Sotagliflozin

Generic Name
Sotagliflozin
Brand Names
Inpefa
Drug Type
Small Molecule
Chemical Formula
C21H25ClO5S
CAS Number
1018899-04-1
Unique Ingredient Identifier
6B4ZBS263Y
Background

Sotagliflozin is a dual inhibitor of SGLT1 and SGLT2, the first of its kind, which is approved for use in the EU, in combination with insulin, to improve glycemic control in patients with type 1 diabetes mellitus (T1DM) and a BMI ≥27 kg/m. Its potency in inhibiting SGLT2 is similar to that of other SGLT2 inhibitors, such as canagliflozin and dapagliflozin, b...

Indication

用于体重指数≥27kg/m2且接受最佳胰岛素疗法仍无法达到足够血糖控制的1型糖尿病(T1D)成人患者。

Associated Conditions
Cardiovascular Mortality, Heart Failure
Associated Therapies
-

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

First Posted Date
2015-08-21
Last Posted Date
2020-02-12
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
1405
Registration Number
NCT02531035
Locations
🇬🇧

Lexicon Investigational Site, Northampton, United Kingdom

Oral Contraceptive DDI Study

First Posted Date
2015-07-10
Last Posted Date
2016-03-02
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
30
Registration Number
NCT02494609
Locations
🇺🇸

Lexicon Investigational Site, Dallas, Texas, United States

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-06-15
Last Posted Date
2016-11-17
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
32
Registration Number
NCT02471274
Locations
🇺🇸

Lexicon Investigational Site, Minneapolis, Minnesota, United States

Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-06-02
Last Posted Date
2020-02-12
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
141
Registration Number
NCT02459899
Locations
🇺🇸

Lexicon Investigational Site, Manassas, Virginia, United States

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-04-20
Last Posted Date
2020-02-12
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
782
Registration Number
NCT02421510
Locations
🇬🇧

Lexicon Investigational Site, Sheffield, United Kingdom

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-03-10
Last Posted Date
2020-02-12
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
793
Registration Number
NCT02384941
Locations
🇨🇦

Lexicon Investigational Site, St. Laurent, Quebec, Canada

Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-03-10
Last Posted Date
2020-02-12
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
87
Registration Number
NCT02383940
Locations
🇺🇸

Lexicon Investigational Site, Salt Lake City, Utah, United States

Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-12-05
Last Posted Date
2020-02-12
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
36
Registration Number
NCT01742208
Locations
🇺🇸

Lexicon Investigational Site, Dallas, Texas, United States

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