A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus

Astellas

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin; Drug: ipragliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01071850

1941-CL-0004

Details and patient eligibility

About

Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.

Enrollment: 412 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has been diagnosed with type 2 diabetes
• Subject has a HbA1c value between 6.8 and 9.5%
• Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
• Subject is on a stable diet and exercise program
• Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study

Exclusion criteria

• Subject has type 1 diabetes mellitus
• Subject is using insulin therapy
• Subject has a serum creatinine higher than upper limit of normal
• Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
• Subject has persistent, uncontrolled severe hypertension as indicated by a

systolic blood pressure >180 mmHg or a diastolic blood pressure of

>110mmHg

• Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
• Subject is known to have hepatitis or be a carrier of hepatitis B surface

antigen, hepatitis C virus antibody or is known positive for HIV1 and/or

HIV2

• Subject has a history of lactic acidosis
• Subject has a history of drug and alcohol abuse/dependency within last 12

months

• Subject has had a malignancy in the last 5 years, except for successfully

treated basal or squamous cell carcinoma of the skin or of the cervix

• Subject has a symptomatic urinary tract infection or genital infection
• Female subject is lactating
• Subject has an unstable medical or psychiatric illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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412 participants in 6 patient groups, including a placebo group

ASP1941 lowest dose

Experimental group

Description:

oral tablet

Treatment:

Drug: ipragliflozin

ASP1941 low dose

Experimental group

Description:

oral tablet

Treatment:

Drug: ipragliflozin

ASP1941 high dose

Experimental group

Description:

oral tablet

Treatment:

Drug: ipragliflozin

ASP1941 highest dose

Experimental group

Description:

oral tablet

Treatment:

Drug: ipragliflozin

Metformin

Active Comparator group

Description:

oral tablet

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

oral tablet

Treatment:

Drug: Placebo