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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:
ClinicalTrials.gov Identifier:
NCT01055652
First Posted: January 25, 2010
Last Update Posted: October 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
January 22, 2010
January 25, 2010
October 17, 2011
January 2010
April 2010   (Final data collection date for primary outcome 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 [ 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. ]
Same as current
Complete list of historical versions of study NCT01055652 on ClinicalTrials.gov Archive Site
  • 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. ]
Same as current
Not Provided
Not Provided
 
Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients
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
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
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Type 2 Diabetes Mellitus
Drug: Dapagliflozin
10mg, oral, once daily
Experimental: 1
Intervention: Drug: Dapagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2010
April 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01055652
D1692C00002
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Director: Nobuyuki Shiga AstraZeneca
AstraZeneca
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP