A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01455922
First received: October 18, 2011
Last updated: December 21, 2012
Last verified: December 2012

October 18, 2011
December 21, 2012
February 2013
July 2014   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
52-week Treatment Period followed by 52-week Extension Period
Change in HbA1c [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01455922 on ClinicalTrials.gov Archive Site
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A Study to Evaluate ITCA 650 Compared to Glimepiride 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 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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: ITCA 650
    ITCA 650 is exenatide in DUROS
  • Drug: glimepiride
    glimepiride will be up-titrated to 8 mg/day over first 13 weeks
  • Experimental: ITCA 650 60 mcg/day
    Intervention: Drug: ITCA 650
  • Active Comparator: glimepiride
    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Withdrawn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, sulfonylurea, DPP-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months
  • history of pancreatitis
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01455922
ITCA 650-CLP-112
Not Provided
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