A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
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ClinicalTrials.gov Identifier: NCT01097681 |
Recruitment Status
:
Completed
First Posted
: April 2, 2010
Last Update Posted
: January 20, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: ASP1941 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Normal renal function group |
Drug: ASP1941
oral
|
Experimental: Mild renal impairment group |
Drug: ASP1941
oral
|
Experimental: Moderate renal impairment group |
Drug: ASP1941
oral
|
- Plasma concentration of ASP1941 [ Time Frame: For 72 hours after dosing ]
- Urinary levels of ASP1941 [ Time Frame: For 72 hours after dosing ]
- Urinary glucose excretion [ Time Frame: For 72 hours after dosing ]
- Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: For 72 hours after dosing ]

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Ages Eligible for Study: | 20 Years to 79 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 2 diabetic patients for at least 12 weeks
- Fasting plasma glucose level of < 240 mg/dL
- Body Mass Index ( BMI )20.0 - 35.0kg/m2
- GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2
Exclusion Criteria:
- Type 1 diabetes mellitus patients
- Receiving insulin within 12 weeks before screening
- Diabetic ketoacidosis
- Dysuria and/or urinary tract infection, genital infection
- Significant renal, hepatic or cardiovascular diseases
- Severe gastrointestinal diseases

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): NCT01097681
Japan | |
Kansai, Japan | |
Kantou, Japan |
Study Chair: | Use Central Contact | Astellas Pharma Inc |
Additional Information:
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT01097681 History of Changes |
Other Study ID Numbers: |
1941-CL-0073 |
First Posted: | April 2, 2010 Key Record Dates |
Last Update Posted: | January 20, 2016 |
Last Verified: | January 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Astellas Pharma Inc:
ASP1941 Diabetes mellitus Urinary glucose excretion |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Renal Insufficiency Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Kidney Diseases Urologic Diseases |