A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy
EPIDOTE
A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Dipeptidyl Peptidase-4 Inhibitor and Metformin Therapy
2 other identifiers
interventional
133
1 country
15
Brief Summary
The purpose of this study is to assess the pioglitazone plus alogliptin plus metformin is non-inferior to dapagliflozin plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c) change from baseline at Week 26.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Feb 2020
Longer than P75 for phase_4 diabetes-mellitus-type-2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2018
CompletedStudy Start
First participant enrolled
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2024
CompletedMarch 18, 2026
February 1, 2025
3.9 years
April 9, 2018
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change from Baseline in HbA1c at Week 26
Baseline and Week 26
Secondary Outcomes (3)
Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 26
Baseline and Week 26
Mean Change from Baseline in Serum Lipids at Week 26
Baseline and Week 26
Number of Participants who Achieved an HbA1c Goal Target of Less than (<) 6.5 Percent (%) at Week 26
Week 26
Study Arms (2)
Pioglitazone + Alogliptin + Metformin (PAM)
EXPERIMENTALPioglitazone 15 milligram (mg) and alogliptin 25 mg in fixed dose combination (FDC) tablet (SYR-322-4833), orally once daily and metformin greater than or equal to (\>=) 500 mg, tablet, orally, twice a day for up to 26 weeks. At Week 12, if participants has HbA1c \>=7.5%, pioglitazone dose will be titrated up to 30 mg based on investigator's opinion and up-titrated dose will be maintained up to Week 26.
Dapagliflozin + Alogliptin + Metformin (DAM)
ACTIVE COMPARATORDapagliflozin 10 mg, tablet, orally, once daily with alogliptin 25 mg, tablet, orally, once daily, and metformin \>=500 mg, tablet, orally, twice a day, for up to Week 26.
Interventions
Metformin tablets.
Pioglitazone and Alogliptin FDC tablets
Eligibility Criteria
You may qualify if:
- The subject is a regular outpatient with an has a historical diagnosis of type 2 diabetes.
- The subject has metabolic syndrome as jointly defined by the International Diabetes Federation (IDF); National Heart, Lung, and Blood Institute (NHLBI) / American Heart Association (AHA); and International Association for the Study of Obesity (IASO). If any 3 of the following 5 risk factors are present, metabolic syndrome can be considered:
- High waist circumference: male ≥ 90 cm, female ≥ 85 cm.
- High TGs (drug treatment for high TGs is an alternate indicator): ≥ 150 mg/dL (1.7 mmol/L).
- Low HDL-C (drug treatment for low HDL-C is an alternate indicator): \< 40 mg/dL(1.0 mmol/L) in males, \< 50 mg/dL (1.3 mmol/L) in females.
- High blood pressure (antihypertensive drug treatment in a subject with a history of hypertension is an alternate indicator): Systolic ≥ 130 mmHg and/or diastolic ≥ 85 mmHg.
- High fasting glucose (drug treatment of high glucose is an alternate indicator): ≥ 100 mg/dL.
- The subject has been receiving a stable dose of DPP-4 inhibitor + metformin therapy with diet and exercise for ≥ 3 months prior to Randomization.
- The subject has a HbA1c value between 7.0 and 11% inclusively within 28 days of Randomization via central laboratory test or after run-in period for 4 weeks via central laboratory test.
You may not qualify if:
- The subject has type 1 diabetes, diabetic ketoacidosis, diabetic coma or diabetic precoma.
- The subject has an active bladder cancer or a history of bladder cancer.
- The use of any medications ie, oral or systemically injected glucocorticoids (including intra-articular injection), weight-loss drugs, insulin or other anti-diabetic drugs except DPP-4 inhibitor and metformin, within 3 months prior to randomization. Strong Cytochrome P450 2C8 (CYP2C8) inhibitors (eg, gemfibrozil, montelukast, quercetin, phenelzine) and CYP2C8 inducers (eg, rifampin) that in the opinion of the Investigator or Sponsor require treatment contraindicated during the study. The diuretics, angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) -inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs) are to be used per product label with close monitoring under Investigator's supervision.
- Has genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder, etc.
- Has a history of alcohol abuse within 2 years prior to randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
The Catholic University of Korea, Bucheon, St. Marys Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, ST. Vincents Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
YeungNam University Hospital
Daegu, 42415, South Korea
Daejeon Eulji Medical Center, Eulji University
Daejeon, 35233, South Korea
Chosun University Hospital
Gwangju, 61453, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Yonsei University Health System Severance Hospital
Seoul, 03722, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Team
Celltrionpharm Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2018
First Posted
April 17, 2018
Study Start
February 11, 2020
Primary Completion
January 2, 2024
Study Completion
January 16, 2024
Last Updated
March 18, 2026
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
Celltrionpharm makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), and an opportunity for the primary publication of the research and final report development has been allowed. To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.