shores
country: United States
facility: Fundamental Research
state: Alabama
city: Chandler
country: United States
facility: East Valley Family Physicians, PLC
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Fresno
country: United States
facility: Rocks Medical Research Institute, Inc.
state: California
city: Fresno
country: United States
facility: Rocks Medical Research Institute
state: California
city: Long Beach
country: United States
facility: Long Beach Center for Clinical Research
state: California
city: Port Hueneme
country: United States
facility: Saviers Medical Group
state: California
city: Tustin
country: United States
facility: University Clinical Investigatons, Inc/Diabetes Research Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Health Partners-Briargate
state: Colorado
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: International Research Assocaites, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research, Inc.
state: Florida
city: Palm Harbor
country: United States
facility: Palm Harbor Medical Associates
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron, D.O., P.A.
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Atlanta
country: United States
facility: Perimeter Institute for Clinical Research PRIME
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Avon
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC
state: Indiana
city: Franklin
country: United States
facility: American Health Network of Indiana
state: Indiana
city: Muncie
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Valparaiso
country: United States
facility: Bunyan Clinical Research
state: Indiana
city: Metairie
country: United States
facility: Crescent City Clinical Research Center
state: Louisiana
city: Las Vegas
country: United States
facility: Palm Research Center, Inc.
state: Nevada
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Durham
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services, LLC
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Memphis
country: United States
facility: BMG The Endocrine Clinic
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Corpus Christi
country: United States
facility: 3rd Coast Research Associates
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Galena Research
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Medstar Clinical Research and Associates
state: Texas
city: San Angelo
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Port Orchard
country: United States
facility: Sound Healthcare
state: Washington
city: Renton
country: United States
facility: Ranier Clinical Research Center
state: Washington
Study officials:
References:
citation: Henry RR, Rosenstock J, Denham DS, Prabhakar P, Kjems L, Baron MA. Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA1c: The FREEDOM-1 HBL (High Baseline) Study. Diabetes Care. 2018 Mar;41(3):613-619. doi: 10.2337/dc17-1519. Epub 2018 Jan 4.