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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

NCT03242252

CompletedPhase 3

Sponsor: Lexicon Pharmaceuticals

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

Interventions: Placebo, Sotagliflozin

Countries: United States, Argentina, Brazil, Canada, Colombia, Germany, Hungary, Israel

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria :

* 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.

Exclusion criteria:

* 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.

Locations (170)

Birmingham, Alabama, United States
Guntersville, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Chula Vista, California, United States
Gold River, California, United States
Los Angeles, California, United States
Norco, California, United States
Northridge, California, United States
San Dimas, California, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Ocoee, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Palmetto Bay, Florida, United States
Savannah, Georgia, United States
Wauconda, Illinois, United States
Lake Charles, Louisiana, United States
New Orleans, Louisiana, United States
Norfolk, Nebraska, United States
Papillion, Nebraska, United States
Hackensack, New Jersey, United States
New York, New York, United States
The Bronx, New York, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Winston-Salem, North Carolina, United States
Dayton, Ohio, United States
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