Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00621868
NCT00621868
Completed
Phase 2

ASP1941 Phase II Clinical Study - A Double-blind, Placebo-controlled, Parallel-group, Dose-response Study in Patients With Type 2 Diabetes Mellitus

Astellas Pharma Inc0 sites361 target enrollmentMarch 26, 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsDiabetes Mellitus
InterventionsipragliflozinPlacebo
DrugsipragliflozinPlacebo

Overview

Phase
Phase 2
Intervention
ipragliflozin
Conditions
Diabetes Mellitus
Sponsor
Astellas Pharma Inc
Enrollment
361
Primary Endpoint
HbA1c level
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus

Registry
clinicaltrials.gov
Start Date
March 26, 2008
End Date
March 14, 2009
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Established diagnosis of type 2 diabetes mellitus
  • •Fasting serum C-peptide level \> 0.6 ng/mL
  • •HbA1c between 7.0 and 10.0%
  • •Body Mass Index between 20 and 45 kg/m2

Exclusion Criteria

  • •Serum creatinine \> upper limit of normal
  • •Proteinuria (albumin/creatinine ratio \> 300 mg/g)
  • •Dysuria and/or urinary tract infection
  • •Significant renal, hepatic or cardiovascular diseases
  • •Hypertension
  • •Severe gastrointestinal diseases

Arms & Interventions

1

Lowest dose

Intervention: ipragliflozin

2

Low-middle dose

Intervention: ipragliflozin

3

High-middle dose

Intervention: ipragliflozin

4

Highest dose

Intervention: ipragliflozin

5

placebo

Intervention: Placebo

Outcomes

Primary Outcomes

HbA1c level

Time Frame: 12 weeks

Secondary Outcomes

  • Blood glucose level(12 Weeks)
  • Safety(12 Weeks)

Similar Trials

Completed
Phase 1
A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy SubjectsHealthy VolunteerPharmacokinetics of ASP1941
NCT01121198Astellas Pharma Inc84
Completed
Phase 2
Pharmacodynamics, Pharmacokinetics, and Safety of ASP1941 in Patients With Type 1 Diabetes MellitusType 1 Diabetes Mellitus
NCT02529449Astellas Pharma Inc43
Completed
Phase 1
Drug to Drug Interaction Study With ASP1941 and MetforminType 2 Diabetes Mellitus
NCT01302145Astellas Pharma Inc36
Completed
Phase 1
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese SubjectsHealthyPharmacokinetics of ASP1941
NCT01373060Astellas Pharma Inc56
Completed
Phase 1
Study of the Pharmacokinetics of ASP1941 and the Effect on Glucose Concentrations in Male and Female Young and Elderly Healthy AdultsHealthy VolunteersPharmacokinetics of ASP1941
NCT01678287Astellas Pharma Global Development, Inc.65