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)

LG Life Sciences

Status and phase: Completed; Phase 3

Conditions: Type 2 DM Patients With Moderate or Severe Renal Impairment

Treatments: Drug: Placebo to Linagliptin; Drug: Gemigliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968044

LG-DPCL015

Details and patient eligibility

About

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).

Enrollment: 132 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Gemigliptin

Experimental group

Description:

Participant will remain gemigliptin 50mg throughout entire study (52 weeks).

Treatment:

Drug: Gemigliptin

Placebo to linagliptin

Other group

Description:

Participant who is randomized to placebo will be switched to linagliptin after 12 week and administered linagliptin by week 52.

Treatment:

Drug: Placebo to Linagliptin