A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01097681
First received: March 31, 2010
Last updated: January 18, 2016
Last verified: January 2016
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Purpose
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: ASP1941 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Plasma concentration of ASP1941 [ Time Frame: For 72 hours after dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Urinary levels of ASP1941 [ Time Frame: For 72 hours after dosing ] [ Designated as safety issue: No ]
- Urinary glucose excretion [ Time Frame: For 72 hours after dosing ] [ Designated as safety issue: No ]
- Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: For 72 hours after dosing ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | February 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Normal renal function group |
Drug: ASP1941
oral
|
| Experimental: Mild renal impairment group |
Drug: ASP1941
oral
|
| Experimental: Moderate renal impairment group |
Drug: ASP1941
oral
|
Eligibility| Ages Eligible for Study: | 20 Years to 79 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097681
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097681
Locations
| Japan | |
| Kansai, Japan | |
| Kantou, Japan | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Use Central Contact | Astellas Pharma Inc |
More Information
Additional Information:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01097681 History of Changes |
| Other Study ID Numbers: | 1941-CL-0073 |
| Study First Received: | March 31, 2010 |
| Last Updated: | January 18, 2016 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on September 23, 2016