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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02926950

Run by

Lexicon Pharmaceuticals

People needed

518

Starts

2016-11-01

Expected to finish

2019-03-22

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 8402017 — Birmingham, Alabama, United States
• Investigational Site Number 8402052 — Phoenix, Arizona, United States
• Investigational Site Number 8402056 — Canoga Park, California, United States
• Investigational Site Number 8402020 — Escondido, California, United States
• Investigational Site Number 8402028 — Gold River, California, United States
• Investigational Site Number 8402067 — Greenbrae, California, United States
• Investigational Site Number 8402025 — Huntington Park, California, United States
• Investigational Site Number 8402051 — La Mirada, California, United States
• Investigational Site Number 8402042 — Lemon Grove, California, United States
• Investigational Site Number 8402011 — Lincoln, California, United States
• Investigational Site Number 8402014 — Long Beach, California, United States
• Investigational Site Number 8402066 — Long Beach, California, United States
• Investigational Site Number 8402029 — Los Angeles, California, United States
• Investigational Site Number 8402041 — Los Angeles, California, United States
• Investigational Site Number 8402001 — Los Angeles, California, United States
• Investigational Site Number 8402043 — San Diego, California, United States
• Investigational Site Number 8402031 — San Ramon, California, United States
• Investigational Site Number 8402047 — Tarzana, California, United States
• Investigational Site Number 8402009 — Boynton Beach, Florida, United States
• Investigational Site Number 8402016 — Daytona Beach, Florida, United States
• Investigational Site Number 8402006 — Hialeah, Florida, United States
• Investigational Site Number 8402035 — Hialeah, Florida, United States
• Investigational Site Number 8402044 — Hialeah, Florida, United States
• Investigational Site Number 8402045 — Jacksonville, Florida, United States
• Investigational Site Number 8402003 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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