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A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01785771
First received: February 5, 2013
Last updated: March 3, 2014
Last verified: March 2014

February 5, 2013
March 3, 2014
May 2013
September 2014   (final data collection date for primary outcome measure)
Change in HbA1c between Week 39 and Day 0 [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01785771 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c

An 39-week, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
Drug: ITCA 650 (exenatide in DUROS)
Experimental: ITCA 650
Intervention: Drug: ITCA 650 (exenatide in DUROS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men or women age 18 to 80 years with type 2 diabetes
  • On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
  • HbA1c >10.0% and ≤12.0%

Exclusion Criteria:

  • Prior treatment with any GLP-1 receptor agonist
  • History of hypersensitivity to exenatide or liraglutide
  • FPG >300 mg/dL
  • History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
  • Taking DPP-4 inhibitors, incretin mimetics, 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
 
NCT01785771
ITCA 650-CLP-103-Sub-Study
Not Provided
Intarcia Therapeutics
Intarcia Therapeutics
Not Provided
Not Provided
Intarcia Therapeutics
March 2014

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