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Diabetes Obes Metab ; 20(5): 1111-1120, 2018 05.
Article in English | MEDLINE | ID: mdl-29266675

ABSTRACT

AIM: To evaluate the efficacy and safety of ertugliflozin and sitagliptin co-administration vs the individual agents in patients with type 2 diabetes who are inadequately controlled with metformin. METHODS: In this study (Clinicaltrials.gov NCT02099110), patients with glycated haemoglobin (HbA1c) ≥7.5% and ≤11.0% (≥58 and ≤97 mmol/mol) with metformin ≥1500 mg/d (n = 1233) were randomized to ertugliflozin 5 (E5) or 15 (E15) mg/d, sitagliptin 100 mg/d (S100) or to co-administration of E5/S100 or E15/S100. The primary endpoint was change from baseline in HbA1c at Week 26. RESULTS: At Week 26, least squares mean HbA1c reductions from baseline were greater with E5/S100 (-1.5%) and E15/S100 (-1.5%) than with individual agents (-1.0%, -1.1% and -1.1% for E5, E15 and S100, respectively; P < .001 for all comparisons). HbA1c <7.0% (<53 mmol/mol) was achieved by 26.4%, 31.9%, 32.8%, 52.3% and 49.2% of patients in the E5, E15, S100, E5/S100 and E15/S100 groups, respectively. Fasting plasma glucose reductions were significantly greater with E5/S100 and E15/S100 compared with individual agents. Body weight and systolic blood pressure (SBP) significantly decreased with E5/S100 and E15/S100 vs S100 alone. Glycaemic control, body weight and SBP effects of ertugliflozin were maintained to Week 52. Genital mycotic infections were more common among ertugliflozin-treated patients compared with those treated with S100. Incidences of symptomatic hypoglycaemia and adverse events related to hypovolaemia or urinary tract infection were similar among groups. CONCLUSIONS: In patients with uncontrolled type 2 diabetes while using metformin, co-administration of ertugliflozin and sitagliptin provided more effective glycaemic control through 52 weeks compared with the individual agents.


Subject(s)
Bridged Bicyclo Compounds, Heterocyclic/therapeutic use , Diabetes Mellitus, Type 2/drug therapy , Dipeptidyl-Peptidase IV Inhibitors/therapeutic use , Hyperglycemia/prevention & control , Hypoglycemia/prevention & control , Sitagliptin Phosphate/therapeutic use , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Aged , Body Mass Index , Bridged Bicyclo Compounds, Heterocyclic/administration & dosage , Bridged Bicyclo Compounds, Heterocyclic/adverse effects , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/complications , Dipeptidyl-Peptidase IV Inhibitors/adverse effects , Dose-Response Relationship, Drug , Double-Blind Method , Drug Resistance , Drug Therapy, Combination/adverse effects , Female , Follow-Up Studies , Glycated Hemoglobin/analysis , Humans , Hypoglycemia/chemically induced , Hypoglycemic Agents/therapeutic use , Male , Metformin/therapeutic use , Middle Aged , Overweight/complications , Sitagliptin Phosphate/adverse effects , Sodium-Glucose Transporter 2 Inhibitors/administration & dosage , Sodium-Glucose Transporter 2 Inhibitors/adverse effects
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