METHODS: The ARTEMIS-DM was a 26-week, prospective, interventional, single-arm, phase IV study (NCT03760991). Adults with T2DM previously uncontrolled (glycated haemoglobin [HbA1c] 7.5-10%) on BI were switched to Gla-300. The primary endpoint was change in HbA1c from baseline to 26 weeks. Key secondary endpoints were changes in HbA1c (week 12), fasting plasma glucose (FPG), self-monitored plasma glucose (SMPG) and BI dose from baseline to week 26. The safety and tolerability of Gla-300 were also assessed.
RESULTS: A total of 372 (50% male) participants were included, with mean (standard deviation [SD]) age 60.9 (10.0) years, duration of diabetes 13.11 (7.48) years and baseline HbA1c 8.67 (0.77)% (71.22 [8.44] mmol/mol). A total of 222 (59.7%) participants were using insulin glargine 100 U/mL and 107 (28.8%) were using neutral protamine Hagedorn insulin as previous BI. There were clinically significant reductions in mean HbA1c (- 0.82%; primary endpoint), FPG and SMPG levels at week 26. With a pre-defined titration algorithm, mean Gla-300 dose increased from 27.48 U (0.35 U/kg) at baseline to 39.01 U (0.50 U/kg) at week 26. Hypoglycaemia events occurred in 20.4% of the participants; 1 (0.3%) participant had a severe hypoglycaemia event.
CONCLUSION: In people with T2DM uncontrolled on previous BI, switching to Gla-300 with optimal titration guided by an algorithm was associated with improved glycaemic control and low incidence of hypoglycaemia across multiple geographic regions.
GOV IDENTIFIER: NCT03760991.
MATERIALS AND METHODS: This hospital-based, case-control study involved randomly selected 176 pregnant and non-pregnant women attending the University of Abuja Teaching Hospital (UATH), Gwagwalada, Nigeria. Hemoglobin and hematocrit measurements were used to determine anemia incidence, while plasma protein, zinc levels and body mass index (BMI) were used to determine energy index status. Complete blood counts were analyzed using 5 parts-automatic hemo-analyzer, while plasma protein and zinc were analyzed using calorimetric method. Anemia and protein-energy malnutrition were defined using the World Health Organization (WHO) cut-off values.
RESULTS: The mean age of participants was 28.75 ± 5.22 years. Out of 176 participants, 7 (4%) were malnourished while 25% of the participants were anemic. Anemia was significantly associated with participants' occupation (p = 0.002), parity (p<0.001) and gestational age (p<0.001). Most hematological indices, plasma globulin, albumin, protein, and zinc levels were significantly different (p<0.001) among non-pregnant and pregnant women of the first, second and third trimesters.
CONCLUSION: The incidence of anemia and malnutrition was high among study participants. There is a need for improved nutritional intervention, increased awareness and strengthening of health systems in the area of maternal health in Nigeria.