A Study to Evaluate ITCA 650 Compared to Sitagliptin 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This study has been withdrawn prior to enrollment.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:
NCT01455909
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: 39 weeks ] [ Designated as safety issue: No ]
39-week treatment period followed by 65-week extension period
Same as current
Complete list of historical versions of study NCT01455909 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate ITCA 650 Compared to Sitagliptin 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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: ITCA 650 60 mcg/day
    exenatide in DUROS
  • Drug: sitagliptin
    sitagliptin oral 100 mg/day
  • Experimental: ITCA 650 60 mcg/day
    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.
 
Withdrawn
0
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HbA1c between 7.5%-10%
  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01455909
ITCA 650-CLP-110
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