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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Dapagliflozin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Dapagliflozin<br>* 10mg, oral, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of dapagliflozin when administered alone or in combi-nation with voglibose in Japanese patients with type 2 diabetes. |  | 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. | 
| 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. |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Japanese, phase 1, safety, dapagliflozin, Pharmacokinetics, Drug-drug Interaction, voglibose