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

• Sponsor: Intarcia Therapeutics (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01455909
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 16.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: ITCA 650 60 mcg/day; Drug: sitagliptin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Jul 1, 2014
• Anticipated Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ITCA 650 60 mcg/day	Drug: ITCA 650 60 mcg/day; exenatide in DUROS
Active Comparator: sitagliptin sitagliptin 100 mg/day	Drug: sitagliptin; sitagliptin oral 100 mg/day

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c [39 weeks]

   39-week treatment period followed by 65-week extension period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HbA1c between 7.5%-10%

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intarcia Therapeutics, Inc	Hayward	California	United States	94545

Sponsors and Collaborators

• Intarcia Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Intarcia Therapeutics
• ClinicalTrials.gov Identifier: NCT01455909
• Other Study ID Numbers: ITCA 650-CLP-110
• First Posted: Oct 20, 2011
• Last Update Posted: Dec 25, 2012
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Sitagliptin Phosphate; Exenatide

Study Results

No Results Posted as of Dec 25, 2012