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

Astellas Pharma Inc30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

ASP1941DRUG

oral

PlaceboDRUG

oral

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. 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

Locations (1)

Unnamed facility

Kantou, Japan

Outcomes

Primary Outcomes

Change in plasma glucose levels

Time frame: On day 14

Secondary Outcomes

Urinary glucose excursion

Time frame: On day 14

Pharmacokinetic parameter of ASP1941

Time frame: On day 14

Safety by adverse events, routine safety laboratories and vital signs.

Time frame: During treatment

Change in serum insulin levels

Time frame: On day 14

Data from ClinicalTrials.gov

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