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Journal

Efficacy and safety of sitagliptin added to ongoing metformin and pioglitazone combination therapy in a randomized, placebo-controlled, 26-week trial in patients with type 2 diabetes

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Published:25th Mar 2020
Aims: To assess efficacy and safety of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in combination therapy with metformin (?1500mg/day) and pioglitazone (?30mg/day) in patients with type 2 diabetes (T2DM) with inadequate glycemic control (hemoglobin A1c [HbA1c] ?7.5% and ?11%). Methods: This placebo-controlled, double-blind study included 313 patients, mean baseline HbA1c=8.7%, who were randomized to receive sitagliptin 100mg/day or placebo for 26weeks. Results: The addition of sitagliptin led to significant (P<.001) mean changes from baseline relative to placebo in hba1c (?0.7%), fasting plasma glucose (?1.0mmol l), and 2-h post-meal glucose (?2.2mmol l). in patients with baseline hba1c ?9.0%, mean changes from baseline in hba1c were ?1.6% and ?0.8% for the sitagliptin and placebo groups, respectively (between-group difference ?0.8%; p><.001). the incidences of reported adverse events were generally similar between the treatment groups. incidences of symptomatic hypoglycemia were 7 157 [4.5%] and 6 156 [3.8%] in the sitagliptin and placebo groups, respectively (p=".786)." two patients, both in the placebo group, experienced an episode of hypoglycemia that required non-medical assistance. conclusions: in this 26-week study, addition of sitagliptin to combination therapy with metformin and pioglitazone improved glycemic control and was generally well tolerated.>

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