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

This study has been completed.

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01055652

First received: January 22, 2010

Last updated: October 14, 2011

Last verified: October 2010

History of Changes

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Dapagliflozin	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label)
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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Dapagliflozin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 [ Time Frame: 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:

To evaluate the safety and tolerability of dapagliflozin when administered alone or in combi-nation with voglibose in Japanese patients with type 2 diabetes. [ Time Frame: 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. [ Time Frame: 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. ]


Enrollment:	28
Study Start Date:	January 2010
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Dapagliflozin 10mg, oral, once daily

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055652

Locations


Japan
Research Site
Moriya, Japan
Research Site
Osaka, Japan

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators


Study Director:	Nobuyuki Shiga	AstraZeneca

More Information


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01055652 History of Changes
Other Study ID Numbers:	D1692C00002
Study First Received:	January 22, 2010
Last Updated:	October 14, 2011

Keywords provided by AstraZeneca:


Type 2 diabetes mellitus Japanese phase 1 safety	dapagliflozin Pharmacokinetics Drug-drug Interaction voglibose

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Voglibose	Hypoglycemic Agents Physiological Effects of Drugs Glycoside Hydrolase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 19, 2017

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