A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study)
NCT ID: NCT01968044
Last Updated: 2016-03-23
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
132 participants
INTERVENTIONAL
2013-10-31
2015-10-31
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
DOUBLE
Study Groups
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Gemigliptin
Participant will remain gemigliptin 50mg throughout entire study (52 weeks).
Gemigliptin
Placebo to linagliptin
Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52.
Placebo to Linagliptin
Interventions
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Gemigliptin
Placebo to Linagliptin
Eligibility Criteria
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Inclusion Criteria
* Patients with moderate or severe renal insufficiency
* All patients give written informed consent
Exclusion Criteria
* Is on dialysis or is likely to need dialysis during the study
* Has active liver disease
19 Years
75 Years
ALL
No
Sponsors
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LG Life Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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DR Cha, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Korea University Ansan Hospital
Locations
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Seoul, , South Korea
Countries
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Other Identifiers
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LG-DPCL015
Identifier Type: -
Identifier Source: org_study_id
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