Clinical trial NCT01055652: Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients
Official title: An Open-label, Multi-centre, Drug-drug Interaction Study to Assess the Effect of Voglibose (0.2 mg Tid) on the Pharmacokinetics, Safety and Tolerability of Single Oral Administration of Dapagliflozin (10 mg) in Japanese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Japanese
phase 1
safety
dapagliflozin
Pharmacokinetics
Drug-drug Interaction
voglibose
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-01-25
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Plasma samples will be collected through Visit 4 (up to 72 hours = 3 days after dose) for PK assessment for period 1. Plasma samples will be collected through Visit 7 (up to 72 hours = 3 days after dose) for PK assessment for period 2.
Secondary outcomes:
measure: To evaluate the safety and tolerability of dapagliflozin when administered alone or in combi-nation with voglibose in Japanese patients with type 2 diabetes.
timeFrame: Plasma samples will be collected through Visit 4 (up to 72 hours = 3 days after dose) for PK assessment for period 1. Plasma samples will be collected through Visit 7 (up to 72 hours = 3 days after dose) for PK assessment for period 2.
measure: To evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in Japanese patients with type 2 diabetes by assessmentof AUC0-t, tmax, t1/2, CL/F.
timeFrame: Plasma samples will be collected through Visit 4 (up to 72 hours = 3 days after dose) for PK assessment for period 1. Plasma samples will be collected through Visit 7 (up to 72 hours = 3 days after dose) for PK assessment for period 2.
Other outcomes:
Locations:
city: Moriya
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Nobuyuki Shiga
role: STUDY_DIRECTOR
References: