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

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 535 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 : May 2013
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in HbA1c between Week 52 and Day 0 [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455870

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Sponsors and Collaborators
Intarcia Therapeutics

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01455870     History of Changes
Other Study ID Numbers: ITCA 650-CLP-105
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016

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