Clinical trial NCT01455857: A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* HbA1c between 7.5% - 10%
* On diet \& exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
* BMI between 25 \& 45 kg/m2

Exclusion Criteria:

* taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
* history of pancreatitis

Primary outcomes:
measure: Change in HbA1c
timeFrame: 39 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Study Site
state: Alabama
city: Gulf Shores
country: United States
facility: Study Site
state: Alabama
city: Huntsville
country: United States
facility: Study Site
state: Alabama
city: Chandler
country: United States
facility: Study Site
state: Arizona
city: Goodyear
country: United States
facility: Study Site
state: Arizona
city: Phoenix
country: United States
facility: Study Site
state: Arizona
city: Little Rock
country: United States
facility: Study Site
state: Arkansas
city: Chula Vista
country: United States
facility: Study Site
state: California
city: Fresno
country: United States
facility: Study Site
state: California
city: Hayward
country: United States
facility: Intarcia
state: California
city: Long Beach
country: United States
facility: Study Site
state: California
city: Los Angeles
country: United States
facility: Study Site
state: California
city: National City
country: United States
facility: Study Site
state: California
city: Port Hueneme
country: United States
facility: Study Site
state: California
city: San Jose
country: United States
facility: Study Site
state: California
city: San Mateo
country: United States
facility: Study Site
state: California
city: Tustin
country: United States
facility: Study Site
state: California
city: Valley Village
country: United States
facility: Study Site
state: California
city: Walnut Creek
country: United States
facility: Study Site
state: California
city: Watsonville
country: United States
facility: Study Site
state: California
city: Colorado Springs
country: United States
facility: Study Site
state: Colorado
city: Colorado Springs
country: United States
facility: Study Site
state: Colorado
city: Boca Raton
country: United States
facility: Study Site
state: Florida
city: Bradenton
country: United States
facility: Study Site
state: Florida
city: Celebration
country: United States
facility: Study Site
state: Florida
city: Clearwater
country: United States
facility: Study Site
state: Florida
city: Coral Gables
country: United States
facility: Study Site
state: Florida
city: Daytona Beach
country: United States
facility: Study Site
state: Florida
city: Hollywood
country: United States
facility: Study Site
state: Florida
city: Jacksonville
country: United States
facility: Study Site
state: Florida
city: Jacksonville
country: United States
facility: Study Site
state: Florida
city: Jacksonville
country: United States
facility: Study Site
state: Florida
city: Miami
country: United States
facility: Study Site
state: Florida
city: Miami
country: United States
facility: Study Site
state: Florida
city: Miami
country: United States
facility: Study Site
state: Florida
city: Miami
country: United States
facility: Study Site
state: Florida
city: Miami
country: United States
facility: Study Site
state: Florida
city: N. Miami Beach
country: United States
facility: Study Site
state: Florida
city: New Port Richey
country: United States
facility: Study Site
state: Florida
city: North Miami Beach
country: United States
facility: Study Site
state: Florida
city: Orlando
country: United States
facility: Study Site
state: Florida
city: Palm Harbor
country: United States
facility: Study Site
state: Florida
city: Pembroke Pines
country: United States
facility: Study Site
state: Florida
city: Ponte Vedra
country: United States
facility: Study Site
state: Florida
city: Tampa
country: United States
facility: Study Site
state: Florida
city: Atlanta
country: United States
facility: Study Site
state: Georgia
city: Canton
country: United States
facility: Study Site
state: Georgia
city: Idaho Falls
country: United States
facility: Study Site
state: Idaho
city: Meridian
country: United States
facility: Study Site
state: Idaho
city: Chicago
country: United States
facility: Study Site
state: Illinois
city: Chicago
country: United States
facility: Study Site
state: Illinois
city: Chicago
country: United States
facility: Study Site
state: Illinois
city: Evansville
country: United States
facility: Study Site
state: Illinois
city: Avon
country: United States
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state: Indiana
city: Evansville
country: United States
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state: Indiana
city: Franklin
country: United States
facility: Study Site
state: Indiana
city: Greenfield
country: United States
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state: Indiana
city: Muncie
country: United States
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state: Indiana
city: Valparaiso
