Who is sponsoring NCT01968044?

NCT01968044 is sponsored by LG Life Sciences.

What drugs are being tested in NCT01968044?

Interventions in NCT01968044: Gemigliptin, Placebo to Linagliptin.

What condition does NCT01968044 study?

NCT01968044 studies Type 2 DM Patients With Moderate or Severe Renal Impairment.

Is NCT01968044 still recruiting?

NCT01968044 is currently completed. Last updated 21 March 2016.

Last reviewed 2016-03-21 · How we verify

NCT01968044: GUARD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter,Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase IIIb Study to Evaluate the Safety and Efficacy After 12 Weeks Administration of Gemigliptin and Placebo in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment With an Additional 40 Weeks, Double-blind,Active-controlled, Double-dummy,Long-term Extension Study

Completed Phase 3 Last updated 21 March 2016

What this trial tests

Phase 3 trial testing Gemigliptin in Type 2 DM Patients With Moderate or Severe Renal Impairment in 132 participants. Completed in 1 October 2015.

Timeline

1 October 2013

Primary endpoint
1 October 2015

1 October 2015

Quick facts

Lead sponsor	LG Life Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	132
Start date	1 October 2013
Primary completion	1 October 2015
Estimated completion	1 October 2015
Sites	1 location across South Korea

Drugs / interventions tested

Gemigliptin (GEMIGLIPTIN) — full drug profile →
Placebo to Linagliptin — full drug profile →

Conditions studied

Type 2 DM Patients With Moderate or Severe Renal Impairment — all drugs for Type 2 DM Patients With Moderate or Severe Renal Impairment →

Sponsor

LG Life Sciences — full company profile →

Who can join

Adults 19 to 75, any sex, with Type 2 DM Patients With Moderate or Severe Renal Impairment. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

HbA1c change
Time frame: HbA1c change from baseline to week 12

Sponsor's own description

Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or severe renal impairment for long-term peirod (52 weeks).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Gemigliptin: An Update of Its Clinical Use in the Management of Type 2 Diabetes Mellitus.
Kim SH, Yoo JH, Lee WJ, Park CY. · · 2016 · cited 41× · PMID 27766241 · DOI 10.4093/dmj.2016.40.5.339
Treatments for Chronic Kidney Disease: A Systematic Literature Review of Randomized Controlled Trials.
Garcia Sanchez JJ, Thompson J, Scott DA, Evans R, et al · · 2022 · cited 26× · PMID 34881414 · DOI 10.1007/s12325-021-02006-z
Abstracts of 52nd EASD Annual Meeting.
· 2016 · cited 6× · PMID 27539147 · DOI 10.1007/s00125-016-4046-9

Verify or expand the search:

Other trials of Gemigliptin

Trials testing the same drug.

NCT05194592 — Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabete · Phase 4 · unknown
NCT05663736 — Effect of Gemigliptin Versus Glimepiride on Cardiac Diastolic Function in Patients With Type 2 Diabetes · Phase 4 · unknown
NCT03565458 — Gemigliptin, Dapagliflozin, Empagliflozin DDI Study · Phase 1 · unknown
NCT04705506 — Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification · NA · completed
NCT02831361 — Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in C · Phase 3 · completed

Other LG Life Sciences trials

Trials by the same sponsor.

NCT02831361 — Trial to Evaluate the Efficacy and Safety of Gemigliptin Compared With Placebo Added on Insulin Alone or on Insulin in C · Phase 3 · completed
NCT03015909 — Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. · Phase 4 · completed
NCT02746380 — A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy · Phase 3 · completed
NCT02290301 — An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01968044 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LG Life Sciences
Last refreshed: 21 March 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01968044.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing