Renal Impairment Study With ASP1941

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: ASP1941

• Registration Number: NCT01302028
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-22
• Primary Completion: 2010-06-26
• Study Completion: 2010-06-26
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-21
• Study First Posted: 2011-02-23
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T2DM patient with mild renal impairment	ASP1941	Oral
T2DM patient with normal renal function	ASP1941	Oral
T2DM patient with moderate renal impairment	ASP1941	Oral
Healthy volunteers with normal renal function	ASP1941	Oral
T2DM patient with severe renal impairment	ASP1941	Oral

Primary Outcome Measures

Name	Time	Method
Effect of grade of renal impairment on the pharmacokinetics of ASP1941	5 days

Secondary Outcome Measures

Name	Time	Method
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