ABSTRACT
AIMS: To confirm superiority on glycaemic control by switching from sitagliptin to liraglutide 1.8 mg/d versus continued sitagliptin. MATERIALS AND METHODS: A randomized, multicentre, double-blind, double-dummy, active-controlled trial across 86 office- or hospital-based sites in North America, Europe and Asia. Subjects with type 2 diabetes who had inadequate glycaemic control (glycated haemoglobin [HbA1c] 7.5-9.5% on sitagliptin (100 mg/d) and metformin (≥1500 mg daily) for ≥90 days were randomized to either switch to liraglutide (n = 203) or continue sitagliptin (n = 204), both with metformin. The primary endpoint was change in HbA1c from baseline to week 26. Change in body weight was a confirmatory secondary endpoint. RESULTS: Greater reduction in mean HbA1c was achieved with liraglutide than with continued sitagliptin [-1.14% vs. -0.54%; estimated mean treatment difference (ETD): -0.61% (95% CI -0.82 to -0.40; p < 0.0001)], confirming superiority of switching to liraglutide. Body weight was reduced more with liraglutide [-3.31 kg vs. -1.64 kg; ETD: -1.67 kg (95% CI -2.34 to -0.99; p < 0.0001)]. Nausea was more common with liraglutide [44 subjects (21.8%)] than with continued sitagliptin [16 (7.8%)]. Three subjects (1.5%) taking sitagliptin reported a confirmed hypoglycaemic episode. CONCLUSIONS: Subjects insufficiently controlled with sitagliptin who switch to liraglutide can obtain clinically relevant reductions in glycaemia and body weight, without compromising safety. A switch from sitagliptin to liraglutide provides an option for improved management of type 2 diabetes while still allowing patients to remain on dual therapy.
Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Liraglutide/therapeutic use , Sitagliptin Phosphate/therapeutic use , Adult , Aged , Aged, 80 and over , Asia , Blood Glucose/metabolism , Body Weight , Diabetes Mellitus, Type 2/metabolism , Double-Blind Method , Drug Substitution , Drug Therapy, Combination , Europe , Female , Glycated Hemoglobin/metabolism , Humans , Hypoglycemia/chemically induced , Male , Metformin/therapeutic use , Middle Aged , Nausea/chemically induced , North America , Treatment OutcomeSubject(s)
Glucagon/therapeutic use , Osteitis Deformans/drug therapy , Plicamycin/therapeutic use , Adult , Aged , Aspartate Aminotransferases/blood , Blood Glucose/analysis , Drug Therapy, Combination , Glucagon/administration & dosage , Glucagon/adverse effects , Humans , L-Lactate Dehydrogenase/blood , Middle Aged , Osteitis Deformans/metabolism , Plicamycin/administration & dosage , Plicamycin/adverse effects , Time FactorsABSTRACT
Twenty-seven patients with symptomatic Paget's disease of bone were randomly treated with mithramycin, glucagon, and calcitonin given either alone or in combination. Mithramycin, at a dose of fifteen micrograms per kilogram of body weight per day, proved to be a relatively safe drug and elicited a rapid response with only transient side effects. Calcitonin combined with mithramycin was the most effective therapy.
