A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT01455870
• Recruitment Status: Completed
• First Posted: October 20, 2011
• Last Update Posted: June 2, 2016
• Sponsor: Intarcia Therapeutics
• Information provided by (Responsible Party): Intarcia Therapeutics

Tracking Information

• First Submitted Date: October 18, 2011
• First Posted Date: October 20, 2011
• Last Update Posted Date: June 2, 2016
• Study Start Date: May 2013
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 22, 2013): Change in HbA1c between Week 52 and Day 0 [ Time Frame: 52 weeks ]

Original Primary Outcome Measures (submitted: October 19, 2011)

Change in HbA1c [ Time Frame: 39 weeks ]

39-week Treatment Period followed by 65-week Extension Period

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Brief Summary: Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Type 2 Diabetes

Intervention

• Drug: ITCA 650 60 mcg/day
  exenatide in DUROS
• Drug: sitagliptin
  oral sitagliptin 100 mg/day

Study Arms

• Experimental: ITCA 650 60 mcg/day
  ITCA 650 is exenatide in DUROS
  Intervention: Drug: ITCA 650 60 mcg/day
• Active Comparator: sitagliptin
  sitagliptin 100 mg/day
  Intervention: Drug: sitagliptin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2015): 535
• Original Estimated Enrollment (submitted: October 19, 2011): 500
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Croatia, Denmark, Germany, Latvia, United States

Administrative Information

• NCT Number: NCT01455870
• Other Study ID Numbers: ITCA 650-CLP-105
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Intarcia Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Intarcia Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Intarcia Therapeutics
• Verification Date: May 2016