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

Astellas

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: ASP1941; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00790660

1941-CL-0016

Details and patient eligibility

About

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

Full description

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

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 5 patient groups, including a placebo group

ASP1941 Lowest Dose

Experimental group

Description:

Oral

Treatment:

Drug: ASP1941

ASP1941 Low Dose

Experimental group

Description:

Oral

Treatment:

Drug: ASP1941

ASP1941 Medium Dose

Experimental group

Description:

Oral

Treatment:

Drug: ASP1941

ASP1941 High Dose

Experimental group

Description:

Oral

Treatment:

Drug: ASP1941

Placebo

Placebo Comparator group

Description:

Oral

Treatment:

Drug: Placebo