Renal Impairment Study With ASP1941

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01302028
• Date of registration: 21/02/2011
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Inc
• Public title: Renal Impairment Study With ASP1941
• Scientific 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
• Date of first enrolment: January 22, 2010
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01302028
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Czech Republic, Czechia, Hungary, Poland, Slovakia

Contacts

• Name: Use Central Contact
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

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)



Age minimum: 45 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: ASP1941

Primary Outcome(s)

Effect of grade of renal impairment on the pharmacokinetics of ASP1941 [Time Frame: 5 days]

Secondary Outcome(s)

Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG [Time Frame: 5 days]

Effect of grade of renal impairment on the pharmacodynamics of ASP1941 [Time Frame: 5 days]

Secondary ID(s)

2009-011320-61

1941-CL-0064

Source(s) of Monetary Support

Please refer to primary and secondary sponsors