A study to compare safety and efficacy of sitagliptin and placebo therapy when added to stable sulfonylurea alone or in combination with metformin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in T2DM participants on sulfonylurea alone or in combination with metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
498
Sitagliptin 100 mg oral tablet once daily for 24 weeks
Matching placebo to sitagliptin oral tablet once daily for 24 weeks
Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.
Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.
Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.
Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
Time frame: Baseline and Week 24
Number of Participants Who Experienced an Adverse Event
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
Time frame: Up to 26 weeks
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.
Time frame: Up to 24 weeks
Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
Time frame: Baseline and Week 24
Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin
This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
Time frame: Baseline and Week 24
Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin
A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
Time frame: Baseline and Week 24
Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.
Time frame: Baseline and Week 24
Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin
This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
Time frame: Baseline and Week 24
Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.
Time frame: Baseline and Week 24
Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin
This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
Time frame: Baseline and Week 24
Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone
This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
Time frame: Baseline and Week 24
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