Last updated on May 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: NIDDM
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion criteria :

  • Patients with Type 2 Diabetes (T2D) treated with metformin at a stable dose 1500 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.
  • Patient has given written informed consent to participate in the study in accordance with local regulations..

Exclusion criteria:

  • Age <18 years at the Screening Visit or <legal age of majority, whichever is greater.
  • Type 1 diabetes mellitus.
  • HbA1c <7.0% or HbA1c >10% at Screening.
  • Fasting Plasma Glucose (FPG) >15 mmol/L (>270 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 kg/m 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 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 patient 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 mmHg (SBP) or >100 mmHg (DBP).
  • History of hypertensive emergency within 12 weeks prior to Screening.
  • Patients who have previously been randomized in any clinical trial of sotagliflozin/LX4211.
  • Patients with severe renal disease as defined by an eGFR of <30 mL/min/1.73 m 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).
  • Patients 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).
  • Patients who have taken other investigational drugs within 12 weeks or 5 half-lives from Screening whichever is longer.
  • Patients unwilling or unable to perform self-monitoring blood glucose (SMBG), complete the patient diary, or comply with study visits and other study procedures as required per protocol.
  • Patients with contraindication to glimepiride as per local labeling.
  • Patients with contraindication to metformin as per local labeling.

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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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