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Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial
by
Seo, Hyun-Ae
, Jung, Hye Seung
, Heo, Ji Hye
, Hong, Eun-Gyoung
, Han, Kyung Ah
, Yu, Jae Myung
, Hong, Jun Hwa
, Cha, Bong-Soo
in
Adult
/ Aged
/ Analysis of covariance
/ Benzhydryl Compounds - administration & dosage
/ Benzhydryl Compounds - therapeutic use
/ Blood Glucose - analysis
/ Blood Glucose - drug effects
/ cardiovascular diseases
/ Clinical medicine
/ Clinical trials
/ Diabetes
/ diabetes mellitus, type 2
/ Diabetes Mellitus, Type 2 - blood
/ Diabetes Mellitus, Type 2 - drug therapy
/ Double-Blind Method
/ Drug dosages
/ Drug Therapy, Combination
/ Female
/ Glucosides - administration & dosage
/ Glucosides - therapeutic use
/ Glycated Hemoglobin - analysis
/ Humans
/ Hypoglycemic Agents - administration & dosage
/ Hypoglycemic Agents - therapeutic use
/ Insulin resistance
/ Male
/ Metformin - administration & dosage
/ Metformin - therapeutic use
/ Middle Aged
/ Original
/ Pioglitazone - administration & dosage
/ Pioglitazone - therapeutic use
/ sodium-glucose transporter 2 inhibitors
/ thiazolidinediones
/ Treatment Outcome
/ 내과학
2024
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Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial
by
Seo, Hyun-Ae
, Jung, Hye Seung
, Heo, Ji Hye
, Hong, Eun-Gyoung
, Han, Kyung Ah
, Yu, Jae Myung
, Hong, Jun Hwa
, Cha, Bong-Soo
in
Adult
/ Aged
/ Analysis of covariance
/ Benzhydryl Compounds - administration & dosage
/ Benzhydryl Compounds - therapeutic use
/ Blood Glucose - analysis
/ Blood Glucose - drug effects
/ cardiovascular diseases
/ Clinical medicine
/ Clinical trials
/ Diabetes
/ diabetes mellitus, type 2
/ Diabetes Mellitus, Type 2 - blood
/ Diabetes Mellitus, Type 2 - drug therapy
/ Double-Blind Method
/ Drug dosages
/ Drug Therapy, Combination
/ Female
/ Glucosides - administration & dosage
/ Glucosides - therapeutic use
/ Glycated Hemoglobin - analysis
/ Humans
/ Hypoglycemic Agents - administration & dosage
/ Hypoglycemic Agents - therapeutic use
/ Insulin resistance
/ Male
/ Metformin - administration & dosage
/ Metformin - therapeutic use
/ Middle Aged
/ Original
/ Pioglitazone - administration & dosage
/ Pioglitazone - therapeutic use
/ sodium-glucose transporter 2 inhibitors
/ thiazolidinediones
/ Treatment Outcome
/ 내과학
2024
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Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial
by
Seo, Hyun-Ae
, Jung, Hye Seung
, Heo, Ji Hye
, Hong, Eun-Gyoung
, Han, Kyung Ah
, Yu, Jae Myung
, Hong, Jun Hwa
, Cha, Bong-Soo
in
Adult
/ Aged
/ Analysis of covariance
/ Benzhydryl Compounds - administration & dosage
/ Benzhydryl Compounds - therapeutic use
/ Blood Glucose - analysis
/ Blood Glucose - drug effects
/ cardiovascular diseases
/ Clinical medicine
/ Clinical trials
/ Diabetes
/ diabetes mellitus, type 2
/ Diabetes Mellitus, Type 2 - blood
/ Diabetes Mellitus, Type 2 - drug therapy
/ Double-Blind Method
/ Drug dosages
/ Drug Therapy, Combination
/ Female
/ Glucosides - administration & dosage
/ Glucosides - therapeutic use
/ Glycated Hemoglobin - analysis
/ Humans
/ Hypoglycemic Agents - administration & dosage
/ Hypoglycemic Agents - therapeutic use
/ Insulin resistance
/ Male
/ Metformin - administration & dosage
/ Metformin - therapeutic use
/ Middle Aged
/ Original
/ Pioglitazone - administration & dosage
/ Pioglitazone - therapeutic use
/ sodium-glucose transporter 2 inhibitors
/ thiazolidinediones
/ Treatment Outcome
/ 내과학
2024
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Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial
Journal Article
Pioglitazone as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial
2024
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Overview
Background: This study assessed the efficacy and safety of triple therapy with pioglitazone 15 mg add-on versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and dapagliflozin.Methods: In this multicenter, double-blind, randomized, phase 3 study, patients with T2DM with an inadequate response to treatment with metformin (≥1,000 mg/day) plus dapagliflozin (10 mg/day) were randomized to receive additional pioglitazone 15 mg/day (n=125) or placebo (n=125) for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin (HbA1c) levels from baseline to week 24 (ClinicalTrials.gov identifier: NCT05101135).Results: At week 24, the adjusted mean change from baseline in HbA1c level compared with placebo was significantly greater with pioglitazone treatment (–0.47%; 95% confidence interval, –0.61 to –0.33; P<0.0001). A greater proportion of patients achieved HbA1c <7% or <6.5% at week 24 with pioglitazone compared to placebo as add-on to 10 mg dapagliflozin and metformin (56.8% vs. 28% for HbA1c <7%, and 23.2% vs. 9.6% for HbA1c <6.5%; P<0.0001 for all). The addition of pioglitazone also significantly improved triglyceride, highdensity lipoprotein cholesterol levels, and homeostatic model assessment of insulin resistance levels, while placebo did not. The incidence of treatment-emergent adverse events was similar between the groups, and the incidence of fluid retention-related side effects by pioglitazone was low (1.5%).Conclusion: Triple therapy with the addition of 15 mg/day of pioglitazone to dapagliflozin plus metformin was well tolerated and produced significant improvements in HbA1c in patients with T2DM inadequately controlled with dapagliflozin plus metformin.
Publisher
Korean Diabetes Association / Daehan Dangnyobyeong Hakoe,Korean Diabetes Association,대한당뇨병학회
Subject
/ Aged
/ Benzhydryl Compounds - administration & dosage
/ Benzhydryl Compounds - therapeutic use
/ Blood Glucose - drug effects
/ Diabetes
/ Diabetes Mellitus, Type 2 - blood
/ Diabetes Mellitus, Type 2 - drug therapy
/ Female
/ Glucosides - administration & dosage
/ Glucosides - therapeutic use
/ Glycated Hemoglobin - analysis
/ Humans
/ Hypoglycemic Agents - administration & dosage
/ Hypoglycemic Agents - therapeutic use
/ Male
/ Metformin - administration & dosage
/ Original
/ Pioglitazone - administration & dosage
/ Pioglitazone - therapeutic use
/ sodium-glucose transporter 2 inhibitors
/ 내과학
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