Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943917
• Other study ID #: ITCA 650-CLP-02
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2009
• Last updated: March 23, 2015
• Start date: August 2009
• Est. completion date: February 2011

Study information

• Verified date: March 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: February 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)

Drug:
• Exenatide Injection
twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks

Other:
• Ex Inj/ITCA 650
twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650

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	Bradenton	Florida
United States	Study Site	Charlotte	North Carolina
United States	Study Site	Chicago	Illinois
United States	Study Site	Chino	California
United States	Study Site	Cincinatti	Ohio
United States	Study Site	Cincinnati	Ohio
United States	Study Site	Dallas	Texas
United States	Study Site	Dallas	Texas
United States	Study Site	Eugene	Oregon
United States	Study Site	Franklin	Ohio
United States	Study Site	Hickory	North Carolina
United States	Study Site	Irving	Texas
United States	Study Site	Kalamazoo	Michigan
United States	Study Site	Kettering	Ohio
United States	Study Site	La Jolla	California
United States	Study Site	Las Vegas	Nevada
United States	Study Site	Lexington	Kentucky
United States	Study Site	Longmont	Colorado
United States	Study Site	Meridian	Idaho
United States	Study Site	Miami	Florida
United States	Study Site	Miami	Florida
United States	Study Site	Miami	Florida
United States	Study Site	Minneapolis	Minnesota
United States	Study Site	Miramar	Florida
United States	Study Site	National City	California
United States	Study Site	New Hyde Park	New York
United States	Study Site	New Orleans	Louisiana
United States	Study Site	Norfolk	Virginia
United States	Study Site	Norman	Oklahoma
United States	Study Site	Olympia	Washington
United States	Study Site	Pembroke Pines	Florida
United States	Study Site	Pueblo	Colorado
United States	Study Site	Rapid City	South Dakota
United States	Study Site	Sacramento	California
United States	Study Site	San Antonio	Texas
United States	Study Site	San Antonio	Texas
United States	Study Site	San Diego	California
United States	Study Site	Sandy Springs	Georgia
United States	Study Site	Spokane	Washington
United States	Study Site	St Petersburg	Florida
United States	Study Site	Traverse City	Michigan
United States	Study Site	Troy	Michigan
United States	Study Site	Valley Village	California
United States	Study Site	West Jordan	Utah
United States	Study Site	Wichita	Kansas
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	Mean Change in HbA1c (Per Protocol)	Mean change in HbA1c over first 12 weeks (Stage I)	Day 0 and Week 12	No
Primary	Mean Change in HbA1c (ITT)	Mean change in HbA1c through Week 12	Day 0 to Week 12	No
Primary	Mean Change in HbA1c (Per Protocol)	Mean change in HbA1c through Week 24	Day 0 to Week 24	No
Primary	Mean Change in HbA1c (ITT)	Mean change in HbA1c through Week 24	Day 0 to Week 24	No
Primary	Mean Change in HbA1c (Per Protocol)	Mean change in HbA1c through Week 48	Day 0 to Week 48	No
Primary	Mean Change in HbA1c (ITT)	Mean change in HbA1c through Week 48	Day 0 to Week 48	No