Phase 3
Completed N=954
Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
Source: ClinicalTrials.gov NCT03332771 ↗Enrolled (actual)
954
Serious AEs
5.6%
Results posted
May 2021
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c at Week 52 — -0.40; -0.65; -0.49; -0.61 percentage of HbA1c — p=0.3306
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Primary Objective:
To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin.
Secondary Objectives:
To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter [mg/dL]).
* To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants.
* To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c.
* To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
* To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c.
* To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c at Week 52 |
-0.40; -0.65; -0.49; -0.61 | 0.3306 |
| SECONDARY Change From Baseline in Hemoglobin A1c at Week 26 |
-0.41; -0.77; -0.61; -1.02 | 0.0827 |
| SECONDARY Change From Baseline in Body Weight at Week 26 and 52 |
-1.26; -2.75; -2.24; 0.70; -0.47; -2.64 | <0.0001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) for Participants With SBP ≥130 mmHg at Week 12 |
-5.34; -8.03; -9.12; -3.86 | 0.0012 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) for All Participants at Week 12 |
-2.64; -4.70; -4.77; -0.68 | <0.0001 sig |
| SECONDARY Percentage of Participants With At Least One Documented Symptomatic Hypoglycemic Event |
0.63; 1.26; 3.75; 16.67 | <0.0001 sig |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
57.2; 59.9; 56.6; 49.2 | — |
Eligibility Criteria
Inclusion criteria
- Participants with Type 2 Diabetes (T2D) treated with metformin at a stable dose ≥1500 milligrams per day (mg/day) or maximum tolerated dose (documented) for at least 12 weeks prior to Screening Visit; in case of documented lack of tolerance, metformin dose 10% at Screening.
- Fasting Plasma Glucose (FPG) >15 millimoles per liter (mmol/L) (>270 milligram per deciliter [mg/dL]) measured by the central laboratory at Screening (Visit 1) and confirmed by a repeat test (>15 mmol/L [>270 mg/dL]) before randomization.
- Body mass index ≤20 or >45 kilogram per meter square (kg/m^2) at Screening.
- Pregnant (confirmed by pregnancy test at the Screening) or breast-feeding women.
- 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 (see Appendix A) during the study.
- Previous use of any antidiabetic drug other than Metformin within 12 weeks preceding the Screening Visit.
- Use of a selective Sodium-glucose co-transporter-2 (SGLT2) inhibitor (e.g., Canagliflozin, Dapagliflozin, or Empagliflozin) within 3 months prior to the Screening visit.
- Use of systemic glucocorticoids (excluding topical, or ophthalmic application, intra-articular, nasal spray or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
- Previous insulin use >1 month (at any time, except for treatment of gestational diabetes).
- History of prior gastric surgical procedure, including gastric banding, or inflammatory bowel disease within 3 years prior to the Screening Visit.
- Difficulty swallowing such that the participants cannot take the investigational medicinal product (IMP).
- History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
- Mean of 3 separate blood pressure measurements >180 millimeter of mercury (mmHg) (SBP) or >100 mmHg (DBP).
- History of hypertensive emergency within 12 weeks prior to Screening.
- Participants who have previously been randomized in any clinical trial of Sotagliflozin/LX4211.
- Participants with severe renal disease as defined by an estimated glomerular filtration rate (eGFR) of 3 times the upper limit of the normal laboratory range (ULN).
- Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome).
- Participants who have taken other investigational drugs within 12 weeks or 5 half-lives from Screening whichever is longer.
- Participants unwilling or unable to perform self-monitoring blood glucose (SMBG), complete the participant diary, or comply with study visits and other study procedures as required per protocol.
- Participants with contraindication to glimepiride as per local labelling.
- Participants with contraindication to metformin as per local labelling.
The above information is not intended to contain all considerations relevant to a Participants potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03332771). 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.