A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadaquate Glycemic Control With Insulin Therapy Alone (inTandem3)
Investigator: Mary F. Carroll, MD
Status: Recruiting
Phase: 3
Sponsor: Lexicon Pharmaceuticals
Contact: Alisa Huson, 541-706-6592 or ahuson@bmctotalcare.com
Location: Bend, Oregon (Central Oregon)
Purpose: This Phase 3 study is designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with T1D.
Inclusion Criteria:
- Patient has given written informed consent to participate in the study in accordance with local regulations
- Adult patients 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
- Patients are 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 must be between 7.0% to 11.0%
- Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test
Exclusion Criteria:
- 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
See this trial at ClinicalTrials.gov
For general inquiries, please contact the BMC Research Department at research@bmctotalcare.com or 877-692-8338.
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