A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe 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 4

In brief

Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: * To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c * To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo * To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

Key facts

Study ID

NCT03242018

Run by

Lexicon Pharmaceuticals

People needed

277

Starts

2017-08-16

Expected to finish

2019-12-11

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 severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD) equation) of ≥15 and <30 milliliter per minute (mL/min)/1.73 per meter square (m\^2).
• Signed written informed consent to participate in the study in accordance with local regulations.

You may not qualify if…

• At the time of screening, age <18 years.
• Hemoglobin A1c (HbA1c) <7% or >11%.
• 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 an sodium-glucose cotransporter type 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
• Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy, 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 8405005 — Phoenix, Arizona, United States
• Investigational Site Number 8405007 — Little Rock, Arkansas, United States
• Investigational Site Number 8405015 — Chula Vista, California, United States
• Investigational Site Number 8405032 — La Jolla, California, United States
• Investigational Site Number 8405003 — Norco, California, United States
• Investigational Site Number 8405013 — Northridge, California, United States
• Investigational Site Number 8405018 — San Dimas, California, United States
• Investigational Site Number 8405021 — Clearwater, Florida, United States
• Investigational Site Number 8405001 — DeLand, Florida, United States
• Investigational Site Number 8405043 — Miami, Florida, United States
• Investigational Site Number 8405006 — Ocoee, Florida, United States
• Investigational Site Number 8405025 — Ormond Beach, Florida, United States
• Investigational Site Number 8405039 — Lawrenceville, Georgia, United States
• Investigational Site Number 8405041 — Arlington Heights, Illinois, United States
• Investigational Site Number 8405030 — Sellersburg, Indiana, United States
• Investigational Site Number 8405019 — Lake Charles, Louisiana, United States
• Investigational Site Number 8405034 — Flint, Michigan, United States
• Investigational Site Number 8405012 — Norfolk, Nebraska, United States
• Investigational Site Number 8405035 — Albany, New York, United States
• Investigational Site Number 8405027 — Laurelton, New York, United States
• Investigational Site Number 8405014 — The Bronx, New York, United States
• Investigational Site Number 8405037 — New Bern, North Carolina, United States
• Investigational Site Number 8405038 — Winston-Salem, North Carolina, United States
• Investigational Site Number 8405009 — Dayton, Ohio, United States
• Investigational Site Number 8405033 — Guntersville, Alabama, United States

Full record on ClinicalTrials.gov

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