Phase 3
Completed N=787
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
Type 2 Diabetes Mellitus · Chronic Kidney Disease Stage 3
Source: ClinicalTrials.gov NCT03242252 ↗
Enrolled (actual)
787
Serious AEs
17.2%
Results posted
Jun 2021
Primary outcomePrimary: Change From Baseline in HbA1c at Week 26 — -0.22; -0.32; -0.46 percentage of HbA1c — p=0.2095
◆ Published Evidence
Established
46citations · ~15 / year
Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease.
Summary
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.
Linked Publications
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Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 26 |
-0.22; -0.32; -0.46 | 0.2095 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
-0.374; -0.961; -0.852 | 0.0144 sig |
| SECONDARY Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12 |
-5.18; -7.46; -7.71 | 0.2627 |
| SECONDARY Change From Baseline in SBP at Week 12 for All Participants |
-3.31; -4.91; -4.94 | 0.2212 |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
-0.38; -1.66; -1.20 | < 0.0001 sig |
| SECONDARY Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g) |
-18.71; -43.68; -48.12 | 0.0015 sig |
| SECONDARY Percentage of Participants With HbA1c <6.5% at Week 26 |
4.2; 5.7; 5.7 | 0.4328 |
| SECONDARY Percentage of Participants With HbA1c <7.0% at Week 26 |
13.5; 19.4; 20.8 | 0.0614 |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
78.1; 76.8; 74.2 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT03242252) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.