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

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. Identifier: NCT01097681
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : October 12, 2018
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ASP1941 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 16, 2010
Actual Primary Completion Date : June 18, 2010
Actual Study Completion Date : June 18, 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Normal renal function group
Drug: ASP1941

Experimental: Mild renal impairment group
Drug: ASP1941

Experimental: Moderate renal impairment group
Drug: ASP1941

Primary Outcome Measures :
  1. Plasma concentration of ASP1941 [ Time Frame: For 72 hours after dosing ]

Secondary Outcome Measures :
  1. Urinary levels of ASP1941 [ Time Frame: For 72 hours after dosing ]
  2. Urinary glucose excretion [ Time Frame: For 72 hours after dosing ]
  3. Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: For 72 hours after dosing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01097681

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Kansai, Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
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Study Chair: Use Central Contact Astellas Pharma Inc
Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT01097681    
Other Study ID Numbers: 1941-CL-0073
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc:
Urinary glucose excretion
Diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs