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

Tanabe Pharma Corporation

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: TA-7284 Low

Drug: TA-7284 High

Study type

Interventional

Funder types

Industry

Identifiers

NCT01512849

TA-7284-07

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

40 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment
Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening
HbA1c of ≥6.5% and ≤10.5% at screening

Exclusion criteria

Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
Past or current history of severe diabetic complications
Patients requiring insulin therapy
History of hereditary glucose-galactose malabsorption or primary renal glucosuria