Abstract
The goal of the study was to evaluate the effect of adding linagliptin to metformin and lifestyle on glucose levels and pancreatic β-cell function in patients with persistent impaired glucose tolerance (IGT) after 12 months of metformin and lifestyle. A single center parallel double-blind randomized clinical trial with 6 months of follow-up was performed in patients with persistent IGT after 12 months of treatment with metformin and lifestyle; patients were randomized to continue with metformin 850 mg twice daily (M group, n = 12) or linagliptin/metformin 2.5/850 mg twice daily (LM group, n = 19). Anthropometric measurements were obtained by standard methods and by bioelectrical impedance; glucose was measured by dry chemistry, insulin by chemiluminescence, and pancreatic β-cell function was calculated with the disposition index using glucose and insulin values during oral glucose tolerance test (OGTT) and adjusting by insulin sensitivity. The main outcomes were glucose levels during OGTT and pancreatic β-cell function. Patients in the LM group had a reduction in weight (−1.7 ± 0.6, p < 0.05) and body mass index (BMI, −0.67 ± 0.2, p < 0.05). Glucose levels significantly improved in LM group with a greater reduction in the area under the glucose curve during OGTT (AUCGluc0_120min) as compared to the M group (−4425 ± 871 vs −1116 ± 1104 mg/dl/120 min, p < 0.001). Pancreatic β-cell function measured with the disposition index, improved only in LM group (2.3 ± 0.23 vs 1.7 ± 0.27, p 0.001); these improvements persisted after controlling for OGTT glucose levels. The differences in pancreatic β-cell function persisted also after pairing groups for basal AUCGluc0_120min. The addition of linagliptin to patients with persistent IGT after 12 months of treatment with metformin and lifestyle, improved glucose levels during OGTT and pancreatic β-cell function after 6 months of treatment.Trial registration: Clinicaltrials.gov with the ID number NCT04088461
Highlights
The goal of the study was to evaluate the effect of adding linagliptin to metformin and lifestyle on glucose levels and pancreatic β-cell function in patients with persistent impaired glucose tolerance (IGT) after 12 months of metformin and lifestyle
Different pathophysiological abnormalities coexist in individuals with prediabetes, including pancreatic β-cell dysfunction, insulin resistance, reduced incretin effect and lipotoxicity, among others; with pancreatic β-cell dysfunction being a key factor involved in the progression of prediabetes to T2D12–22
Current guidelines recommend the use of metformin as a pharmacological treatment in patients with prediabetes together with lifestyle changes, metformin reduces the risk of Type 2 diabetes (T2D) only by 31%30
Summary
The goal of the study was to evaluate the effect of adding linagliptin to metformin and lifestyle on glucose levels and pancreatic β-cell function in patients with persistent impaired glucose tolerance (IGT) after 12 months of metformin and lifestyle. The addition of linagliptin to patients with persistent IGT after 12 months of treatment with metformin and lifestyle, improved glucose levels during OGTT and pancreatic β-cell function after 6 months of treatment. Linagliptin is a DPP-IV inhibitor for T2D treatment, which is metabolized by the liver 37,38 It improves beta cell function and reduces the risk of T2D onset in patients with prediabetes, when combined with metformin and a lifestyle modification p rogram[39]. Considering these differential and complementary mechanism of action, we hypothesize that adding linagliptin to patients with prediabetes with scarce response to metformin would improve glucose metabolism and pancreatic β-cell function
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