Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3

In brief

Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: * To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. * To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.

Key facts

Study ID

NCT03242252

Run by

Lexicon Pharmaceuticals

People needed

787

Starts

2017-08-16

Expected to finish

2019-10-25

Last updated by the study team

2021-06-25

Who can join

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

You may qualify if…

• Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30 and <60 milliliter per minute (mL/min)/1.73 meter square (m\^2) (chronic kidney disease [CKD] 3A, 3B).
• Participants has given written informed consent to participate in the study in accordance with local regulations.

You may not qualify if…

• Hemoglobin A1c (HbA1c) of <7.0% or >11.0%.
• Type 1 diabetes.
• 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 during the study.
• Treatment with a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin, Dapagliflozin, Empagliflozin) during the last 12 months.
• Uncontrolled high blood pressure.
• 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 or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
• Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.
• 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 8404045 — Guntersville, Alabama, United States
• Investigational Site Number 8404004 — Phoenix, Arizona, United States
• Investigational Site Number 8404022 — Phoenix, Arizona, United States
• Investigational Site Number 8404007 — Little Rock, Arkansas, United States
• Investigational Site Number 8404023 — Chula Vista, California, United States
• Investigational Site Number 8404044 — Gold River, California, United States
• Investigational Site Number 8404011 — Los Angeles, California, United States
• Investigational Site Number 8404003 — Norco, California, United States
• Investigational Site Number 8404025 — Northridge, California, United States
• Investigational Site Number 8404038 — San Dimas, California, United States
• Investigational Site Number 8404019 — Clearwater, Florida, United States
• Investigational Site Number 8404001 — DeLand, Florida, United States
• Investigational Site Number 8404006 — Ocoee, Florida, United States
• Investigational Site Number 8404064 — Orlando, Florida, United States
• Investigational Site Number 8404043 — Ormond Beach, Florida, United States
• Investigational Site Number 8404013 — Palmetto Bay, Florida, United States
• Investigational Site Number 8404016 — Savannah, Georgia, United States
• Investigational Site Number 8404040 — Wauconda, Illinois, United States
• Investigational Site Number 8404036 — Lake Charles, Louisiana, United States
• Investigational Site Number 8404020 — New Orleans, Louisiana, United States
• Investigational Site Number 8404014 — Norfolk, Nebraska, United States
• Investigational Site Number 8404032 — Papillion, Nebraska, United States
• Investigational Site Number 8404048 — Hackensack, New Jersey, United States
• Investigational Site Number 8404074 — New York, New York, United States
• Investigational Site Number 8404018 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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