This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
Research Site
Birmingham, Alabama, United States
Research Site
Concord, California, United States
Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)
Time frame: baseline and 26 weeks
Percentage of Patients Achieving HbA1c <= 7%
Percentage of intent-to-treat (ITT) patients who had HbA1c \> 7% at baseline that decreased to \<= 7% at endpoint (Week 26 or early discontinuation)
Time frame: 26 weeks
Percentage of Patients Achieving HbA1c <= 6.5%
Percentage of ITT patients who had achieved HbA1c \<= 6.5% at endpoint (Week 26 or early discontinuation)
Time frame: 26 weeks
Change in Fasting Serum Glucose (FSG)
Change in FSG from baseline to endpoint (26 weeks)
Time frame: baseline and 26 weeks
Change in Body Weight
Change in body weight from baseline to endpoint (26 weeks)
Time frame: baseline and 26 weeks
Change in Waist Circumference
Change in waist circumference from baseline to endpoint (26 weeks)
Time frame: baseline and 26 weeks
Change in Beta-cell Function
Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function.
Time frame: baseline and 26 weeks
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Research Site
Fresno, California, United States
Research Site
Denver, Colorado, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Mogadore, Ohio, United States
Research Site
Corvallis, Oregon, United States
Research Site
New Westminster, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Ajax, Ontario, Canada
...and 15 more locations
Change in Insulin Sensitivity.
Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S).
Time frame: baseline and 26 weeks
Number of Subjects Who Experienced an Episode of Minor Hypoglycemia
Overall number of subjects who experienced an episode of minor hypoglycemia.
Time frame: 26 weeks
Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score
IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = "never true" to 5 = "always true."
Time frame: baseline and 26 weeks
Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score
EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state.
Time frame: baseline and 26 weeks