LivingGLP1
Study S001812

Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Included trial: extracted dataClinicalTrials.gov record

Registration

Registration
NCT00943917
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2
Masking
NONE
Status
COMPLETED
Enrollment
155
Start
2009-08
Primary completion
2010-08
Lead sponsor
Intarcia Therapeutics
Conditions
Type 2 Diabetes
Interventions
OTHER:ITCA 650; DRUG:Exenatide Injection; OTHER:Ex Inj/ITCA 650
Results posted
TRUE

Registered primary outcomes

  • Mean Change in HbA1c (Per Protocol) [Day 0 and Week 12]
  • Mean Change in HbA1c (ITT) [Day 0 to Week 12]
  • Mean Change in HbA1c (Per Protocol) [Day 0 to Week 24]
  • Mean Change in HbA1c (ITT) [Day 0 to Week 24]
  • Mean Change in HbA1c (Per Protocol) [Day 0 to Week 48]
  • Mean Change in HbA1c (ITT) [Day 0 to Week 48]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0019710Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes.
Henry RR, Diabetes care
2013Randomized trialPMID 23645886DOIcites ClinicalTrials.gov:NCT00943917; registry reference DERIVED:23645886
R0035661Long-Term Injection-Free Subcutaneous Delivery of Exenatide via ITCA 650 Improves Compliance and Controls Glycemic Parameters and Weight
R. Buckely, MD Conference Express
2011Randomized trialDOIcites ClinicalTrials.gov:NCT00943917