NCT01302028

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2010

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

5 months

First QC Date

February 21, 2011

Last Update Submit

August 21, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

Renal ImpairmentASP1941Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Effect of grade of renal impairment on the pharmacokinetics of ASP1941

    5 days

Secondary Outcomes (2)

  • Effect of grade of renal impairment on the pharmacodynamics of ASP1941

    5 days

  • Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG

    5 days

Study Arms (5)

Healthy volunteers with normal renal function

ACTIVE COMPARATOR

Oral

Drug: ASP1941

T2DM patient with normal renal function

EXPERIMENTAL

Oral

Drug: ASP1941

T2DM patient with mild renal impairment

EXPERIMENTAL

Oral

Drug: ASP1941

T2DM patient with moderate renal impairment

EXPERIMENTAL

Oral

Drug: ASP1941

T2DM patient with severe renal impairment

EXPERIMENTAL

Oral

Drug: ASP1941

Interventions

ASP1941DRUG

Oral

Healthy volunteers with normal renal functionT2DM patient with mild renal impairmentT2DM patient with moderate renal impairmentT2DM patient with normal renal functionT2DM patient with severe renal impairment

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • (mild renal impairment)
  • (moderate renal impairment)
  • (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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Brno, 62500, Czechia

Location

Unknown Facility

Prague, 16900, Czechia

Location

Unknown Facility

Balatonfüred, 8230, Hungary

Location

Unknown Facility

Warsaw, 02-097, Poland

Location

Unknown Facility

Bratislava, 83305, Slovakia

Location

Related Publications (1)

  • 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.

    PMID: 23359360DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Renal Insufficiency

Interventions

ipragliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Use Central Contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2011

First Posted

February 23, 2011

Study Start

January 22, 2010

Primary Completion

June 26, 2010

Study Completion

June 26, 2010

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

PL(1)CZ(2)SL(1)HU(1)