The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
286
5 mg, oral tablet, once daily
500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy
Absolute Change From Baseline in HbA1c at Week 24
Time frame: Baseline and 24 weeks
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%
Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent
Time frame: 24 Weeks
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%
Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent
Time frame: 24 Weeks
Change From Baseline to Week 24 in Fasting Plasma Glucose
Time frame: Baseline and 24 weeks
Change From Baseline to Week 24 in Fasting Insulin
Time frame: Baseline and 24 weeks
Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta
Time frame: Baseline and 24 weeks
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Research Site
Brussels (woluwe-st-lambert), Belgium, Belgium
Research Site
Halen, Belgium, Belgium
Research Site
Lommel, Belgium, Belgium
Research Site
Oostham, Belgium, Belgium
Research Site
Sint-Gillis-Waas, Belgium, Belgium
Research Site
Zoersel, Belgium, Belgium
Research Site
Bruges, Belgium
Research Site
Moerkerke, Belgium
Research Site
Tielt, Belgium
Research Site
Châtellerault, France
...and 41 more locations