Renal Impairment Study With ASP1941

Astellas

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: ASP1941

Study type: Interventional

Funder types: Industry

Identifiers

NCT01302028

2009-011320-61 (EudraCT Number)

1941-CL-0064

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

Healthy volunteers with normal renal function

Active Comparator group

Description:

Oral

Treatment:

Drug: ASP1941

T2DM patient with normal renal function

Experimental group

Description:

Oral

Treatment:

Drug: ASP1941

T2DM patient with mild renal impairment

Experimental group

Description:

Oral

Treatment:

Drug: ASP1941

T2DM patient with moderate renal impairment

Experimental group

Description:

Oral

Treatment:

Drug: ASP1941

T2DM patient with severe renal impairment

Experimental group

Description:

Oral

Treatment:

Drug: ASP1941