A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455857
• Other study ID #: ITCA 650-CLP-103
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2011
• Last updated: July 28, 2015
• Start date: March 2013
• Est. completion date: September 2014

Study information

• Verified date: July 2015
• Source: Intarcia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• ITCA 650
ITCA 650 is exenatide in DUROS

Other:
• ITCA placebo
Formulation in DUROS (no exenatide)

Locations

Country	Name	City	State
United States	Study Site	Atlanta	Georgia
United States	Study Site	Austin	Texas
United States	Study Site	Austin	Texas
United States	Study Site	Avon	Indiana
United States	Study Site	Baltimore	Maryland
United States	Study Site	Bend	Oregon
United States	Study Site	Billings	Montana
United States	Study Site	Birmingham	Alabama
United States	Study Site	Boca Raton	Florida
United States	Study Site	Bradenton	Florida
United States	Study Site	Brockton	Massachusetts
United States	Study Site	Brooklyn	New York
United States	Study Site	Canton	Georgia
United States	Study Site	Carrolton	Texas
United States	Study Site	Celebration	Florida
United States	Study Site	Chandler	Arizona
United States	Study Site	Charlotte	North Carolina
United States	Study Site	Charlotte	North Carolina
United States	Study Site	Chicago	Illinois
United States	Study Site	Chicago	Illinois
United States	Study Site	Chicago	Illinois
United States	Study Site	Chula Vista	California
United States	Study Site	Cincinnati	Ohio
United States	Study Site	Cincinnati	Ohio
United States	Study Site	Clearwater	Florida
United States	Study Site	Colorado Springs	Colorado
United States	Study Site	Colorado Springs	Colorado
United States	Study Site	Columbus	Ohio
United States	Study Site	Coral Gables	Florida
United States	Study Site	Corpus Cristi	Texas
United States	Study Site	Dakota Dunes	South Dakota
United States	Study Site	Dallas	Texas
United States	Study Site	Dallas	Texas
United States	Study Site	Danville	Virginia
United States	Study Site	Daytona Beach	Florida
United States	Study Site	Des Moines	Iowa
United States	Study Site	Durham	North Carolina
United States	Study Site	Endwell	New York
United States	Study Site	Evansville	Illinois
United States	Study Site	Evansville	Indiana
United States	Study Site	Fort Worth	Texas
United States	Study Site	Franklin	Ohio
United States	Study Site	Franklin	Indiana
United States	Study Site	Fresno	California
United States	Study Site	Goodyear	Arizona
United States	Study Site	Greenfield	Indiana
United States	Study Site	Greensboro	North Carolina
United States	Study Site	Greer	South Carolina
United States	Study Site	Gulf Shores	Alabama
United States	Intarcia	Hayward	California
United States	Study Site	Hickory	North Carolina
United States	Study Site	Hollywood	Florida
United States	Study Site	Houston	Texas
United States	Study Site	Houston	Texas
United States	Study Site	Houston	Texas
United States	Study Site	Huntsville	Alabama
United States	Study Site	Idaho Falls	Idaho
United States	Study Site	Jacksonville	Florida
United States	Study Site	Jacksonville	Florida
United States	Study Site	Jacksonville	Florida
United States	Study Site	Kansas City	Missouri
United States	Study Site	Knoxville	Tennessee
United States	Study Site	Las Vegas	Nevada
United States	Study Site	Lincoln	Nebraska
United States	Study Site	Little Rock	Arkansas
United States	Study Site	Long Beach	California
United States	Study Site	Los Angeles	California
United States	Study Site	Memphis	Tennessee
United States	Study Site	Meridian	Idaho
United States	Study Site	Metaire	Louisiana
United States	Study Site	Metairie	Louisiana
United States	Study Site	Metarie	Louisiana
United States	Study Site	Miami	Florida
United States	Study Site	Miami	Florida
United States	Study Site	Miami	Florida
United States	Study Site	Miami	Florida
United States	Study Site	Miami	Florida
United States	Study Site	Moorehead City	North Carolina
United States	Study Site	Mooresville	North Carolina
United States	Study Site	Muncie	Indiana
United States	Study Site	N. Miami Beach	Florida
United States	Study Site	N. Myrtle Beach	South Carolina
United States	Study Site	National City	California
United States	Study Site	New Orleans	Louisiana
United States	Study Site	New Port Richey	Florida
United States	Study Site	Newton	Kansas
United States	Study Site	Norfolk	Virginia
United States	Study Site	Norman	Oklahoma
United States	Study Site	North Miami Beach	Florida
United States	Study Site	Oklahoma City	Oklahoma
United States	Study Site	Orlando	Florida
United States	Study Site	Palm Harbor	Florida
United States	Study Site	Pembroke Pines	Florida
United States	Study Site	Phoenix	Arizona
United States	Study Site	Ponte Vedra	Florida
United States	Study Site	Port Hueneme	California
United States	Study Site	Port Orchard	Washington
United States	Study Site	Renton	Washington
United States	Study Site	Richmond	Virginia
United States	Study Site	Rochester	Michigan
United States	Study Site	Salisbury	North Carolina
United States	Study Site	San Angelo	Texas
United States	Study Site	San Antonio	Texas
United States	Study Site	San Antonio	Texas
United States	Study Site	San Jose	California
United States	Study Site	San Mateo	California
United States	Study Site	Spokane	Washington
United States	Study Site	Staten Island	New York
United States	Study Site	Sugar Land	Texas
United States	Study Site	Tampa	Florida
United States	Study Site	Toledo	Ohio
United States	Study Site	Tomball	Texas
United States	Study Site	Toms RIver	New Jersey
United States	Study Site	Tustin	California
United States	Study Site	Uniontown	Pennsylvania
United States	Study Site	Valley Village	California
United States	Study Site	Valparaiso	Indiana
United States	Study Site	Walnut Creek	California
United States	Study Site	Watsonville	California
United States	Study Site	Wilmington	North Carolina
United States	Study Site	Winston-Salem	North Carolina
United States	Study Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Intarcia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	39-week Treatment Period	39 weeks	No