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Comparison of Efficacy of Glimepiride, Alogliptin, and Alogliptin-Pioglitazone as the Initial Periods of Therapy in Patients with Poorly Controlled Type 2 Diabetes Mellitus: An Open-Label, Multicenter, Randomized, Controlled Study

 Hae Jin Kim  ;  In Kyung Jeong  ;  Kyu Yeon Hur  ;  Soo-Kyung Kim  ;  Jung Hyun Noh  ;  Sung Wan Chun  ;  Eun Seok Kang  ;  Eun-Jung Rhee  ;  Sung Hee Choi 
 DIABETES & METABOLISM JOURNAL, Vol.46(5) : 689-700, 2022-09 
Journal Title
Issue Date
Autoimmune Diseases* ; Blood Glucose ; Blood Glucose Self-Monitoring ; Cholesterol ; Diabetes Mellitus, Type 2* ; Drug Therapy, Combination ; Glycated Hemoglobin ; Humans ; Hypoglycemic Agents / adverse effects ; Lipids ; Lipoproteins, HDL ; Metformin* / therapeutic use ; Pioglitazone / therapeutic use ; Piperidines ; Sulfonylurea Compounds ; Treatment Outcome ; Uracil / analogs & derivatives
Alogliptin ; Diabetes mellitus, type 2 ; Glimepiride ; Glycemic control ; Pioglitazone
Background: The choice of an optimal oral hypoglycemic agent in the initial treatment periods for type 2 diabetes mellitus (T2DM) patients remains difficult and deliberate. We compared the efficacy and safety of glimepiride (GLIM), alogliptin (ALO), and alogliptin-pioglitazone (ALO-PIO) in poorly controlled T2DM patients with drug-naïve or metformin failure.

Methods: In this three-arm, multicenter, open-label, randomized, controlled trial, poorly controlled T2DM patients were randomized to receive GLIM (n=35), ALO (n=31), or ALO-PIO (n=33) therapy for 24 weeks. The primary endpoint was change in the mean glycosylated hemoglobin (HbA1c) levels at week 24 from baseline. Secondary endpoints were changes in HbA1c level at week 12 from baseline, fasting plasma glucose (FPG) levels, lipid profiles at weeks 12 and 24, and parameters of glycemic variability, assessed by continuous glucose monitoring for 24 weeks.

Results: At weeks 12 and 24, the ALO-PIO group showed significant reduction in HbA1c levels compared to the ALO group (-0.96%±0.17% vs. -0.37%±0.17% at week 12; -1.13%±0.19% vs. -0.18%±0.2% at week 24). The ALO-PIO therapy caused greater reduction in FPG levels and significant increase in high-density lipoprotein cholesterol levels at weeks 12 and 24 than the ALO therapy. Compared to low-dose GLIM therapy, ALO-PIO therapy showed greater improvement in glycemic variability. The adverse events were similar among the three arms.

Conclusion: ALO-PIO combination therapy during the early period exerts better glycemic control than ALO monotherapy and excellency in glycemic variability than low-dose sulfonylurea therapy in uncontrolled, drug-naïve or metformin failed T2DM patients.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kang, Eun Seok(강은석) ORCID logo https://orcid.org/0000-0002-0364-4675
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