Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

Primary Objective: To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter \[mg/dL\]). * To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants. * To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c. * To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. * To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.

Key facts

Study ID

NCT03332771

Run by

Lexicon Pharmaceuticals

People needed

954

Starts

2017-12-01

Expected to finish

2019-09-06

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 (T2D) treated with metformin at a stable dose ≥1500 milligrams per day (mg/day) or maximum tolerated dose (documented) for at least 12 weeks prior to Screening Visit; in case of documented lack of tolerance, metformin dose <1500 mg/day is acceptable, and the dose should be stable for at least 12 weeks prior to Screening Visit.
• Participants has given written informed consent to participate in the study in accordance with local regulations.

You may not qualify if…

• Age <18 years at the Screening Visit or <legal age of majority, whichever is greater.
• Type 1 diabetes mellitus.
• HbA1c, HbA1c <7.0% or HbA1c >10% at Screening.
• Fasting Plasma Glucose (FPG) >15 millimoles per liter (mmol/L) (>270 milligram 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.
• Body mass index ≤20 or >45 kilogram per meter square (kg/m\^2) at Screening.
• Pregnant (confirmed by pregnancy test at the Screening) or breast-feeding women.
• Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy (see Appendix A) during the study.
• Previous use of any antidiabetic drug other than Metformin within 12 weeks preceding the Screening Visit.
• Use of a selective Sodium-glucose co-transporter-2 (SGLT2) inhibitor (e.g., Canagliflozin, Dapagliflozin, or Empagliflozin) within 3 months prior to the Screening visit.
• Use of systemic glucocorticoids (excluding topical, or ophthalmic application, intra-articular, nasal spray or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
• Previous insulin use >1 month (at any time, except for treatment of gestational diabetes).
• History of prior gastric surgical procedure, including gastric banding, or inflammatory bowel disease within 3 years prior to the Screening Visit.
• Difficulty swallowing such that the participants cannot take the investigational medicinal product (IMP).
• History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
• Mean of 3 separate blood pressure measurements >180 millimeter of mercury (mmHg) (SBP) or >100 mmHg (DBP).
• History of hypertensive emergency within 12 weeks prior to Screening.
• Participants who have previously been randomized in any clinical trial of Sotagliflozin/LX4211.
• Participants with severe renal disease as defined by an estimated glomerular filtration rate (eGFR) of <30 milliliter per minute per meter square (mL/min/1.73 m\^2) at Screening, based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation (or according to the renal function restrictions of metformin use defined in the local approved label).
• Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease that, according to Investigator, will preclude their safe participation in this study, or will make 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 (ULN).
• Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome).
• Participants who have taken other investigational drugs within 12 weeks or 5 half-lives from Screening whichever is longer.
• Participants unwilling or unable to perform self-monitoring blood glucose (SMBG), complete the participant diary, or comply with study visits and other study procedures as required per protocol.
• Participants with contraindication to glimepiride as per local labelling.
• Participants with contraindication to metformin as per local labelling.

Where it is running

• Investigational Site Number 8407048 — Birmingham, Alabama, United States
• Investigational Site Number 8407035 — Little Rock, Arkansas, United States
• Investigational Site Number 8407051 — Anaheim, California, United States
• Investigational Site Number 8407065 — Canoga Park, California, United States
• Investigational Site Number 8407078 — Carmichael, California, United States
• Investigational Site Number 8407089 — Downey, California, United States
• Investigational Site Number 8407011 — Gold River, California, United States
• Investigational Site Number 8407044 — Greenbrae, California, United States
• Investigational Site Number 8407006 — Huntington Park, California, United States
• Investigational Site Number 8407037 — Lemon Grove, California, United States
• Investigational Site Number 8407100 — Lomita, California, United States
• Investigational Site Number 8407033 — Long Beach, California, United States
• Investigational Site Number 8407019 — Los Angeles, California, United States
• Investigational Site Number 8407098 — Northridge, California, United States
• Investigational Site Number 8407094 — Norwalk, California, United States
• Investigational Site Number 8407106 — Pomona, California, United States
• Investigational Site Number 8407096 — Rancho Cucamonga, California, United States
• Investigational Site Number 8407036 — Sacramento, California, United States
• Investigational Site Number 8407084 — Tarzana, California, United States
• Investigational Site Number 8407034 — Upland, California, United States
• Investigational Site Number 8407032 — Van Nuys, California, United States
• Investigational Site Number 8407004 — Walnut Creek, California, United States
• Investigational Site Number 8407117 — Wildomar, California, United States
• Investigational Site Number 8407045 — Colorado Springs, Colorado, United States
• Investigational Site Number 8407040 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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