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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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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:

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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013