We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Renal Impairment Study With ASP1941

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302028
First Posted: February 23, 2011
Last Update Posted: August 22, 2017
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients with normal renal function and healthy volunteers.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: ASP1941 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Parallel Group Study to Assess the Effect of Different Grades of Renal Impairment in Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics and Safety & Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus With Normal Renal Function and Healthy Volunteers

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Effect of grade of renal impairment on the pharmacokinetics of ASP1941 [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • Effect of grade of renal impairment on the pharmacodynamics of ASP1941 [ Time Frame: 5 days ]
  • Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG [ Time Frame: 5 days ]

Enrollment: 40
Actual Study Start Date: January 22, 2010
Study Completion Date: June 26, 2010
Primary Completion Date: June 26, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy volunteers with normal renal function
Oral
Drug: ASP1941
Oral
Experimental: T2DM patient with normal renal function
Oral
Drug: ASP1941
Oral
Experimental: T2DM patient with mild renal impairment
Oral
Drug: ASP1941
Oral
Experimental: T2DM patient with moderate renal impairment
Oral
Drug: ASP1941
Oral
Experimental: T2DM patient with severe renal impairment
Oral
Drug: ASP1941
Oral

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient with stable type 2 diabetes mellitus or healthy subject
  • Subject must have pre-dose estimated Glomerular filtration rate (GFR) values (Modification of diet in renal disease (MDRD) method) at screening of:

    • >90 (normal renal function)
    • 60-90 (mild renal impairment)
    • 30-60 (moderate renal impairment)
    • 15-30 (severe renal impairment)
  • BMI between 25.0-40.0 kg/m2, inclusive
  • Fasted plasma glucose (FPG) <11.5 mmol/l (type 2 DM patients) or >5.6 mmol/l (Healthy volunteers)

Exclusion Criteria:

  • Patients with Type 1 diabetes
  • Pulse <40 or >90; SBP >160 mmHg; DBP > 100 mmHg
  • T2DM patients who are not on a stable regimen for their current medication (1 month or 5 half lives, whichever is longer) to control their disease
  • Healthy Volunteers: Any of the liver function tests above the upper limit of normal
  • T2DM: The liver function tests should be within the following ranges:

    • AST/ALT: <2 x ULN
    • Bilirubin: <1.5 x ULN
    • Alk Phos: < 1.5 x ULN
  • Patients with renal impairment who have a history of a clinically significant illness (other than renal diseases and T2DM and associated clinical symptoms), medical condition, or laboratory abnormality within 3 months prior to screening
  • Patients with renal impairment who have not been on a stable dose of concomitant medications for at least 2 weeks for at least 2 weeks (or 5 halflives, whichever is longer) and/or for whom dose changes are likely to occur during the study
  • Patients with T2DM treated with a diet only
  • T2DM patients with recent evidence (e.g within the last 6 months) of severe hypoglycemia, for example plasma glucose < 3mmol/l (<55 mg/dl), help from others to resolve the hypo or requiring hospitalization
  • T2DM patients with a Hemoglobin value < 9 g/dl (5.6 mmol/l)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01302028


Locations
Czechia
Brno, Czechia, 62500
Prague, Czechia, 16900
Hungary
Balatonfured, Hungary, 8230
Poland
Warsaw, Poland, 02-097
Slovakia
Bratislava, Slovakia, 83305
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01302028     History of Changes
Other Study ID Numbers: 1941-CL-0064
2009-011320-61 ( EudraCT Number )
First Submitted: February 21, 2011
First Posted: February 23, 2011
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Astellas Pharma Inc:
Renal Impairment
ASP1941
Pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases