Renal Impairment Study With ASP1941

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: ASP1941


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy volunteers with normal renal function<br>Oral | Drug: ASP1941<br>* Oral<br>|
| Experimental: T2DM patient with normal renal function<br>Oral | Drug: ASP1941<br>* Oral<br>|
| Experimental: T2DM patient with mild renal impairment<br>Oral | Drug: ASP1941<br>* Oral<br>|
| Experimental: T2DM patient with moderate renal impairment<br>Oral | Drug: ASP1941<br>* Oral<br>|
| Experimental: T2DM patient with severe renal impairment<br>Oral | Drug: ASP1941<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of grade of renal impairment on the pharmacokinetics of ASP1941 |  | 5 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Impairment, ASP1941, Pharmacokinetics