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Efficacy and Safety of Alogliptin-Pioglitazone Combination for Type 2 Diabetes Mellitus Poorly Controlled with Metformin: A Multicenter, Double-Blind Randomized Trial.
Park, Ji-Yeon; Lee, Joonyub; Choi, Yoon-Hee; Min, Kyung Wan; Han, Kyung Ah; Ahn, Kyu Jeung; Lim, Soo; Kim, Young-Hyun; Ahn, Chul Woo; Choi, Kyung Mook; Yoon, Kun-Ho.
Afiliación
  • Park JY; Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • Lee J; Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • Choi YH; Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • Min KW; MedicalExcellence Inc., Seoul, Korea.
  • Han KA; Division of Endocrinology and Metabolism, Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.
  • Ahn KJ; Division of Endocrinology and Metabolism, Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.
  • Lim S; Division of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.
  • Kim YH; Division of Endocrinology and Metabolism, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
  • Ahn CW; Division of Endocrinology and Metabolism, Bundang Jesaeng Hospital, Seongnam, Korea.
  • Choi KM; Division of Endocrinology and Metabolism, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • Yoon KH; Department of Endocrinology, Korea University Guro Hospital, Seoul, Korea.
Diabetes Metab J ; 48(5): 915-928, 2024 Sep.
Article en En | MEDLINE | ID: mdl-38650099
ABSTRACT
BACKGRUOUND Guidelines for switching to triple combination therapy directly after monotherapy failure are limited. This study investigated the efficacy, long-term sustainability, and safety of either mono or dual add-on therapy using alogliptin and pioglitazone for patients with type 2 diabetes mellitus (T2DM) who did not achieve their target glycemic range with metformin monotherapy.

METHODS:

The Practical Evidence of Antidiabetic Combination Therapy in Korea (PEAK) was a multicenter, placebo-controlled, double-blind, randomized trial. A total of 214 participants were randomized to receive alogliptin+pioglitazone (Alo+Pio group, n=70), alogliptin (Alo group, n=75), or pioglitazone (Pio group, n=69). The primary outcome was the difference in glycosylated hemoglobin (HbA1c) levels between the three groups at baseline to 24 weeks. For durability, the achievement of HbA1c levels <7% and <6.5% was compared in each group. The number of adverse events was investigated for safety.

RESULTS:

After 24 weeks of treatment, the change of HbA1c in the Alo+Pio, Alo, and Pio groups were -1.38%±0.08%, -1.03%±0.08%, and -0.84%±0.08%, respectively. The Alo+Pio group had significantly lower HbA1c levels than the other groups (P=0.0063, P<0.0001) and had a higher proportion of patients with target HbA1c achievement. In addition, insulin sensitivity and ß-cell function, lipid profiles, and other metabolic indicators were also improved. There were no significant safety issues in patients treated with triple combination therapy.

CONCLUSION:

Early combination triple therapy showed better efficacy and durability than the single add-on (dual) therapy. Therefore, combination therapy with metformin, alogliptin, and pioglitazone is a valuable early treatment option for T2DM poorly controlled with metformin monotherapy.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piperidinas / Uracilo / Glucemia / Hemoglobina Glucada / Diabetes Mellitus Tipo 2 / Quimioterapia Combinada / Pioglitazona / Hipoglucemiantes / Metformina Límite: Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Diabetes Metab J Año: 2024 Tipo del documento: Article Pais de publicación: Corea del Sur
Texto completo
Añadir a Mi BVS
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XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Piperidinas / Uracilo / Glucemia / Hemoglobina Glucada / Diabetes Mellitus Tipo 2 / Quimioterapia Combinada / Pioglitazona / Hipoglucemiantes / Metformina Límite: Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: Diabetes Metab J Año: 2024 Tipo del documento: Article Pais de publicación: Corea del Sur