A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Part… (NCT03242018) | Clinical Trial Compass
CompletedPhase 3
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
United States277 participantsStarted 2017-08-16
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria :
* Participants with Type 2 Diabetes (drug-naĂ¯ve 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 t…
What they're measuring
1
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo