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 (SOTA-CKD4)

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease Stage 4

Treatments: Drug: Sotagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03242018

U1111-1190-7589 (Other Identifier)

2016-004906-32

EFC15166

Details and patient eligibility

About

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

Full description

The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment and a visit 4 weeks after completion of the randomized treatment period.

Enrollment: 277 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• 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.

Exclusion criteria:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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277 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 milligrams \[mg\] in appearance) orally once daily for up to 56 weeks.

Treatment:

Drug: Placebo

Sotagliflozin 200 mg

Experimental group

Description:

Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 56 weeks.

Treatment:

Drug: Placebo

Drug: Sotagliflozin

Sotagliflozin 400 mg

Experimental group

Description:

Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56 weeks.

Treatment:

Drug: Sotagliflozin