Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.
Full description
This trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks. The study is also designed to examine glucose control during the transition from exenatide twice daily for 30 weeks to exenatide once weekly. Long-term safety and efficacy will be monitored during the open-ended assessment periods. This study will be conducted in approximately 300 subjects with type 2 diabetes treated with diet modification and exercise alone or in combination with a stable regimen of metformin, SU, thiazolidinedione (TZD), a combination of metformin and SU, a combination of metformin and TZD, or a combination of SU and TZD.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.
Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
(For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy
Primary purpose
Allocation
Interventional model
Masking
303 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal