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)

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LG Life Sciences
• Treatments: Linagliptin

Criteria

Inclusion Criteria:

• Patients with Type 2 Diabetes Mellitus

• Patients with moderate or severe renal insufficiency

• All patients give written informed consent

Exclusion Criteria:

• Has type 1 diabetes mellitus or a history of ketoacidosis

• Is on dialysis or is likely to need dialysis during the study

• Has active liver disease