Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
NCT ID: NCT04170998
Last Updated: 2021-12-10
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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COMPLETED
PHASE3
283 participants
INTERVENTIONAL
2020-01-02
2021-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Evogliptin 5mg group
Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Evogliptin 5mg
Participants receive Evogliptin 5mg orally once a day
Dapagliflozin 10mg
Participants receive Dapagliflozin orally once a day
Metformin ≥ 1000mg
Metformin are administered at the same dose and formulation.
Evogliptin Placebo group
Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d
Evogliptin Placebo
Participants receive placebo to match Evogliptin 5mg orally once a day
Dapagliflozin 10mg
Participants receive Dapagliflozin orally once a day
Metformin ≥ 1000mg
Metformin are administered at the same dose and formulation.
Interventions
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Evogliptin 5mg
Participants receive Evogliptin 5mg orally once a day
Evogliptin Placebo
Participants receive placebo to match Evogliptin 5mg orally once a day
Dapagliflozin 10mg
Participants receive Dapagliflozin orally once a day
Metformin ≥ 1000mg
Metformin are administered at the same dose and formulation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy
1. Subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit
2. Subjects who are receiving metformin ≥ 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit
* Subjects with 7.0%≤HbA1c≤10.5% at screening visit
* Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
* Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit
Exclusion Criteria
* patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
* Patients with severe infectious disease or severe traumatic systemic disorders
* End stage renal disease or dialysis patients
* Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies
19 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Seoul St, Mary's Hospital,The Catholic University of Korea
Seoul, , South Korea
Countries
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References
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Moon JS, Park IR, Kim HJ, Chung CH, Won KC, Han KA, Park CY, Won JC, Kim DJ, Koh GP, Kim ES, Yu JM, Hong EG, Lee CB, Yoon KH. Efficacy and Safety of Evogliptin Add-on Therapy to Dapagliflozin/Metformin Combinations in Patients with Poorly Controlled Type 2 Diabetes Mellitus: A 24-Week Multicenter Randomized Placebo-Controlled Parallel-Design Phase-3 Trial with a 28-Week Extension. Diabetes Metab J. 2023 Nov;47(6):808-817. doi: 10.4093/dmj.2022.0387. Epub 2023 Sep 26.
Other Identifiers
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DA1229_DMTD_III
Identifier Type: -
Identifier Source: org_study_id