Diabetes Metab J.  2021 Sep;45(5):675-683. 10.4093/dmj.2020.0107.

Efficacy and Safety of Treatment with Quadruple Oral Hypoglycemic Agents in Uncontrolled Type 2 Diabetes Mellitus: A Multi-Center, Retrospective, Observational Study

• Moon JS
• Suh S
• Kim SS
• Jin HY
• Kim JM
• Jang MH
• Lee KA
• Lee JH
• Chung SM
• Lyu YS
• Kim JH
• Kim SY
• Jang JE
• Kim TN
• Kim SW
• Jeon E
• Cho NH
• Kim MK
• Kim HS
• Nam-Goong IS
• Kim ES
• Chung JO
• Cho DH
• Lee CW
• Kim YI
• Chung DJ
• Won KC
• Kim IJ
• Park TS
• Kim DK
• Shon H

• KMID: 2520850
• DOI: http://doi.org/10.4093/dmj.2020.0107

Abstract

Only few studies have shown the efficacy and safety of glucose-control strategies using the quadruple drug combination. Therefore, the aim of the present study was to investigate the usefulness of the quadruple combination therapy with oral hypoglycemic agents (OHAs) in patients with uncontrolled type 2 diabetes mellitus (T2DM).

From March 2014 to December 2018, data of patients with T2DM, who were treated with quadruple hypoglycemic medications for over 12 months in 11 hospitals in South Korea, were reviewed retrospectively. We compared glycosylated hemoglobin (HbA1c) levels before and 12 months after quadruple treatment with OHAs. The safety, maintenance rate, and therapeutic patterns after failure of the quadruple therapy were also evaluated.

In total, 357 patients were enrolled for quadruple OHA therapy, and the baseline HbA1c level was 9.0%±1.3% (74.9±14.1 mmol/mol). After 12 months, 270 patients (75.6%) adhered to the quadruple therapy and HbA1c was significantly reduced from 8.9%±1.2% to 7.8%±1.3% (mean change, −1.1%±1.2%; P<0.001). The number of patients with HbA1c <7% increased significantly from 5 to 68 (P<0.005). In addition, lipid profiles and liver enzyme levels were also improved whereas no changes in body weight. There was no significant safety issue in patients treated with quadruple OHA therapy.

This study shows the therapeutic efficacy of the quadruple OHA regimen T2DM and demonstrates that it can be an option for the management of T2DM patients who cannot use insulin or reject injectable therapy.

Keyword

Diabetes mellitus, type 2; Drug therapy, combination; Hypoglycemic agents; Injections; Insulin

Figure

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  Fig. 1 Efficacy of quadruple combination during study period. (A) Change in glycosylated hemoglobin (HbA1c, %) at baseline and at 12 months. (B) The proportion of subjects achieving HbA1c <7.0% (<53 mmol/mol). aP<0.001.

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