Clinical trial NCT01455870: A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes
Official title: A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin 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: 535
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 compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* HbA1c between 7.5% - 10.5%
* on metformin monotherapy
* BMI between 25 \& 45 kg/m2

Exclusion Criteria:

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

Primary outcomes:
measure: Change in HbA1c between Week 52 and Day 0
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Tustin
country: United States
state: California
city: Valley Village
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Canton
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Avon
country: United States
state: Indiana
city: Franklin
country: United States
state: Indiana
city: Greenfield
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: Valparaiso
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Metairie
country: United States
state: Louisiana
city: Brockton
country: United States
state: Massachusetts
city: Traverse City
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Brooklyn
country: United States
state: New York
city: Endwell
country: United States
state: New York
city: Morehead City
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Uniontown
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Rijeka
country: Croatia
city: Hvidovre
country: Denmark
city: Bad Lauterberg im Harz
country: Germany
state: Niedersachsen
city: Riga
country: Latvia
Study officials:
References: