A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.

A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00790660

Enrollment

Registered

2008-11-13

Start date

2008-10-23

Completion date

2009-03-06

Last updated

2024-11-14

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

Conditions

Diabetes Mellitus, Type 2

Keywords

ASP1941, Type 2 Diabetes Mellitus

Brief summary

This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus

Detailed description

Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.

Interventions

DRUGASP1941

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Established diagnosis of type 2 diabetes mellitus * HbA1c value between 7.0 and 10.0% * Body mass index between 20 and 45 kg/m2

Exclusion criteria

* Established diagnosis of type 1 diabetes mellitus * Serum creatinine \> upper limit of normal range * Proteinuria (microalbumin/creatinine ratio \> 300 mg/g) * Urinary tract infection * Severe uncontrolled Hypertension * Significant renal, hepatic or cardiovascular disease * HIV Positive * History of drug or alcohol abuse/dependency

Design outcomes

Primary

Measure	Time frame
Evaluation of safety through clinical safety labs and adverse events	6 Weeks

Secondary

Measure	Time frame
Evaluation of routine PK and PD parameters	6 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026