Clinical trial NCT02384941: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2015-03-10
Enrollment: 793
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 3 study was 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 participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.


Eligibility criteria: Inclusion Criteria:

* 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 T1D made at least 1 year prior to informed consent.
* Participants were being treated with insulin or insulin analog delivered. via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* Willing and able to perform self-monitored 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 randomization.
* Chronic systemic corticosteroid use.
* Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator.

Primary outcomes:
measure: Change From Baseline in A1C at Week 24
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Percentage of Participants With A1C <7.0% (at Week 24) and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) Upto Week 24
timeFrame: Baseline to Week 24
measure: Absolute Change From Baseline in Body Weight at Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in Diabetes Total Treatment Satisfaction Scores as Measured by Total Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Scores at Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in Diabetes Distress Scores as Measured by 2-item Diabetes Distress Screening Scale (DDS2) Scores at Week 24
timeFrame: Baseline to Week 24
measure: Percent Change From Baseline in Body Weight at Week 24
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lexicon Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Lexicon Investigational Site
state: Arkansas
city: Escondido
country: United States
facility: Lexicon Investigational Site
state: California
city: Greenbrae
country: United States
facility: Lexicon Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Lexicon Investigational Site
state: California
city: La Jolla
country: United States
facility: Lexicon Investigational Site
state: California
city: Los Angeles
country: United States
facility: Lexicon Investigational Site
state: California
city: Orange
country: United States
facility: Lexicon Investigational Site
state: California
city: Palm Springs
country: United States
facility: Lexicon Investigational Site
state: California
city: San Mateo
country: United States
facility: Lexicon Investigational Site
state: California
city: Tarzana
country: United States
facility: Lexicon Investigational Site
state: California
city: Tustin
country: United States
facility: Lexicon Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Lexicon Investigational Site
state: California
city: Aurora
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: Longmont
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: Fleming Island
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Lexicon Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Lexicon Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Lexicon Investigational Site
state: Hawaii
city: Crystal Lake
country: United States
facility: Lexicon Investigational Site
state: Illinois
city: Elgin
country: United States
facility: Lexicon Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Lexicon Investigational Site
state: Illinois
city: Topeka
country: United States
facility: Lexicon Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Lexicon Investigational Site
state: Kentucky
city: Bangor
country: United States
facility: Lexicon Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Lexicon Investigational Site
state: Maryland
city: Boston
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Lexicon Investigational Site
state: Michigan
city: Chesterfield
country: United States
facility: Lexicon Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Lexicon Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Lexicon Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Lexicon Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Lexicon Investigational Site
state: Nevada
city: Albany
country: United States
facility: Lexicon Investigational Site
state: New York
city: New York
country: United States
facility: Lexicon Investigational Site
state: New York
city: Asheville
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Lexicon Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Lexicon Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Lexicon Investigational Site
state: Oregon
city: Greer
country: United States
facility: Lexicon Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: Lexicon Investigational Site
state: South Dakota
city: Chattanooga
country: United States
facility: Lexicon Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Lexicon Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Lexicon Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Houston
country: United States
facility: Lexicon Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Schertz
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Chesapeake
country: United States
facility: Lexicon Investigational Site
state: Virginia
city: Renton
country: United States
facility: Lexicon Investigational Site
state: Washington
city: Seattle
country: United States
facility: Lexicon Investigational Site
state: Washington
city: Calgary
country: Canada
facility: Lexicon Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Lexicon Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Lexicon Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: Lexicon Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Lexicon Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Lexicon Investigational Site
state: Ontario
city: London
country: Canada
facility: Lexicon Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Lexicon Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: Lexicon Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Lexicon Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Lexicon Investigational Site
state: Quebec
city: St. Laurent
country: Canada
facility: Lexicon Investigational Site
state: Quebec
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Sangeeta Sawhney, M.D.
role: STUDY_DIRECTOR
References:
citation: Peters AL, McGuire DK, Danne T, Kushner JA, Rodbard HW, Dhatariya K, Sawhney S, Banks P, Jiang W, Davies MJ, Lapuerta P. Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies. Diabetes Care. 2020 Nov;43(11):2713-2720. doi: 10.2337/dc20-0924. Epub 2020 Sep 14.
citation: Danne T, Joish VN, Afonso M, Banks P, Sawhney S, Lapuerta P, Davies MJ, Buse JB, Lin D, Reaney M, Guillonneau S, Snoek FJ, Bailey TS, Polonsky WH. Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone. Diabetes Technol Ther. 2021 Jan;23(1):70-77. doi: 10.1089/dia.2020.0068.
citation: Ervin C, Joish VN, Evans E, DiBenedetti D, Reaney M, Preblick R, Castro R, Danne T, Buse JB, Lapuerta P. Insights Into Patients' Experience With Type 1 Diabetes: Exit Interviews From Phase III Studies of Sotagliflozin. Clin Ther. 2019 Nov;41(11):2219-2230.e6. doi: 10.1016/j.clinthera.2019.09.003. Epub 2019 Oct 3.
citation: Danne T, Cariou B, Buse JB, Garg SK, Rosenstock J, Banks P, Kushner JA, McGuire DK, Peters AL, Sawhney S, Strumph P. Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program. Diabetes Care. 2019 May;42(5):919-930. doi: 10.2337/dc18-2149. Epub 2019 Mar 4.
citation: Buse JB, Garg SK, Rosenstock J, Bailey TS, Banks P, Bode BW, Danne T, Kushner JA, Lane WS, Lapuerta P, McGuire DK, Peters AL, Reed J, Sawhney S, Strumph P. Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study. Diabetes Care. 2018 Sep;41(9):1970-1980. doi: 10.2337/dc18-0343. Epub 2018 Jun 24.