Addition of sitagliptin to ongoing metformin improved metabolic profile and pancreatic function via normalizing inflammatory cytokines' levels in patients with type 2 diabetes, a randomized double-blinded clinical trial
Abstract
Background: DPP-4 inhibitors have anti-diabetic effects in T2DM, but their impact on pancreatic function and underlying mechanisms remain unclear. This study aimed to evaluate the effects of sitagliptin on pancreatic function and glucose regulation, focusing on the roles of IL-18, IL-1, and IL-6 in T2DM patients.
Research design and methods: A 12-week clinical trial included 60 T2DM patients, randomly assigned to receive either metformin (2000 mg/day) or sitagliptin + metformin (100 mg and 2000 mg/day, respectively). Metabolic indices (fasting blood sugar [FBS], hemoglobin A1c [HbA1c], triglycerides [TG], cholesterol [Chol]), biochemical parameters, and vitamin D3 levels were measured at baseline and after 12 weeks. IL-1, IL-6, IL-18, and insulin levels were also evaluated.
Results: Sitagliptin + metformin group showed a greater reduction in FBS (p = 0.005), blood sugar (p = 0.011), and improvements in cholesterol (p = 0.001), TG-G index (p = 0.017), and pancreatic efficiency (p = 0.003) compared to metformin alone. Reductions in IL-1, IL-6, and IL-18 levels were observed (p = 0.00). Sitagliptin significantly reduced IL-1 levels (p = 0.034) compared to metformin alone. No significant changes were seen in HbA1c or vitamin D3.
Conclusion: Sitagliptin plus metformin improved pancreatic function, glucose homeostasis, and reduced IL-1, IL-6, and IL-18 levels in T2DM patients with inadequate glycemic control on metformin alone, offering cardiovascular benefits (Clinical Trial…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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