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

This study is not yet open for participant recruitment.
Verified February 2013 by Intarcia Therapeutics
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01455870
First received: October 18, 2011
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:
  • Change in HbA1c between Week 52 and Day 0 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITCA 650 60 mcg/day
ITCA 650 is exenatide in DUROS
 Drug: ITCA 650 60 mcg/day
exenatide in DUROS
Active Comparator: sitagliptin
sitagliptin 100 mg/day
 Drug: sitagliptin
oral sitagliptin 100 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455870

Contacts
Contact: Michelle Baron, MD, FACE clinicaltrials@intarcia.com

Locations
United States, California
Intarcia Therapeutics, Inc Not yet recruiting
Hayward, California, United States, 94545
Contact: Michelle Baron, MD, FACE         clinicaltrials@intarcia.com    
Sponsors and Collaborators
Intarcia Therapeutics
  More Information

No publications provided

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01455870     History of Changes
Other Study ID Numbers: ITCA 650-CLP-105
Study First Received: October 18, 2011
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013