Efficacy and safety of Gemigliptin as add-on therapy to insulin with or without metformin, in patients with type 2 diabetes mellitus

Efficacy and safety of gemigliptin as add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210225005

Enrollment

285

Registered

2021-02-25

Start date

2016-10-17

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus Patients T2DM

Interventions

the subjects should visit a study site at an interval of 6 weeks during the treatment period for 24 weeks in total, For patients who have been taking metformin, the patients who had taken at least 10

Active Comparator Drug,Placebo Comparator Drug

Gemigliptin 50mg,Gemigliptin 50mg placebo

Eligibility

Sex/Gender

All

Age

19 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus of 19 years and above of age at the time of Visit 1 (Screening) and other details in https://clinicaltrials.gov/ct2/show/NCT02831361

Exclusion criteria

Exclusion criteria: Patients with type 1 diabetes mellitus, gestational diabetes, or secondary diabetes and other details as in https://clinicaltrials.gov/ct2/show/NCT02831361

Design outcomes

Primary

Measure	Time frame
changes from baseline HbA1c at week 25 baseline (Visit 2) and week 25 (visit 6) HbA1c	—

Secondary

Measure	Time frame
Responder Rate at week 25 week 25 (visit 6) HbA1c 7% , HbA1c 6.5%,Changes of HbA1c at each visit baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6) values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of FPG at each visit baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6) values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of Fasting serum C-peptide at week 25 baseline (Visit 2) and week 25 (visit 6) Fasting serum C-peptide,Changes of HOMA-IR at week 25 baseline (Visit 2) and week 25 (visit 6) HOMA-IR,Changes of HOMA-B at week 25 baseline (Visit 2) and week 25 (visit 6) HOMA-B ,Changes of Total Cholesterol at week 25 baseline (Visit 2) and week 25 (visit 6) Total Cholesterol,Changes of cardiovascular disease parameter at week 25 baseline (Visit 2) and week 25 (visit 6) hsCRP,Changes of body weight at each visit baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6) values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of waist circumference at each visit baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6) values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of total daily dose at each visit Time Frame: visit 2, visit 3, visit 4, visit 5, visit 6 values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of LDL-C at week 25 baseline (Visit 2) and week 25 (visit 6) LDL-C,Changes of HDL-C at week 25 baseline (Visit 2) and week 25 (visit 6) HDL-C ,Changes of Triglyceride at week 25 baseline (Visit 2) and week 25 (visit 6) Triglyceride	—

Measure

Time frame

Responder Rate at week 25 week 25 (visit 6) HbA1c 7% , HbA1c 6.5%,Changes of HbA1c at each visit baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6) values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of FPG at each visit baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6) values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of Fasting serum C-peptide at week 25 baseline (Visit 2) and week 25 (visit 6) Fasting serum C-peptide,Changes of HOMA-IR at week 25 baseline (Visit 2) and week 25 (visit 6) HOMA-IR,Changes of HOMA-B at week 25 baseline (Visit 2) and week 25 (visit 6) HOMA-B ,Changes of Total Cholesterol at week 25 baseline (Visit 2) and week 25 (visit 6) Total Cholesterol,Changes of cardiovascular disease parameter at week 25 baseline (Visit 2) and week 25 (visit 6) hsCRP,Changes of body weight at each visit baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6) values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of waist circumference at each visit baseline(visit 2), week 7(visit 3), week 13(visit 4), week 19(visit 5), week 25(visit 6) values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of total daily dose at each visit Time Frame: visit 2, visit 3, visit 4, visit 5, visit 6 values of parameters at the corresponding visit - values of parameters at visit 2(baseline),Changes of LDL-C at week 25 baseline (Visit 2) and week 25 (visit 6) LDL-C,Changes of HDL-C at week 25 baseline (Visit 2) and week 25 (visit 6) HDL-C ,Changes of Triglyceride at week 25 baseline (Visit 2) and week 25 (visit 6) Triglyceride

—

Countries

Korea, Democratic People's Republic of

Contacts

Public ContactMoon Kyu Lee

leemk@skku.edu82234100200

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026