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

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ClinicalTrials.gov Identifier: NCT01055652
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : October 17, 2011
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Dapagliflozin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Dapagliflozin
10mg, oral, once daily


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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. ]
  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. ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01055652     History of Changes
Other Study ID Numbers: D1692C00002
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2010

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