Renal Impairment Study With ASP1941

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01302028
First received: February 21, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of grade of renal impairment on the pharmacodynamics of ASP1941 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG [ Time Frame: 5 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302028

Locations
Czech Republic
Brno, Czech Republic, 62500
Prague, Czech Republic, 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 BV
  More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT01302028     History of Changes
Other Study ID Numbers: 1941-CL-0064, 2009-011320-61
Study First Received: February 21, 2011
Last Updated: February 21, 2011
Health Authority: Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

ClinicalTrials.gov processed this record on April 15, 2014