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

Astellas

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: ASP1941; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01023945

1941-CL-0070

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 3 patient groups, including a placebo group

ASP1941 high dose group

Experimental group

Description:

oral

Treatment:

Drug: ASP1941

ASP1941 low dose group

Experimental group

Description:

oral

Treatment:

Drug: ASP1941

Placebo group

Placebo Comparator group

Description:

oral

Treatment:

Drug: Placebo