INTRODUCTION: Liraglutide effectively controls blood glucose level and reduces body weight. The aim of this study was to compare the efficacy and safety of a biosimilar liraglutide (Melitide®; CinnaGen, Tehran, Iran) to the reference liraglutide (Victoza®; Novo Nordisk, Bagsvaerd, Denmark) in people with type 2 diabetes mellitus (T2DM). METHODS: In this phase 3 clinical noninferiority trial, adult patients with inadequately controlled T2DM and with hemoglobin A1C (HbA1C) levels of 7-10.5% on at least two oral glucose-lowering drugs with stable doses for at least 3 months were randomized to receive Melitide® (n = 150) or Victoza® (n = 150) 1.8 mg/day for 26 weeks. The primary outcome was assessment of the noninferiority of Melitide® to Victoza® in terms of change in HbA1C level with a prespecified margin of 0.4%. The secondary outcomes were the assessment of additional efficacy parameters (including the proportion of patients achieving HbA1C levels of < 7%), the incidence of adverse events, and immunogenicity. RESULTS: Of the 300 participants enrolled in this study, 235 were included in the per-protocol analysis (112 in the Melitide® group and 123 in the Victoza® group). The mean (standard deviation) changes in HbA1C were - 1.76% (1.22) in the Melitide® group and - 1.59% (1.31) in the Victoza® group. The upper limit of the 95% one-sided confidence interval (CI) of the mean difference between Melitide® and Victoza® in lowering HbA1C was lower than the predefined margin (mean difference - 0.18, 95% CI - 0.5 to 0.15). Similar findings were obtained with the intention-to-treat analysis. No statistically significant differences were observed between the two study arms regarding the proportion of patients achieving HbA1C < 7% (p = 0.210), other efficacy parameters (p > 0.05), and reported adverse events (p = 0.916). Furthermore, none of the patients developed anti-liraglutide antibodies. CONCLUSION: The biosimilar liraglutide (Melitide®) was noninferior in efficacy and comparable in safety when compared with the reference liraglutide. TRIAL REGISTRATION: NCT03421119.
BACKGROUND: Bronchiectasis is an abnormal and permanent dilatation of bronchi. Infection plays a major role in causing and perpetuating bronchiectasis, as reducing the microbial load and attendant mediators are cornerstone of therapy. Zinc, as an integral micronutrient is involved in the immune reactions including response to infection. In several previous studies, mild zinc deficiency has been described in many infectious diseases such as abscess, cellulitis, chronic diarrhea, pneumonia, tuberculosis (TB), etc. OBJECTIVES: The purpose of this study was to determine serum zinc level in a series of patients suffering from bronchiectasis and to compare it with healthy control group. PATIENTS AND MATERIALS: This analytical cross-sectional study was performed on thirty four patients with proven bronchiectasis and twenty nine healthy control subjects referred to Rasoul-e-Akram Hospital, Tehran, Iran, between March 2005 and March 2007. Serum concentration of the zinc was measured for all of the subjects and other information was completed according to their medical records. Both groups (case and control) were frequently matched regarding their age groups. RESULTS: Patients included 11 (32.4%) males and 23 (67.6%) females with the average age of 55.03 (SD = 17.06) yr. The mean level of serum zinc in the case and control groups were 94.06 (SD = 20/96) mcg/dl and 103.7 (SD = 11.96) mcg/dl, respectively. Independent T-test analysis showed that serum zinc concentration in the case group of bronchiectasis patients was significantly lower than control group (P = 0.02). CONCLUSIONS: The results of our study show that serum zinc level in bronchiectasis patients was lower than the control group and the difference was statistically significant. It seems that the use of zinc supplement can reduce progression of the infectious disease regarding its role in improving the immune system reactions and some unknown mechanisms. Therefore, prophylactic and therapeutic use of zinc must be evaluated in further trials.
