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

A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01023945

Enrollment

Registered

2009-12-02

Start date

2009-11-07

Completion date

2010-03-26

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

ASP1941, Diabetes mellitus, Blood glucose

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.

Interventions

DRUGASP1941

oral

DRUGPlacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in plasma glucose levels	On day 14

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026