A Phase 4 interventional study of Pioglitazone + Alogliptin and Alogliptin in Diabetes Mellitus, Type 2, sponsored by Celltrion Pharm, Inc.. Completed at 15 sites in South Korea. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Celltrion Pharm, Inc. · Phase 4, Interventional, and Treatment
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.
The drug being tested in this study is Alogliptin Benzoate and Pioglitazone Hydrochloride FDC. This study will assess the efficacy of pioglitazone or dapagliflozin in participants with type 2 diabetes mellitus.
The study will enroll approximately 156 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups.
Based on investigators opinion at Week 12, if participant has HbA1c >=7.5%, dose of pioglitazone can be titrated up to 30 mg.
This multi-center trial will be conducted in Republic of Korea. The overall time to participate in this study is up to 36 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after their last dose of drug for a follow-up assessment.
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:
Exclusion Criteria:
Pioglitazone 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.
Drug: Pioglitazone + Alogliptin · Drug: Metformin
Dapagliflozin 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.
Drug: Alogliptin · Drug: Metformin · Drug: Dapagliflozin
Pioglitazone and Alogliptin FDC tablets
Also known as: SYR-322-4833
Alogliptin tablets.
Metformin tablets.
Dapagliflozin tablets.
Mean Change from Baseline in HbA1c at Week 26
Time frame: Baseline and Week 26
Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 26
HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR equal to (=) fasting insulin (micro unit per milliliter \[mcU/mL\])\*fasting glucose (millimole per milliliter \[mmol/mL\])/22.5. A higher number indicates a greater insulin resistance.
Time frame: Baseline and Week 26
Mean Change from Baseline in Serum Lipids at Week 26
The change from baseline in serum lipids (Total Cholesterol \[TC\], Low-density Lipoprotein Cholesterol \[LDL-C\], High-density Lipoprotein Cholesterol \[HDL-C\], Triglycerides \[TGs\]) will be analyzed using mixed model repeated measures (MMRM) model.
Time frame: Baseline and Week 26
Number of Participants who Achieved an HbA1c Goal Target of Less than (<) 6.5 Percent (%) at Week 26
Time frame: Week 26
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Celltrion Pharm, Inc.