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
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: 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 B.V.
  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 July 23, 2014