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Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

NCT02926950

CompletedPhase 3

Sponsor: Lexicon Pharmaceuticals

Conditions: Type 2 Diabetes Mellitus

Interventions: Sotagliflozin (SAR439954), Placebo, Metformin

Countries: United States, Canada, Hungary, Slovakia

Primary Objective: To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: * To compare Sotagliflozin versus placebo for. * Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal. * Change from baseline in fasting plasma glucose (FPG). * Change from Baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mmHg). * Change from baseline in SBP for all participants. * Change from baseline in body weight. * Proportion of participants with HbA1c \<6.5% and \<7.0%. * To evaluate the safety of Sotagliflozin versus placebo.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria :

* Participants with Type 2 Diabetes currently treated with diet and exercise and on metformin at a stable dose ≥1500 milligrams per day (mg/day) for at least 12 weeks. However, participants on metformin at a dose \<1500 mg/day at the time of enrollment (stable dose for at least 12 weeks before enrollment) may be eligible for screening if documentation of lack of tolerance of a metformin dose ≥1500 mg/day can be provided.
* Signed written informed consent.

Exclusion criteria:

* Age \<18 years at Screening or \< legal age of majority, whichever is greater.
* Type 1 diabetes mellitus.
* Body Mass Index (BMI) ≤20 or \>45 kilograms per meter square (kg/m\^2) at Screening
* Hemoglobin A1c \<7% or \>10% via central laboratory test at screening.
* Fasting plasma glucose (FPG) \>15 millimole per liter (mmol/L) (270 milligrams per deciliter \[mg/dL\]) measured by the central laboratory at screening (Visit 1) and confirmed by a repeat test (\>15 mmol/L \[270 mg/dL\]) before randomization.
* Women of childbearing potential not willing to use highly effective method(s) of birth control or who are unwilling or unable to be tested for pregnancy during the study.
* Treated with an antidiabetic pharmacological regimen other than metformin ≥1500 mg per day (or maximum tolerated dose) within the 12 weeks preceding the Screening Visit.
* Previous use of any types of insulin for \>1 month (at any time, aside from pregnancy for treatment of gestational diabetes).
* History of prior gastric surgical procedure, including gastric banding, within 3 years before the Screening Visit.
* History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
* Mean of 3 separate blood pressure measurements \>180 mmHg (SBP) or \>100 mmHg (diastolic blood pressure \[DBP\]).
* History of hypertensive urgency or emergency within 12 weeks prior to Screening.
* Participants 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 participants with short life expectancy making implementation of the protocol or interpretation of the study results difficult.
* Aspartate aminotransferase and/or alanine aminotransferase: \>3 times the upper limit of the normal laboratory range.
* Total bilirubin: \>1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome).
* 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.
* Participants who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives from screening or randomization, whichever is longer.
* Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.
* Participants is unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the participants diary, or comply with study visits and other study procedures as required per protocol.
* Contraindication to metformin as per local labelling.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations (93)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Canoga Park, California, United States
Escondido, California, United States
Gold River, California, United States
Greenbrae, California, United States
Huntington Park, California, United States
La Mirada, California, United States
Lemon Grove, California, United States
Lincoln, California, United States
Long Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Ramon, California, United States
Tarzana, California, United States
Boynton Beach, Florida, United States
Daytona Beach, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
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