Renal Impairment Study With ASP1941

August 21, 2017 updated by: Astellas Pharma Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 62500
      • Prague, Czechia, 16900
  • Hungary
      • Balatonfured, Hungary, 8230
  • Poland
      • Warsaw, Poland, 02-097
  • Slovakia
      • Bratislava, Slovakia, 83305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of grade of renal impairment on the pharmacokinetics of ASP1941
Time Frame: 5 days
5 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2010

Primary Completion (Actual)

June 26, 2010

Study Completion (Actual)

June 26, 2010

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

February 21, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1941-CL-0064
  • 2009-011320-61 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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