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NCT01990469 Clinical Trial

Efficacy and Safety of Gemigliptin 50mg qd Added in Patients With Type 2 Diabetes Inadequately Controlled on Glimepiride and Metformin

T2DM Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01990469
Other study ID # LG-DPCL010
Secondary ID
Status Completed
Phase Phase 3
First received November 15, 2013
Last updated April 18, 2016
Start date January 2014
Est. completion date April 2015

Study information
Verified date April 2016
Source LG Life Sciences
Contact n/a
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

After a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

Description:

Subjects will visit the center on Week 6, 12, 18 and 24 during the entire 24-week treatment period. Total study duration will be approximately 26weeks and the subjects will be to practice exercise/diet control together.

Recruitment information / eligibility
Status Completed
Enrollment 219
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. Patients with Type 2 Diabetes Mellitus

2. Adults aged = 19 years old

3. Patients with HbA1c 7%~11% at Visit 1

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gemigliptin
DPP-4 inhibitor
• Gemigliptin placebo
Placebo of Gemigliptin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
LG Life Sciences

Outcome
Type Measure Description Time frame Safety issue
Primary Change of HbAlc from baseline at Week 24 24 weeks No
See also
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Recruiting NCT03564431 - The Imaging Genetic Study of Type 2 Diabetes and Depression
Recruiting NCT05159882 - Safety and Efficacy of THR-1442 Compared to Dapagliflozin as Add-on Therapy to Metformin in T2DM Phase 3