This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
370
initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks
as prescribed
10mg sc weekly, 24 (-52) weeks
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijng, China
Unnamed facility
Chengdu, China
Unnamed facility
Chongqing, China
Glycemic control assessed by HbA1c
Time frame: week 24
Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c
Time frame: week 24
Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)
Time frame: week 24
Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters
Time frame: throughout study, laboratory assessments weeks 12, 24, 32 and 52
Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values
Time frame: week 24
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Unnamed facility
Guangzhou, China
Unnamed facility
Hangzhou, China
Unnamed facility
Hefei, China
Unnamed facility
Nanjing, China
...and 46 more locations