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. * Pioglitazone 15 mg + Alogliptin 25 mg + Metformin \>=500 mg * Dapagliflozin 10 mg + Alogliptin 25 mg + Metformin \>=500 mg 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Pioglitazone and Alogliptin FDC tablets
Alogliptin tablets.
Metformin tablets.
The Catholic University of Korea, Bucheon, St. Marys Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
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
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Dapagliflozin tablets.
The Catholic University of Korea, ST. Vincents Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
YeungNam University Hospital
Daegu, South Korea
Daejeon Eulji Medical Center, Eulji University
Daejeon, South Korea
Chosun University Hospital
Gwangju, South Korea
Korea University Anam Hospital
Seoul, South Korea
...and 5 more locations