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

February 21, 2011
February 21, 2011
January 2010
June 2010   (final data collection date for primary outcome measure)
Effect of grade of renal impairment on the pharmacokinetics of ASP1941 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Renal Impairment Study With ASP1941
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
Drug: ASP1941
oral
  • Active Comparator: Healthy volunteers with normal renal function
    Intervention: Drug: ASP1941
  • Experimental: T2DM patient with normal renal function
    Intervention: Drug: ASP1941
  • Experimental: T2DM patient with mild renal impairment
    Intervention: Drug: ASP1941
  • Experimental: T2DM patient with moderate renal impairment
    Intervention: Drug: ASP1941
  • Experimental: T2DM patient with severe renal impairment
    Intervention: Drug: ASP1941
Ferrannini E, Veltkamp SA, Smulders RA, Kadokura T. Renal glucose handling: impact of chronic kidney disease and sodium-glucose cotransporter 2 inhibition in patients with type 2 diabetes. Diabetes Care. 2013 May;36(5):1260-5. doi: 10.2337/dc12-1503. Epub 2013 Jan 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2010
June 2010   (final data collection date for primary outcome measure)

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)
Both
45 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Hungary,   Poland,   Slovakia
 
NCT01302028
1941-CL-0064, 2009-011320-61
No
Disclosure Office Europe, Astellas Pharma Europe BV
Astellas Pharma Inc
Not Provided
Study Director: Use Central Contact Astellas Pharma Europe BV
Astellas Pharma Inc
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP