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Clinical Trial Details

Trial ID: L6477
Source ID: NCT02831361
Associated Drug: Gemigliptin
Title: Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in Combination With Metformin in Type 2 DM (ZEUS II Study)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Gemigliptin|DRUG: Gemigliptin placebo|DRUG: Metformin|PROCEDURE: Diet/exercise questionnaire
Outcome Measures: Primary: changes from baseline HbA1c at week 25, baseline (Visit 2) and week 25 (visit 6) | Secondary: Responder Rate at week 25, HbA1c \<7% , HbA1c \<6.5%, week 25 (visit 6)|Changes of HbA1c at each visit, values of parameters at the corresponding visit - values of parameters at visit 2(baseline), baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6)|Changes of FPG at each visit, values of parameters at the corresponding visit - values of parameters at visit 2(baseline), baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6)|Changes of Fasting serum C-peptide at week 25, baseline (Visit 2) and week 25 (visit 6)|Changes of HOMA-IR at week 25, baseline (Visit 2) and week 25 (visit 6)|Changes of HOMA-β at week 25, baseline (Visit 2) and week 25 (visit 6) | Other: Changes of Total Cholesterol at week 25, baseline (Visit 2) and week 25 (visit 6)|Changes of cardiovascular disease parameter at week 25, hsCRP, baseline (Visit 2) and week 25 (visit 6)|Changes of body weight at each visit, values of parameters at the corresponding visit - values of parameters at visit 2(baseline), baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6)|Changes of waist circumference at each visit, values of parameters at the corresponding visit - values of parameters at visit 2(baseline), baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6)|Changes of total daily dose at each visit, values of parameters at the corresponding visit - values of parameters at visit 2(baseline), visit 2, visit 3, visit 4, visit 5, visit 6|Changes of LDL-C at week 25, baseline (Visit 2) and week 25 (visit 6)|Changes of HDL-C at week 25, baseline (Visit 2) and week 25 (visit 6)|Changes of Triglyceride at week 25, baseline (Visit 2) and week 25 (visit 6)
Sponsor/Collaborators: Sponsor: LG Life Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 290
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-10-17
Completion Date: 2018-02-08
Results First Posted:
Last Update Posted: 2018-02-22
Locations:
URL: https://clinicaltrials.gov/show/NCT02831361