glp 1 meds demonstrate here that liraglutide can exert a strong protective effect on lethal renal IRI in mice. This protection appears to be related to the inhibition of HMGB1 nuclear-cytoplasmic translocation and release and partially depends on GLP-1R. Thus, liraglutide may be glp-1 inhibitors for the clinical prevention and Analysis of efficacy and safety of dulaglutide 05 mg stratified by sex in patients with type 2 diabetes in 2 randomized, controlled phase 3 studies in We analyzed the efficacy and safety of once weekly dulaglutide 05 mg by sex in 2 randomized, controlled phase 3 studies in Japanese patients with type 2 diabetes (a 52-week monotherapy study [comparator liraglutide 0 mg] and a 26-week combination therapy study [comparator insulin glargine]). Females comprised 18% of patients in the monotherapy study and 29% of patients in the combination therapy study. Mean reductions from baseline in glycated hemoglobin (HbA1c) were similar between the sexes for dulaglutide- and liraglutide-treated patients (range -17% to -19%). Females had numerically greater weight loss or less weight gain than males across all treatment groups. The percentages of patients with reductions in both HbA1c and weight from baseline were also greater for females than for males in all treatment groups. In all treatment groups, the incidences of treatment-emergent adverse events tended to be greater among females than among males. No differences in the incidences of total or nocturnal hypoglycemia were observed between the sexes in any treatment group. Overall, in 2 studies in Japan, across all treatment groups it appeared that HbA1c lowering was unaffected by patient sex, while female patients had greater weight loss or less weight gain and greater incidence of adverse events, including nausea, compared to male patients. Incidences of patients discontinuing dulaglutide early due to adverse event were low (<10%) for both sexes, and no new safety concerns related to dulaglutide were identified for either sex. Therefore, the benefit/risk ratio for dulaglutide remains unchanged, Effect of Adding Liraglutide vs Placebo to a High-Dose lnsulin Regimen in Patients With Type 2 Diabetes: A Randomized Clinical Trial.Texas Southwestern Medical Center, Dallas. Texas Southwestern Medical Center, Dallas2Texas Diabetes and Endocrinology, Texas Southwestern Medical Center, Dallas.Texas Southwestern Medical Center, Dallas4Division of Mineral Metabolism, Department of Internal Medicine, University of Texas Southwestern Medical Texas Southwestern Medical Center, Dallas3Division of Biostatistics, Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas.IMPORTANCE: An increasing number of patients with type 2 diabetes are treated with high doses of insulin. Such treatment is associated with weight gain, hypoglycemia, and high treatment burden.OBJECTIVE: To assess the effectiveness and safety of adding a glucagon-like peptide 1 receptor agonist to the treatment regimen of patients with type 2 diabetes requiring therapy with high-dose insulin.DESIGN, SETTING, AND PARTICIPANTS: This clinical trial was a double-blind, placebo-controlled, randomized (1:1) study with 6 months of follow-up, conducted from August 13, 2012, to February 9, 2015, at ambulatory clinics at the University of Texas Southwestern Medical Center and Parkland Hospital. Participants were 71 patients with uncontrolled type 2 diabetes (glycated hemoglobin level, 7%-11%) using more than 1 U/kg/d of insulin. INTERVENTIONS: Subcutaneous injection of liraglutide (1 mg/d) or matching MAIN OUTCOMES AND MEASURES: The primary outcome was the change in glycated hemoglobin level. Secondary outcomes were changes in weight, hypoglycemia rate, insulin dosage, and quality-of-life measures.RESULTS: Among 71 patients, 45 (63%) were female. The mean (SD) age of patients was 54 (7) years, with a mean (SD) type 2 diabetes duration of 17 (8) years and a mean (SD) total daily dose of insulin of 247 (95) U. Ninety-three percent (66 of 71) of participants completed all scheduled visits. The glycated hemoglobin level improved from a mean (SD) of 9% (1%) to 7% (1%) in the liraglutide group (P < 01) and remained unchanged (8%) in the placebo group, with an estimated treatment difference of 0% (95% CI, -1 to -0) (P = 02). Weight decreased from a mean (SD) of 114 (21) kg to 113 (20) kg in the liraglutide group vs a mean (SD) increase from 116 (26) kg to 117 (27) kg in the placebo group, with a treatment difference of -2 kg (95% CI, -4 to -0 kg) (P = 2). The total daily dose of insulin decreased 11% (95% CI, -21% to -1%) in the liraglutide group (P = 0). The hypoglycemia rate was higher in the first month after initiation of liraglutide compared with placebo (20 vs 01 events per person-month, P = 1), while the overall hypoglycemia rate over the entire follow-up was similar between groups (P = 1). Glycemia control perception, satisfaction with insulin treatment, and willingness to continue insulin use improved more in the liraglutide group.
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