MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus
NCT ID: NCT04810507
Last Updated: 2021-03-24
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
PHASE4
89 participants
INTERVENTIONAL
2018-11-09
2021-01-05
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
NONE
Study Groups
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Anagliptin arm
Anagliptin 100 mg twice a day
Anagliptin BID Treatment
Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks
Sitagliptin 100mg
Sitagliptin 100mg once a day
Anagliptin BID Treatment
Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks
Interventions
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Anagliptin BID Treatment
Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks.
* 6.5% ≤HbA1c\< 8.5%
* Agreed Therapeutic Lifestyle change during the study period
* Obtained Informed Consent Form
Exclusion Criteria
* History of intestinal obstruction
* NYHA class III to IV congestive heart failure,
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 X upper limit of normal (ULN) or Total bilirubin \> 3 X ULN
* Creatinine clearance (CrCl)\* \< 50 mL/min
* Thyroid-stimulating hormone (TSH) ≥ 1.5 X ULN
* Allergic history for Anagliptin 또는 sitagliptin
* Being pregnant or nursing or suspected of being pregnant, or
* History of participation in other clinical studies in the preceding 3 months.
19 Years
75 Years
ALL
No
Sponsors
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JW Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Jaewan Park
Role: STUDY_DIRECTOR
JWPharmaceuticals
Locations
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Kangdong Sacred Heart Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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JWP-GDL-404
Identifier Type: -
Identifier Source: org_study_id
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