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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: ipragliflozin
* Drug: Metformin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP1941 lowest dose<br>oral tablet | Drug: ipragliflozin<br>* oral tablet<br>* Other names: ASP1941;|
| Experimental: ASP1941 low dose<br>oral tablet | Drug: ipragliflozin<br>* oral tablet<br>* Other names: ASP1941;|
| Experimental: ASP1941 high dose<br>oral tablet | Drug: ipragliflozin<br>* oral tablet<br>* Other names: ASP1941;|
| Experimental: ASP1941 highest dose<br>oral tablet | Drug: ipragliflozin<br>* oral tablet<br>* Other names: ASP1941;|
| Active Comparator: Metformin<br>oral tablet | Drug: Metformin<br>* oral tablet<br>|
| Placebo Comparator: Placebo<br>oral tablet | Drug: Placebo<br>* oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Hemoglobin A1c (HbA1c) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in fasting plasma glucose (FPG) |  | 12 weeks | 
| Proportion of subjects achieving target goal of HbA1c <7.0% |  | 12 weeks | 
| Proportion of subjects achieving target goal of HbA1c <6.5% |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASP1941, Metformin, Type 2 diabetes, diabetes