Diabetes Trial Files: The Intense Simplified Strategy for T2DM, Semaglutide in Obesity + Osteoarthritis, and Liraglutide for Children with Obesity
Intense simplified strategy for newly diagnosed type 2 diabetes in patients with severe hyperglycaemia
Liu L et al. BMJ (October 2024)
Bottom Line: This was a multicentre, open label, randomised trial conducted in 15 hospitals in China between December 2017 and December 2020. The study included 412 patients with newly diagnosed type 2 diabetes and significant hyperglycaemia. All participants initially received short term intensive insulin therapy (SIIT) for 2-3 weeks, followed by either linagliptin 5 mg/day, metformin 1000 mg/day, combination of both, or lifestyle modification alone (control) for 48 weeks. The primary outcome was the percentage of participants achieving HbA1c <7.0% at week 48 after SIIT. The results showed that 80% of patients in the linagliptin plus metformin group achieved the primary outcome, compared to 60% in the control group. The combination of linagliptin and metformin was found to be the most effective in improving glycaemic control and β cell function. All treatments were well tolerated. In conclusion, the intense simplified strategy using subsequent oral therapies post-SIIT offers a promising direction for decision making in the clinical management of type 2 diabetes mellitus.
Once-Weekly Semaglutide in Persons with Obesity and Knee Osteoarthritis
Bliddal H et al. NEJM (October 2024)
Bottom Line: This 68-week, double-blind, randomized, placebo-controlled trial evaluated the effects of once-weekly subcutaneous semaglutide (2.4 mg) on weight and pain in participants with obesity and knee osteoarthritis. A total of 407 participants were enrolled and the primary outcomes were percentage change in body weight and change in WOMAC pain score at week 68. Results showed a -13.7% change in body weight and -41.7 points change in WOMAC pain score in the semaglutide group compared to -3.2% and -27.5 points in the placebo group, respectively. Participants in the semaglutide group also had a greater improvement in SF-36 physical-function score. The incidence of serious adverse events was similar in both groups. Treatment with semaglutide resulted in significantly greater reductions in body weight and pain related to knee osteoarthritis compared to placebo.
Liraglutide for Children 6 to <12 Years of Age with Obesity
Fox CK et al. NEJM (September 2024)
Bottom Line: This phase 3a trial, funded by Novo Nordisk, aimed to evaluate the safety and efficacy of liraglutide in children (6 to <12 years of age) with obesity. Participants were randomly assigned to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or placebo, plus lifestyle interventions for a 56-week treatment period and a 26-week follow-up period. The primary outcome was the percentage change in BMI at week 56. A total of 82 participants underwent randomization, with 56 in the liraglutide group and 26 in the placebo group. The results showed a significant reduction in BMI in the liraglutide group compared to the placebo group, with a mean percentage change of -5.8% and 1.6%, respectively. Adverse events were reported in both groups, with gastrointestinal adverse events being more common in the liraglutide group. In conclusion, treatment with liraglutide for 56 weeks plus lifestyle interventions resulted in a greater reduction in BMI in children with obesity.
Diabetes Trial Files Issue #DIA-2024-05
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