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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lexicon Pharmaceuticals
With
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants had given written informed consent to participate in the study in accordance with local regulations
Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
Participants were being treated with insulin or insulin analog
Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
At the Screening Visit, A1C was between 7.0% to 11.0%
Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test
You may not be if
Use of antidiabetic agent other than insulin or insulin analog at the time of screening
Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening
Chronic systemic corticosteroid use
Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator
Clareo Health | 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
