A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment

This study has been completed.

Sponsor:

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

History of Changes

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 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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Plasma concentration of ASP1941 [ Time Frame: For 72 hours after dosing ]

Secondary Outcome Measures:

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 ]


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)
Sexes Eligible for Study:	All
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

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:

Link to Results on JAPIC - enter 150715 in the JapicCTI-RNo. field This link exits the ClinicalTrials.gov site

Link to results on Astellas Clinical Study Results Web site This link exits the ClinicalTrials.gov site


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
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

ClinicalTrials.gov processed this record on August 18, 2017

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