Phase 3
Completed N=277
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
Type 2 Diabetes Mellitus · Chronic Kidney Disease Stage 4
Source: ClinicalTrials.gov NCT03242018 ↗
Enrolled (actual)
277
Serious AEs
21.3%
Results posted
Jun 2021
Primary outcomePrimary: Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo — -0.11; -0.40 percentage of HbA1c — p=0.0962
◆ Published Evidence
Established
63citations · ~13 / year
Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment.
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
Linked Publications (2)
-
Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment.
-
Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo |
-0.11; -0.40 | 0.0962 |
| SECONDARY Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo |
-0.11; -0.07 | 0.8124 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
0.069; -0.291; -0.644 | 0.5501 |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
0.39; -0.43; -1.02 | 0.2432 |
| SECONDARY Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg |
-2.70; -4.84; -7.10 | 0.3954 |
| SECONDARY Change From Baseline in SBP at Week 12 for All Participants |
-2.50; -5.74; -7.86 | 0.1232 |
| 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) |
-4.56; -26.99; -30.66 | 0.222 |
| SECONDARY Percentage of Participants With HbA1c <6.5% at Week 26 |
2.2; 5.4; 8.7 | 0.2420 |
| SECONDARY Percentage of Participants With HbA1c <7.0% at Week 26 |
4.3; 16.3; 17.4 | 0.0066 sig |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
82.8; 86.2; 81.1 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT03242018) 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.