Clinical trial NCT00943917: Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
Official title: Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Males or females age 18-70 years
* Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
* On a stable (\> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
* Fasting plasma glucose \< 240 mg/dL at Screening Visit 1
* HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

Exclusion Criteria:

* Prior treatment with exenatide
* Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
* History of type 1 diabetes and/or history of diabetic ketoacidosis
* Body mass index ≥ 40 kg/m2;
* History of organ transplantation

Primary outcomes:
measure: Mean Change in HbA1c (Per Protocol)
timeFrame: Day 0 and Week 12
measure: Mean Change in HbA1c (ITT)
timeFrame: Day 0 to Week 12
measure: Mean Change in HbA1c (Per Protocol)
timeFrame: Day 0 to Week 24
measure: Mean Change in HbA1c (ITT)
timeFrame: Day 0 to Week 24
measure: Mean Change in HbA1c (Per Protocol)
timeFrame: Day 0 to Week 48
measure: Mean Change in HbA1c (ITT)
timeFrame: Day 0 to Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Chino
country: United States
facility: Study Site
state: California
city: La Jolla
country: United States
facility: Study Site
state: California
city: National City
country: United States
facility: Study Site
state: California
city: Sacramento
country: United States
facility: Study Site
state: California
city: San Diego
country: United States
facility: Study Site
state: California
city: Valley Village
country: United States
facility: Study Site
state: California
city: Longmont
country: United States
facility: Study Site
state: Colorado
city: Pueblo
country: United States
facility: Study Site
state: Colorado
city: Bradenton
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: Miramar
country: United States
facility: Study Site
state: Florida
city: Pembroke Pines
country: United States
facility: Study Site
state: Florida
city: St Petersburg
country: United States
facility: Study Site
state: Florida
city: Atlanta
country: United States
facility: Study Site
state: Georgia
city: Sandy Springs
country: United States
facility: Study Site
state: Georgia
city: Meridian
country: United States
facility: Study Site
state: Idaho
city: Chicago
country: United States
facility: Study Site
state: Illinois
city: Avon
country: United States
facility: Study Site
state: Indiana
city: Wichita
country: United States
facility: Study Site
state: Kansas
city: Lexington
country: United States
facility: Study Site
state: Kentucky
city: New Orleans
country: United States
facility: Study Site
state: Louisiana
city: Kalamazoo
country: United States
facility: Study Site
state: Michigan
city: Traverse City
country: United States
facility: Study Site
state: Michigan
city: Troy
country: United States
facility: Study Site
state: Michigan
city: Ypsilanti
country: United States
facility: Study Site
state: Michigan
city: Minneapolis
country: United States
facility: Study Site
state: Minnesota
city: Las Vegas
country: United States
facility: Study Site
state: Nevada
city: New Hyde Park
country: United States
facility: Study Site
state: New York
city: Charlotte
country: United States
facility: Study Site
state: North Carolina
city: Hickory
country: United States
facility: Study Site
state: North Carolina
city: Cincinatti
country: United States
facility: Study Site
state: Ohio
city: Cincinnati
country: United States
facility: Study Site
state: Ohio
city: Franklin
country: United States
facility: Study Site
state: Ohio
city: Kettering
country: United States
facility: Study Site
state: Ohio
city: Norman
country: United States
facility: Study Site
state: Oklahoma
city: Eugene
country: United States
facility: Study Site
state: Oregon
city: Rapid City
country: United States
facility: Study Site
state: South Dakota
city: Austin
country: United States
facility: Study Site
state: Texas
city: Austin
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: Irving
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: West Jordan
country: United States
facility: Study Site
state: Utah
city: Norfolk
country: United States
facility: Study Site
state: Virginia
city: Olympia
country: United States
facility: Study Site
state: Washington
city: Spokane
country: United States
facility: Study Site
state: Washington
Study officials:
References:
citation: Henry RR, Rosenstock J, Logan DK, Alessi TR, Luskey K, Baron MA. Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes. Diabetes Care. 2013 Sep;36(9):2559-65. doi: 10.2337/dc12-2410. Epub 2013 May 3.