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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455870
First Posted: October 20, 2011
Last Update Posted: June 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Intarcia Therapeutics
  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: 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

Resource links provided by NLM:


Further study details as provided by Intarcia Therapeutics:

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

Enrollment: 535
Study Start Date: May 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


  Show 54 Study Locations
Sponsors and Collaborators
Intarcia Therapeutics
  More Information

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01455870     History of Changes
Other Study ID Numbers: ITCA 650-CLP-105
First Submitted: October 18, 2011
First Posted: October 20, 2011
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
Exenatide
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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