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Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin
Phase 3 trial testing Sotagliflozin in Type 2 Diabetes Mellitus in 770 participants. Completed in 16 May 2019.
| Lead sponsor | Lexicon Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 770 |
| Start date | 27 November 2017 |
| Primary completion | 16 May 2019 |
| Estimated completion | 16 May 2019 |
| Sites | 160 locations across France, Italy, Slovakia, Russia, United Kingdom, Mexico, Canada, Bulgaria |
Lexicon Pharmaceuticals — full company profile →
18 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
An analysis of covariance (ANCOVA) model was used for the analysis.
| Group | Value | 95% CI |
|---|---|---|
| Sotagliflozin 400 mg | -0.7 | ± 0.1 |
| Empagliflozin 25 mg | -0.8 | ± 0.1 |
| Placebo | -0.3 | ± 0.1 |
An ANCOVA model was used for the analysis.
| Group | Value | 95% CI |
|---|---|---|
| Sotagliflozin 400 mg | -5.6 | ± 1.3 |
| Empagliflozin 25 mg | -6.7 | ± 1.3 |
| Placebo | -3.5 | ± 1.5 |
An ANCOVA model was used for the analysis.
| Group | Value | 95% CI |
|---|---|---|
| Sotagliflozin 400 mg | -1.3 | ± 0.2 |
| Empagliflozin 25 mg | -1.2 | ± 0.9 |
| Placebo | -0.4 | ± 0.2 |
An ANCOVA model was used for the analysis.
| Group | Value | 95% CI |
|---|---|---|
| Sotagliflozin 400 mg | -1.3 | ± 0.2 |
| Empagliflozin 25 mg | -1.6 | ± 0.2 |
| Placebo | -0.5 | ± 0.2 |
An ANCOVA model was used for the analysis.
| Group | Value | 95% CI |
|---|---|---|
| Sotagliflozin 400 mg | -2.7 | ± 0.3 |
| Empagliflozin 25 mg | -3.2 | ± 0.3 |
| Placebo | -0.5 | ± 0.3 |
An ANCOVA model was used for the analysis.
| Group | Value | 95% CI |
|---|---|---|
| Sotagliflozin 400 mg | -1.7 | ± 0.8 |
| Empagliflozin 25 mg | -2.8 | ± 0.8 |
| Placebo | -0.4 | ± 1.0 |
| Group | Value | 95% CI |
|---|---|---|
| Sotagliflozin 400 mg | 12.1 | |
| Empagliflozin 25 mg | 11.7 | |
| Placebo | 3.9 |
| Group | Value | 95% CI |
|---|---|---|
| Sotagliflozin 400 mg | 32.6 | |
| Empagliflozin 25 mg | 35.6 | |
| Placebo | 15.6 |
Time frame: First dose of study drug to last dose of study drug (up to 26 weeks) + 4 weeks (Approximately 30 weeks). Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Sotagliflozin 400 mg | Empagliflozin 25 mg | Placebo |
|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | — | — | — |
| Diverticulum intestinal | Gastrointestinal disorders | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
| Hypertensive crisis | Vascular disorders | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — |
| Sinus node dysfunction | Cardiac disorders | — | — | — |
| Right ventricular failure | Cardiac disorders | — | — | — |
| Myocardial fibrosis | Cardiac disorders | — | — | — |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Nasal cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Abdominal lymphadenopathy | Blood and lymphatic system disorders | — | — | — |
| Cerebral haematoma | Nervous system disorders | — | — | — |
| Cerebral ischaemia | Nervous system disorders | — | — | — |
| Ischaemic stroke | Nervous system disorders | — | — | — |
| Presyncope | Nervous system disorders | — | — | — |
| Umbilical hernia | Gastrointestinal disorders | — | — | — |
| Reaction | System | Sotagliflozin 400 mg | Empagliflozin 25 mg | Placebo |
|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Vulvovaginal mycotic infection | Infections and infestations | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — |
| Any Hypoglycaemia | Metabolism and nutrition disorders | — | — | — |
| Influenza | Infections and infestations | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Documented Symptomatic Hypoglycaemia | Metabolism and nutrition disorders | — | — | — |
| Genital infection fungal | Infections and infestations | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
Most-reported serious reactions: Cerebrovascular accident, Diverticulum intestinal, Pneumonia, Lumbar vertebral fracture, Hypotension, Hypertensive crisis, Atrial flutter, Sinus node dysfunction.
Data from ClinicalTrials.gov NCT03351478 adverse events section.
The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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