Diabetes Metab J.  2022 Sep;46(5):689-700. 10.4093/dmj.2021.0183.

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

• Kim HJ
• Jeong IK
• Hur KY
• Kim SK
• Noh JH
• Chun SW
• Kang ES
• Rhee EJ
• Choi SH

• KMID: 2533638
• DOI: http://doi.org/10.4093/dmj.2021.0183

Abstract

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.

Keyword

Alogliptin; Diabetes mellitus, type 2; Glimepiride; Glycemic control; Pioglitazone

Figure

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  Fig. 1. Study flowchart.

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  Fig. 2. Adjusted mean changes in (A) glycosylated hemoglobin (HbA1c) and (B) fasting plasma glucose from baseline at 12 weeks and 24 weeks during glimepiride (GLIM), alogliptin (ALO), or aloglipitin-pioglitazone (ALO-PIO) combination therapy. Error bar means and standard error of adjusted means. aP value <0.05 in analysis of covariance (ANCOVA).

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