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

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Dapagliflozin
10mg, oral, once daily
|
- 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. ]
- 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. ]

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

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
Japan | |
Research Site | |
Moriya, Japan | |
Research Site | |
Osaka, Japan |
Study Director: | Nobuyuki Shiga | AstraZeneca |
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 |