A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: ipragliflozin; Drug: Placebo

• Registration Number: NCT00621868
• Lead Sponsor: Astellas Pharma Inc

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-22
• Study Start: 2008-03-26
• Primary Completion: 2009-03-14
• Study Completion: 2009-03-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ipragliflozin	Low-middle dose
4	ipragliflozin	Highest dose
5	Placebo	placebo
1	ipragliflozin	Lowest dose
3	ipragliflozin	High-middle dose

Primary Outcome Measures

Name	Time	Method
HbA1c level	12 weeks

Secondary Outcome Measures

Name	Time	Method
Blood glucose level	12 Weeks
Safety	12 Weeks