Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01055652

D1692C00002

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in Japanese patients with type 2 diabetes by assessment of AUC and Cmax of dapagliflozin

Enrollment: 28 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Already on voglibose treatment with a steady dosage for at least 8 weeks
• Provision of informed consent prior to any study specific procedures
• Diagnosed with type 2 diabetes

Exclusion criteria

• Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
• The investigator(s)judged that the Subject should not participate in the study according to screening test or medical history.

Trial design

28 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Dapagliflozin