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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 30
Updated:12/27/2017
Start Date:April 2015
End Date:September 2016

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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX4211 in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

This Phase 2 study is intended to demonstrate superiority of Sotagliflozin versus placebo on
A1C reduction at Week 12 in young adult patients with T1DM who have poor glycemic control on
their current insulin regimen.


Inclusion Criteria:

- Patient has given written informed consent

- Young adult patients ≥18 to ≤30 years old at Screening, with a confirmed diagnosis of
T1DM made at least 1 year prior to informed consent

- Patients are being treated with insulin or insulin analogue delivered via CSII or MDI

- At Screening, must have A1C ≥9.0%

- Must be willing and able to perform SMBG and complete the study diary

- Females of childbearing potential must use an adequate method of contraception and
have a negative pregnancy test

Exclusion Criteria:

- Any prior use of LX4211/Sotagliflozin

- Use of antidiabetic agent other than insulin or insulin analogue at the time of
screening

- Use of SGLT inhibitors within 8 weeks prior to start of the placebo Run-in Period

- Chronic systemic corticosteroid use

- Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the
Investigator

- History of DKA or nonketotic hyperosmolar state within 6 months prior to the Screening
Visit

- History of severe hypoglycemic event within 1 month prior to Screening Visit
We found this trial at
15
sites
Atlanta, Georgia 30318
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Auburn, Maine 04210
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Auburn, ME
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Aurora, Colorado 80045
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Aurora, CO
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Austin, Texas 78749
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Austin, TX
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Boston, Massachusetts 02215
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Boston, MA
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Buffalo, New York 14263
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Buffalo, NY
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Indianapolis, Indiana 46202
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Indianapolis, IN
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New Haven, Connecticut 06519
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New Haven, CT
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New Orleans, Louisiana 70121
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New Orleans, LA
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Roswell, Georgia 30076
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Roswell, GA
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Salt Lake City, Utah 84107
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Salt Lake City, UT
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Tampa, Florida 33612
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Tampa, FL
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Tustin, California 92780
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Tustin, CA
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West Palm Beach, Florida 33401
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West Palm Beach, FL
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Wilmington, North Carolina 28401
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Wilmington, NC
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