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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:12/27/2017
Start Date:March 2015
End Date:February 2017

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A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin High dose
or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when
used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate
glycemic control with insulin therapy.


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 T1D made at least 1 year prior
to informed consent

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

- Willing and able to perform 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
randomization

- Chronic systemic corticosteroid use

- Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the
Investigator
We found this trial at
65
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Little Rock, Arkansas 72211
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Albany, New York 12206
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Asheville, North Carolina 28803
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Atlanta, Georgia 30318
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Aurora, Colorado 80045
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Austin, Texas 78749
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Baltimore, Maryland 21204
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Bangor, Maine 04401
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Birmingham, Alabama 35294
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Boston, Massachusetts 02215
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Calgary, Alberta
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Chapel Hill, North Carolina 27517
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Chattanooga, Tennessee 37421
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Chattanooga, Tennessee 37421
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Chesapeake, Virginia 23321
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Chesterfield, Missouri 63017
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Columbus, Ohio 43201
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Crystal Lake, Illinois 60012
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Dallas, Texas 75230
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Dallas, Texas 75230
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Dallas, Texas 75230
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Detroit, Michigan 46214
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Elgin, Illinois 60123
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Escondido, California 92025
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Fleming Island, Florida 32003
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Greenbrae, California 94904
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Greer, South Carolina 29651
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Henderson, Nevada 89052
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Honolulu, Hawaii 96814
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Houston, Texas 77030
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Houston, Texas 77030
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Huntington Beach, California 92648
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Jacksonville, Florida 32258
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Jacksonville, Florida 32258
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La Jolla, California 92037
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Las Vegas, Nevada 89148
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Lawrenceville, Georgia 30046
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Lexington, Kentucky 40536
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Longmont, Colorado 80501
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Los Angeles, California 90057
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Memphis, Tennessee 38119
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Milwaukee, Wisconsin 53209
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Morehead City, North Carolina 28557
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New Port Richey, Florida 34652
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New York, New York 10029
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Oklahoma City, Oklahoma 73112
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Omaha, Nebraska 68114
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Orange, California 92868
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Ormond Beach, Florida 32174
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Palm Springs, California 92262
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Portland, Oregon 97239
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Rapid City, South Dakota 57701
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Renton, Washington 98057
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Roswell, Georgia 30076
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Saint Louis, Missouri 63110
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San Antonio, Texas 78209
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San Mateo, California 94401
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Schertz, Texas 78154
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Seattle, Washington 98195
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Springfield, Illinois 62711
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Tarzana, California 91356
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Topeka, Kansas 66606
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Tustin, California 92780
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Walnut Creek, California 94598
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