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
NCT ID: NCT03499704
Last Updated: 2023-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
133 participants
INTERVENTIONAL
2020-02-11
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 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.
Pioglitazone + Alogliptin
Pioglitazone and Alogliptin FDC tablets
Metformin
Metformin tablets.
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 26.
Alogliptin
Alogliptin tablets.
Metformin
Metformin tablets.
Dapagliflozin
Dapagliflozin tablets.
Interventions
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Pioglitazone + Alogliptin
Pioglitazone and Alogliptin FDC tablets
Alogliptin
Alogliptin tablets.
Metformin
Metformin tablets.
Dapagliflozin
Dapagliflozin tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. The subject has been receiving a stable dose of DPP-4 inhibitor + metformin therapy with diet and exercise for ≥ 3 months prior to Randomization.
4. 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.
Exclusion Criteria
2. The subject has an active bladder cancer or a history of bladder cancer.
3. 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.
4. Has genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder, etc.
5. Has a history of alcohol abuse within 2 years prior to randomization.
19 Years
75 Years
ALL
No
Sponsors
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Celltrion Pharm, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Team
Role: STUDY_DIRECTOR
Celltrionpharm Inc.
Locations
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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
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
Kangbuk Samsung Hospital
Seoul, , South Korea
Yonsei University Health System Severance Hospital
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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Other Identifiers
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U1111-1207-8037
Identifier Type: OTHER
Identifier Source: secondary_id
Alogliptin-Pio-4001
Identifier Type: -
Identifier Source: org_study_id
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