A Study of ASP1941 in Participants With Type 2 Diabetes Mellitus

Astellas

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: ipragliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621868

1941-CL-0103

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP1941 in male and female patients with type 2 diabetes mellitus

Enrollment: 361 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Established diagnosis of type 2 diabetes mellitus
• Fasting serum C-peptide level > 0.6 ng/mL
• HbA1c between 7.0 and 10.0%
• Body Mass Index between 20 and 45 kg/m2

Exclusion criteria

• Serum creatinine > upper limit of normal
• Proteinuria (albumin/creatinine ratio > 300 mg/g)
• Dysuria and/or urinary tract infection
• Significant renal, hepatic or cardiovascular diseases
• Ketosis
• Hypertension
• Severe gastrointestinal diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

361 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

Lowest dose

Treatment:

Drug: ipragliflozin

2

Experimental group

Description:

Low-middle dose

Treatment:

Drug: ipragliflozin

3

Experimental group

Description:

High-middle dose

Treatment:

Drug: ipragliflozin

4

Experimental group

Description:

Highest dose

Treatment:

Drug: ipragliflozin

5

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo