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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:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01455870
First received: October 18, 2011
Last updated: May 13, 2016
Last verified: May 2016
October 18, 2011
May 13, 2016
May 2013
July 2015   (Final data collection date for primary outcome measure)
Change in HbA1c between Week 52 and Day 0 [ Time Frame: 52 weeks ]
Change in HbA1c [ Time Frame: 39 weeks ]
39-week Treatment Period followed by 65-week Extension Period
Complete list of historical versions of study NCT01455870 on ClinicalTrials.gov Archive Site
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A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes
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
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: ITCA 650 60 mcg/day
    exenatide in DUROS
  • Drug: sitagliptin
    oral sitagliptin 100 mg/day
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
535
July 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Denmark,   Germany,   Latvia,   United States
 
 
NCT01455870
ITCA 650-CLP-105
Yes
Not Provided
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Intarcia Therapeutics
Intarcia Therapeutics
Not Provided
Not Provided
Intarcia Therapeutics
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP