LivingGLP1
Study S002251

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Pharmacokinetics of Exenatide Long-Acting Release Administered Weekly in Subjects With Type 2 Diabetes Mellitus

Registration

Registration
NCT00103935
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2
Masking
DOUBLE
Status
COMPLETED
Enrollment
45
Start
2005-02
Primary completion
2005-10
Lead sponsor
AstraZeneca
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG:placebo; DRUG:Exenatide LAR
Results posted
FALSE

Registered primary outcomes

  • Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM) [Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours]

Linked records (1)

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
R0020722Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing.
Fineman M, Clinical pharmacokinetics
2011Nonrandomized studyPMID 21142268DOIcites ClinicalTrials.gov:NCT00103935; registry reference DERIVED:21142268