A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by Alogliptin and Metformin Therapy (EPIDOTE)
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|ClinicalTrials.gov Identifier: NCT03499704|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Pioglitazone + Alogliptin Drug: Alogliptin Drug: Metformin Drug: Dapagliflozin||Phase 4|
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 232 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 55 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 (Clinical Trial)|
|Estimated Enrollment :||232 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Alogliptin and Metformin Therapy|
|Actual Study Start Date :||February 11, 2020|
|Estimated Primary Completion Date :||January 29, 2022|
|Estimated Study Completion Date :||February 12, 2022|
Experimental: Pioglitazone + Alogliptin + Metformin (PAM)
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 52 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 52.
Drug: Pioglitazone + Alogliptin
Pioglitazone and Alogliptin FDC tablets
Other Name: SYR-322-4833
Active Comparator: Dapagliflozin + Alogliptin + Metformin (DAM)
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 52.
- Mean Change from Baseline in HbA1c at Week 52 [ Time Frame: Baseline and Week 52 ]
- Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 52 [ Time Frame: Baseline and Week 52 ]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.
- Mean Change from Baseline in Serum Lipids at Week 52 [ Time Frame: Baseline and Week 52 ]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.
- Number of Participants who Achieved an HbA1c Goal Target of Less than (<) 6.5 Percent (%) at Week 52 [ Time Frame: Week 52 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499704
|Contact: Takeda Study Registration Call Centeremail@example.com|
|Korea, Republic of|
|The Catholic University of Korea, Bucheon, St. Marys Hospital||Not yet recruiting|
|Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647|
|Inje University Ilsan Paik Hospital||Recruiting|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 10380|
|Seoul National University Bundang Hospital||Recruiting|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620|
|The Catholic University of Korea, ST. Vincents Hospital||Not yet recruiting|
|Suwon-si, Gyeonggi-do, Korea, Republic of, 16247|
|Ajou University Hospital||Not yet recruiting|
|Suwon, Gyeonggi-do, Korea, Republic of, 16499|
|Pusan National University Hospital||Not yet recruiting|
|Busan, Korea, Republic of, 49241|
|YeungNam University Hospital||Recruiting|
|Daegu, Korea, Republic of, 42415|
|Daejeon Eulji Medical Center, Eulji University||Recruiting|
|Daejeon, Korea, Republic of, 35233|
|Chosun University Hospital||Not yet recruiting|
|Gwangju, Korea, Republic of, 61453|
|Korea University Anam Hospital||Not yet recruiting|
|Seoul, Korea, Republic of, 02841|
|Kangbuk Samsung Hospital||Recruiting|
|Seoul, Korea, Republic of, 03181|
|Yonsei University Health System Severance Hospital||Recruiting|
|Seoul, Korea, Republic of, 03722|
|Kyung Hee University Hospital at Gangdong||Recruiting|
|Seoul, Korea, Republic of, 05278|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 06351|
|Ulsan University Hospital||Recruiting|
|Ulsan, Korea, Republic of, 44033|
|Study Director:||Medical Director||Takeda|