Summary:
To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise. Qualified trial participants will be placed on a an investigational drug and will be asked to make 10 visits to the trial doctor over 26 weeks.
Inclusion criteria :
- Patients (male and female) with T2D, who are treated with diet and exercise only during the 12 weeks prior to screening
Exclusion criteria:
- Body Mass Index (BMI) ≤20 or >45 kg/m2 at Screening
- Hemoglobin A1c <7% or >10% via central laboratory test at Screening.
- Treated with an antidiabetic medication within the 12 weeks prior to the Screening Visit.
- Previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes).
- History of gastric surgical procedure including gastric banding within 3 years before the Screening Visit.
- Patients with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association [NYHA] IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
- Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
- Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.
- Patient is unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the patient diary, or comply with study visits and other study procedures as required per protocol.
- Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.
Qualified Participants May Receive:
Patients will receive trial-related care and medications at no charge as well as a travel stipend for each completed visit.