Clinical trial NCT01302028: Renal Impairment Study With ASP1941
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Renal Impairment
ASP1941
Pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: Effect of grade of renal impairment on the pharmacokinetics of ASP1941
timeFrame: 5 days
Secondary outcomes:
measure: Effect of grade of renal impairment on the pharmacodynamics of ASP1941
timeFrame: 5 days
measure: Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG
timeFrame: 5 days
Other outcomes:
Locations:
city: Brno
country: Czechia
city: Prague
country: Czechia
city: Balatonfured
country: Hungary
city: Warsaw
country: Poland
city: Bratislava
country: Slovakia
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Ferrannini E, Veltkamp SA, Smulders RA, Kadokura T. Renal glucose handling: impact of chronic kidney disease and sodium-glucose cotransporter 2 inhibition in patients with type 2 diabetes. Diabetes Care. 2013 May;36(5):1260-5. doi: 10.2337/dc12-1503. Epub 2013 Jan 28.