Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin. Secondary Objectives: * To compare Sotagliflozin 400 mg versus placebo based on: * 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 (mm Hg). * Change from baseline in SBP for all participants. * Change from baseline in body weight. * Percentage of participants with HbA1c \<6.5% and \<7.0%. * To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.

Key facts

Study ID

NCT03066830

Run by

Lexicon Pharmaceuticals

People needed

507

Starts

2017-02-24

Expected to finish

2019-04-30

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 T2D treated with a Sulfonylurea (≥half the maximum recommended dose as per local label or maximum tolerated dose [documented]) as monotherapy or in combination with Metformin (≥1500 mg per day or maximum tolerated dose [documented]) each at a stable dose for at least 12 weeks without a dose adjustment before screening.
• Signed written informed consent.

You may not qualify if…

• At the time of screening, age <18 years or < legal age of majority, whichever is greater.
• Body Mass Index (BMI) ≤20 or >45 kilograms per meter square (kg/m\^2) at Screening.
• Hemoglobin A1c (HbA1c) <7% or HbA1c >10% via central lab test at screening.
• Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
• Women of childbearing potential with no effective contraceptive method.
• Treated with an antidiabetic pharmacological regimen other than a Sulfonylurea at a stable dose with or without Metformin within 12 weeks preceding the screening visit.
• Previous insulin use >1 month (at any time, aside from treatment of gestational diabetes).
• History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit.
• History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
• History of severe hypoglycemia within 6 months prior to the Screening visit.
• Systolic blood pressure (SBP) >180 millimeter per mercury (mmHg) or diastolic blood pressure (DBP) >100 mmHg or history of hypertensive emergency.
• Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range (ULN).
• Total bilirubin: >1.5 times ULN (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.
• Pregnancy, breastfeeding.
• Participants is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the participant's diary as required per protocol.
• 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 8403018 — Peoria, Arizona, United States
• Investigational Site Number 8403009 — Greenbrae, California, United States
• Investigational Site Number 8403012 — Huntington Park, California, United States
• Investigational Site Number 8403019 — Los Angeles, California, United States
• Investigational Site Number 8403034 — Montclair, California, United States
• Investigational Site Number 8403016 — Spring Valley, California, United States
• Investigational Site Number 8403014 — Tustin, California, United States
• Investigational Site Number 8403001 — Northglenn, Colorado, United States
• Investigational Site Number 8403029 — Bradenton, Florida, United States
• Investigational Site Number 8403004 — New Port Richey, Florida, United States
• Investigational Site Number 8403020 — North Miami Beach, Florida, United States
• Investigational Site Number 8403026 — Ocoee, Florida, United States
• Investigational Site Number 8403032 — Orlando, Florida, United States
• Investigational Site Number 8403008 — Palm Harbor, Florida, United States
• Investigational Site Number 8403006 — Pembroke Pines, Florida, United States
• Investigational Site Number 8403013 — Port Charlotte, Florida, United States
• Investigational Site Number 8403007 — Nampa, Idaho, United States
• Investigational Site Number 8403011 — Flint, Michigan, United States
• Investigational Site Number 8403025 — Richfield, Minnesota, United States
• Investigational Site Number 8403021 — Henderson, Nevada, United States
• Investigational Site Number 8403028 — Greensboro, North Carolina, United States
• Investigational Site Number 8403015 — Shelby, North Carolina, United States
• Investigational Site Number 8403033 — Hatboro, Pennsylvania, United States
• Investigational Site Number 8403030 — Kingsport, Tennessee, United States
• Investigational Site Number 8403003 — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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