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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01302028
Date of registration: 21/02/2011
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 2010
Target sample size: 40
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01302028
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science  
Countries of recruitment
Czech Republic Hungary Poland Slovakia
Contacts
Name:   Use Central Contact
Address: 
Telephone:
Email:
Affiliation:  Astellas Pharma Europe BV
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: Both
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)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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