This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels
Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks
Research Site
Westmead, New South Wales, Australia
Research Site
Daw Park, South Australia, Australia
Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.
Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.
Time frame: Baseline, Week 16, Week 32
Change in patient-reported outcomes from Baseline to the end of each 16-week period
Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires \[Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument\] from Baseline to the end of each 16-week exenatide or insulin glargine period
Time frame: Baseline, Week 16, Week 32
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Research Site
Fullarton, South Australia, Australia
Research Site
Box Hill, Victoria, Australia
Research Site
East Ringwood, Victoria, Australia
Research Site
Athens, Greece
Research Site
Piraeus, Greece
Research Site
Thessaloniki, Greece
Research Site
Budapest, Hungary
Research Site
Gyula, Hungary
...and 16 more locations