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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
Phase 3 trial testing Placebo in Type 2 Diabetes Mellitus in 787 participants. Completed in 25 October 2019.
| Lead sponsor | Lexicon Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 787 |
| Start date | 16 August 2017 |
| Primary completion | 25 March 2019 |
| Estimated completion | 25 October 2019 |
| Sites | 170 locations across Italy, Colombia, South Africa, Russia, Ukraine, Germany, Hungary, Israel |
Lexicon Pharmaceuticals — full company profile →
18 and older, any sex, with Type 2 Diabetes Mellitus or Chronic Kidney Disease Stage 3. 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 analysis.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.22 | ± 0.061 |
| Sotagliflozin 200 mg | -0.32 | ± 0.060 |
| Sotagliflozin 400 mg | -0.46 | ± 0.060 |
An ANCOVA model was used for analysis.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.374 | ± 0.1949 |
| Sotagliflozin 200 mg | -0.961 | ± 0.1715 |
| Sotagliflozin 400 mg | -0.852 | ± 0.1668 |
An ANCOVA model was used for analysis.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -5.18 | ± 1.462 |
| Sotagliflozin 200 mg | -7.46 | ± 1.597 |
| Sotagliflozin 400 mg | -7.71 | ± 1.247 |
An ANCOVA model was used for analysis.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -3.31 | ± 1.037 |
| Sotagliflozin 200 mg | -4.91 | ± 1.010 |
| Sotagliflozin 400 mg | -4.94 | ± 0.983 |
An ANCOVA model was used for analysis.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.38 | ± 0.262 |
| Sotagliflozin 200 mg | -1.66 | ± 0.246 |
| Sotagliflozin 400 mg | -1.20 | ± 0.257 |
An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -18.71 | ± NA |
| Sotagliflozin 200 mg | -43.68 | ± NA |
| Sotagliflozin 400 mg | -48.12 | ± NA |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 4.2 | |
| Sotagliflozin 200 mg | 5.7 | |
| Sotagliflozin 400 mg | 5.7 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 13.5 | |
| Sotagliflozin 200 mg | 19.4 | |
| Sotagliflozin 400 mg | 20.8 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 78.1 | |
| Sotagliflozin 200 mg | 76.8 | |
| Sotagliflozin 400 mg | 74.2 |
Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other res
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 38.1 | |
| Sotagliflozin 200 mg | 41.9 | |
| Sotagliflozin 400 mg | 35.4 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 26.9 | |
| Sotagliflozin 200 mg | 29.6 | |
| Sotagliflozin 400 mg | 22.3 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 26.9 | |
| Sotagliflozin 200 mg | 29.6 | |
| Sotagliflozin 400 mg | 22.3 |
Time frame: Up to 60 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Sotagliflozin 200 mg | Sotagliflozin 400 mg |
|---|---|---|---|---|
| Angina unstable | Cardiac disorders | — | — | — |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Peripheral artery stenosis | Vascular disorders | — | — | — |
| Peripheral ischaemia | Vascular disorders | — | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — | — |
| Cardiac failure chronic | Cardiac disorders | — | — | — |
| Coronary artery disease | Cardiac disorders | — | — | — |
| Hypoglycaemic unconsciousness | Nervous system disorders | — | — | — |
| Ischaemic stroke | Nervous system disorders | — | — | — |
| Large intestine polyp | Gastrointestinal disorders | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — |
| Chronic kidney disease | Renal and urinary disorders | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — | — |
| Abscess limb | Infections and infestations | — | — | — |
| Appendicitis | Infections and infestations | — | — | — |
| Gangrene | Infections and infestations | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Deep vein thrombosis | Vascular disorders | — | — | — |
| Extremity necrosis | Vascular disorders | — | — | — |
| Femoral artery aneurysm | Vascular disorders | — | — | — |
| Reaction | System | Placebo | Sotagliflozin 200 mg | Sotagliflozin 400 mg |
|---|---|---|---|---|
| Vitamin D deficiency | Metabolism and nutrition disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — |
Most-reported serious reactions: Angina unstable, Basal cell carcinoma, Myocardial infarction, Cerebrovascular accident, Urinary tract infection, Peripheral artery stenosis, Peripheral ischaemia, Acute myocardial infarction.
Data from ClinicalTrials.gov NCT03242252 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing