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SummaryAims: To assess the safety and efficacy of omarigliptin in subjects with type 2 diabetes mellitus (T2DM) and chronic renal impairment (RI). Methods:Patients with T2DM with moderate RI (estimated glomerular filtration rate[eGFR] ≥30 to <60 mL/min/1.73 m 2 ) (N=114), severe RI (eGFR <30 mL/min/1.73 m 2 ) (N=55) or end-stage renal disease on dialysis (N=44), who were either not on an antihyperglycaemic agent therapy for at least 12 weeks at screening, washed-off of oral antihyperglycaemic agent monotherapy or low-dose dual combination therapy, or on insulin monotherapy, with baseline glycated haemoglobin (HbA1c) of 6.5%-10.0% were randomised to omarigliptin or to placebo for 24 weeks (primary end-point) followed by a 30-week period with subjects on placebo switched to blinded glipizide (if not on insulin).Results: After 24 weeks, from a mean baseline HbA1c of 8.4% in the omarigliptin group and 8.3% in the placebo group, the least squares mean (95% CI) change from baseline in HbA1c in the overall population (all renal strata combined) was −0.77% (−1.00 to −0.54) in the omarigliptin group and −0.44% (−0.67 to −0.21) in the placebo group; between-group difference of −0.33% (−0.63 to −0.02); P=0.035. After 24 weeks, the incidences of subjects with symptomatic hypoglycaemia, one or more adverse event (AE), drug-related AE, serious AE and discontinuation due to an AE were similar in the omarigliptin and placebo groups. Conclusions:In this study in subjects with T2DM and RI, relative to placebo, omarigliptin provided clinically meaningful reductions in HbA1c, had a similar incidence of symptomatic hypoglycaemia and was generally well tolerated.

This study compared the efficacy and safety of the cyclooxygenase-2 specific inhibitor celecoxib with the conventional non-steroidal anti-inflammatory drug diclofenac in the symptomatic treatment of viral pharyngitis. Adult patients from 27 study centers in Latin America were treated with oral doses of celecoxib 200 mg once daily or 200 mg twice daily, or diclofenac 75 mg twice daily for 5 days in a double-blind, randomized study. The primary efficacy assessment was 'Throat Pain on Swallowing' on day 3. In addition, secondary quality-of-life assessments were performed on days 3 and 5. All adverse events and treatment-emergent signs and symptoms were recorded. Data from 313 patients were evaluable for efficacy (105 celecoxib 200 mg once daily, 107 celecoxib 200 mg twice daily, 101 diclofenac 75 mg twice daily). The upper 95% confidence limits for the visual analog scale of 'Throat Pain on Swallowing' on day 3 for celecoxib 200 mg once daily relative to diclofenac 75 mg twice daily, and celecoxib 200 mg twice daily relative to diclofenac 75 mg twice daily were 9.26 and 7.83, respectively. All secondary efficacy and quality-of-life measures were clinically similar for the three treatment groups, and no statistically significant differences were detected. The incidences of treatment-emergent adverse events and withdrawals due to adverse events were similar for all groups, but numerically higher among patients taking diclofenac than celecoxib. More patients in the diclofenac group reported gastrointestinal complaints (7.3%) compared with those in the celecoxib groups (4.3% in the celecoxib 200 mg once-daily group and 3.4% in the celecoxib 200 mg twice-daily group). In conclusion, 5 days of treatment with celecoxib 200 mg once daily is as effective as diclofenac 75 mg twice daily in the symptomatic treatment of viral pharyngitis. Celecoxib 200 mg once daily is also as effective as celecoxib 200 mg twice daily in this condition.

Background We examined the efficacy and safety of corifollitropin alfa (CFA) combined with human chorionic gonadotropin (hCG) for the induction of testicular growth and pubertal development in adolescent boys with hypogonadotropic hypogonadism (HH). Methods This was a 64-week, multi-center, open-label, single-group study of CFA in adolescent males, 14 to &lt;18 years of age, with HH. Seventeen participants initiated a 12-week priming period with CFA (100 μg if weight ≤60 kg, or 150 μg if weight &gt;60 kg) given subcutaneously (SC) once every two weeks (q2wk), after which they entered a 52-week combined treatment period with CFA, q2wk, and SC hCG, twice-weekly (hCG dose adjusted between 500 IU and 5,000 IU to keep total testosterone and estradiol levels within protocol-specified ranges). The primary efficacy endpoint was change from baseline in testicular volume (TV), measured as the sum of volumes of left and right testes by ultrasound. Results After 64 weeks of therapy with CFA/CFA combined with hCG, geometric mean fold increase from baseline in TV was 9.43 [95% CI: 7.44, 11.97] (arithmetic mean of change from baseline at Week 64, 13.0 mL). Hormonal, Tanner stage, and growth velocity changes were consistent with initiation and progression of puberty. Treatment was generally well tolerated. No participant developed anti-CFA antibodies. Conclusions Treatment of adolescent males with HH with CFA alone for 12 weeks followed by CFA combined with hCG for 52 weeks induced testicular growth accompanied by pubertal progression, increased testosterone, and a pubertal growth spurt. (EudraCT: 2015-001878-18)