A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: ASP1941; Drug: Placebo

• Registration Number: NCT01023945
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-11-07
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-02
• Primary Completion: 2010-03-26
• Study Completion: 2010-03-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Type 2 diabetic patients for at least 12 weeks
• HbA1c value between 7.0 and 10.0% at screening
• Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening
• Body Mass Index (BMI) 20.0 - 45.0 kg/m2.

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Exclusion Criteria

• Type 1 diabetes mellitus patients
• Serum creatinine > upper limit of normal
• Proteinuria（albumin/creatinine ratio > 300mg/g）
• Dysuria and/or urinary tract infection
• Significant renal, hepatic or cardiovascular diseases
• Severe gastrointestinal diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP1941 high dose group	ASP1941	oral
ASP1941 low dose group	ASP1941	oral
Placebo group	Placebo	oral

Primary Outcome Measures

Name	Time	Method
Change in plasma glucose levels	On day 14

Secondary Outcome Measures

Name	Time	Method
Urinary glucose excursion	On day 14
Change in serum insulin levels	On day 14
Pharmacokinetic parameter of ASP1941	On day 14
Safety by adverse events, routine safety laboratories and vital signs.	During treatment