Renal Impairment Study With ASP1941

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302028
• Other study ID #: 1941-CL-0064
• Secondary ID: 2009-011320-61
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2011
• Last updated: August 21, 2017
• Start date: January 22, 2010
• Est. completion date: June 26, 2010

Study information

• Verified date: August 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 26, 2010
• Est. primary completion date: June 26, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ASP1941
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Czechia,  Hungary,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of grade of renal impairment on the pharmacokinetics of ASP1941		5 days
Secondary	Effect of grade of renal impairment on the pharmacodynamics of ASP1941		5 days
Secondary	Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG		5 days

External Links

•   Link to results on Astellas Clinical Study Results website