country: United States
facility: Study Site
state: Indiana
city: Des Moines
country: United States
facility: Study Site
state: Iowa
city: Newton
country: United States
facility: Study Site
state: Kansas
city: Metaire
country: United States
facility: Study Site
state: Louisiana
city: Metairie
country: United States
facility: Study Site
state: Louisiana
city: Metarie
country: United States
facility: Study Site
state: Louisiana
city: New Orleans
country: United States
facility: Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Study Site
state: Maryland
city: Brockton
country: United States
facility: Study Site
state: Massachusetts
city: Rochester
country: United States
facility: Study Site
state: Michigan
city: Ypsilanti
country: United States
facility: Study Site
state: Michigan
city: Kansas City
country: United States
facility: Study Site
state: Missouri
city: Billings
country: United States
facility: Study Site
state: Montana
city: Lincoln
country: United States
facility: Study Site
state: Nebraska
city: Las Vegas
country: United States
facility: Study Site
state: Nevada
city: Toms RIver
country: United States
facility: Study Site
state: New Jersey
city: Brooklyn
country: United States
facility: Study Site
state: New York
city: Endwell
country: United States
facility: Study Site
state: New York
city: Staten Island
country: United States
facility: Study Site
state: New York
city: Charlotte
country: United States
facility: Study Site
state: North Carolina
city: Charlotte
country: United States
facility: Study Site
state: North Carolina
city: Durham
country: United States
facility: Study Site
state: North Carolina
city: Greensboro
country: United States
facility: Study Site
state: North Carolina
city: Hickory
country: United States
facility: Study Site
state: North Carolina
city: Moorehead City
country: United States
facility: Study Site
state: North Carolina
city: Mooresville
country: United States
facility: Study Site
state: North Carolina
city: Salisbury
country: United States
facility: Study Site
state: North Carolina
city: Wilmington
country: United States
facility: Study Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Study Site
state: Ohio
city: Cincinnati
country: United States
facility: Study Site
state: Ohio
city: Columbus
country: United States
facility: Study Site
state: Ohio
city: Franklin
country: United States
facility: Study Site
state: Ohio
city: Toledo
country: United States
facility: Study Site
state: Ohio
city: Norman
country: United States
facility: Study Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Study Site
state: Oklahoma
city: Bend
country: United States
facility: Study Site
state: Oregon
city: Uniontown
country: United States
facility: Study Site
state: Pennsylvania
city: Greer
country: United States
facility: Study Site
state: South Carolina
city: N. Myrtle Beach
country: United States
facility: Study Site
state: South Carolina
city: Dakota Dunes
country: United States
facility: Study Site
state: South Dakota
city: Knoxville
country: United States
facility: Study Site
state: Tennessee
city: Memphis
country: United States
facility: Study Site
state: Tennessee
city: Austin
country: United States
facility: Study Site
state: Texas
city: Austin
country: United States
facility: Study Site
state: Texas
city: Carrolton
country: United States
facility: Study Site
state: Texas
city: Corpus Cristi
country: United States
facility: Study Site
state: Texas
city: Dallas
country: United States
facility: Study Site
state: Texas
city: Dallas
country: United States
facility: Study Site
state: Texas
city: Fort Worth
country: United States
facility: Study Site
state: Texas
city: Houston
country: United States
facility: Study Site
state: Texas
city: Houston
country: United States
facility: Study Site
state: Texas
city: Houston
country: United States
facility: Study Site
state: Texas
city: San Angelo
country: United States
facility: Study Site
state: Texas
city: San Antonio
country: United States
facility: Study Site
state: Texas
city: San Antonio
country: United States
facility: Study Site
state: Texas
city: Sugar Land
country: United States
facility: Study Site
state: Texas
city: Tomball
country: United States
facility: Study Site
state: Texas
city: Danville
country: United States
facility: Study Site
state: Virginia
city: Norfolk
country: United States
facility: Study Site
state: Virginia
city: Richmond
country: United States
facility: Study Site
state: Virginia
city: Port Orchard
country: United States
facility: Study Site
state: Washington
city: Renton
country: United States
facility: Study Site
state: Washington
city: Spokane
country: United States
facility: Study Site
state: Washington
Study officials:
References:
citation: Rosenstock J, Buse JB, Azeem R, Prabhakar P, Kjems L, Huang H, Baron MA. Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial. Diabetes Care. 2018 Feb;41(2):333-340. doi: 10.2337/dc17-1306. Epub 2017 Dec 14.