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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01455857
First received: October 18, 2011
Last updated: September 30, 2014
Last verified: September 2014

October 18, 2011
September 30, 2014
March 2013
August 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
Change in HbA1c [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
39-week Treatment Period followed by 65-week Extension Period
Complete list of historical versions of study NCT01455857 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes

Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy 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
  • Other: ITCA placebo
    Formulation in DUROS (no exenatide)
  • Experimental: ITCA 650 40 mcg/day
    Intervention: Drug: ITCA 650
  • Experimental: ITCA 650 60 mcg/day
    Intervention: Drug: ITCA 650
  • Placebo Comparator: ITCA placebo
    Intervention: Other: ITCA placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
September 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HbA1c between 7.5% - 10%
  • On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
  • BMI between 25 & 45 kg/m2

Exclusion Criteria:

  • taking DPP-4 inhibitors, exenatide, liraglutide, 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
 
NCT01455857
ITCA 650-CLP-103
Yes
Intarcia Therapeutics
Intarcia Therapeutics
Not Provided
Not Provided
Intarcia Therapeutics
September 2014

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