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NCT00621868 Clinical Trial

A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00621868
Other study ID # 1941-CL-0103
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 26, 2008
Est. completion date March 14, 2009

Study information
Verified date May 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 361
Est. completion date March 14, 2009
Est. primary completion date March 14, 2009
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

- Ketosis

- Hypertension

- Severe gastrointestinal diseases

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ipragliflozin
Oral
• Placebo
Oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c level 12 weeks
Secondary Blood glucose level 12 Weeks
Secondary Safety 12 Weeks
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