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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455883
First Posted: October 20, 2011
Last Update Posted: December 25, 2012
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
October 18, 2011
October 20, 2011
December 25, 2012
February 2013
July 2014   (Final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: 52 weeks ]
52-Week Treatment Period
Change in HbA1c [ Time Frame: 52 weeks ]
52-Week Treatment Period followed by 52-Week Extension Period
Complete list of historical versions of study NCT01455883 on ClinicalTrials.gov Archive Site
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A Study to Evaluate ITCA 650 Compared to Glimepiride 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 Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: ITCA 650 60 mcg/day
    exenatide in DUROS
  • Drug: glimepiride
    oral glimepiride does-escalated,if tolerated, to 8 mg/day
  • Experimental: ITCA 650 60 mcg/day
    ITCA 650 is exenatide in DUROS
    Intervention: Drug: ITCA 650 60 mcg/day
  • Active Comparator: glimepiride
    glimepiride up-titrated to 8 mg/day over first 13 weeks
    Intervention: Drug: glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2014
July 2014   (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:

  • on thiazolidinedione, sulfonylureas, 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
United States
 
 
NCT01455883
ITCA 650-CLP-106
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Intarcia Therapeutics
Intarcia Therapeutics
Not Provided
Not Provided
Intarcia Therapeutics
December 2012

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