This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is \>500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,189
5mg twice daily for 4 weeks followed by 10mg twice daily
10mg once weekly
10mg once weekly for 4 weeks followed by 20mg once weekly
Unnamed facility
Haleyville, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Montgomery, Alabama, United States
Unnamed facility
Tuscaloosa, Alabama, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Change in HbA1c
Time frame: 24 weeks
Fasting body weight
Time frame: 24 weeks
Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
Time frame: 24 weeks
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
Time frame: 24 weeks
Beta cell function (proinsulin/insulin ratio)
Time frame: 24 weeks
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Escondido, California, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Mission Viejo, California, United States
Unnamed facility
Orange, California, United States
Unnamed facility
Palm Springs, California, United States
...and 206 more locations