Study identifier:2993LAR-105 (DURATION - 1)
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications
Type 2 Diabetes Mellitus
Phase 3
No
exenatide, long acting release, exenatide
All
130
Interventional
16 Years +
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Feb 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Exenatide Once Weekly Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide. | - |
Active Comparator: Exenatide Twice Daily subcutaneous injection (SC), twice a day for the first 30 weeks, followed by exenatide LAR SC injection weekly for the remainder of the study. Sub-study: Exenatide 2 mg subcutaneous injection, Administered Using the Exenatide Once Weekly Single-Dose Tray , once a week for 11 visits, switch to Exenatide 2 mg subcutaneous injection, Administered Using the Dual chamber pen device. Exenatide 2mg SC injection administered using the Dual chamber pen device. | - |