NCT01512849

A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

An Open-Label, Randomized, 2 Way Crossover, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

Detailed description

This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	TA-7284 Low	Low
DRUG	TA-7284 High	High

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-01-19
• Last updated: 2026-01-08
• Results posted: 2014-06-11

Locations

1 site across 1 country: Japan