Clinical trial NCT02421510: 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
Keywords: High level of sugar (glucose) in the blood
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2015-04-20
Enrollment: 782
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:

* Participant who gave 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 treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol.
* At the Screening Visit, A1C was 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.

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) From Baseline to Week 24
timeFrame: Baseline to Week 24
measure: 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 Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24
timeFrame: Baseline to Week 24
measure: Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score 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: Linz
country: Austria
facility: Lexicon Investigational Site
city: Vienna
country: Austria
facility: Lexicon Investigational Site
city: Vienna
country: Austria
facility: Lexicon Investigational Site
city: Vienna
country: Austria
facility: Lexicon Investigational Site
city: Vienna
country: Austria
facility: Lexicon Investigational Site
city: Antwerp
country: Belgium
facility: Lexicon Investigational Site
city: Brussels
country: Belgium
facility: Lexicon Investigational Site
city: Edegem
country: Belgium
facility: Lexicon Investigational Site
city: Leuven
country: Belgium
facility: Lexicon Investigational Site
city: Sint Niklaas
country: Belgium
facility: Lexicon Investigational Site
city: Lovech
country: Bulgaria
facility: Lexicon Investigational Site
city: Plovdiv
country: Bulgaria
facility: Lexicon Investigational Site
city: Ruse
country: Bulgaria
facility: Lexicon Investigational Site
city: Smolyan
country: Bulgaria
facility: Lexicon Investigational Site
city: Sofia
country: Bulgaria
facility: Lexicon Investigational Site
city: Varna
country: Bulgaria
facility: Lexicon Investigational Site
city: Beziers
country: France
facility: Lexicon Investigational Site
city: Dijon cedex
country: France
facility: Lexicon Investigational Site
city: Nantes
country: France
facility: Lexicon Investigational Site
city: Nantes
country: France
facility: Lexicon Investigational Site
city: Nîmes
country: France
facility: Lexicon Investigational Site
city: Duesseldorf
country: Germany
facility: Lexicon Investigational Site
city: Hamburg
country: Germany
facility: Lexicon Investigational Site
city: Hamburg
country: Germany
facility: Lexicon Investigational Site
city: Hannover
country: Germany
facility: Lexicon Investigational Site
city: Mainz
country: Germany
facility: Lexicon Investigational Site
city: Muenster
country: Germany
facility: Lexicon Investigational Site
city: Neuwied
country: Germany
facility: Lexicon Investigational Site
city: Budapest
country: Hungary
facility: Lexicon Investigational Site
city: Budapest
country: Hungary
facility: Lexicon Investigational Site
city: Budapest
country: Hungary
facility: Lexicon Investigational Site
city: Budapest
country: Hungary
facility: Lexicon Investigational Site
city: Budapest
country: Hungary
facility: Lexicon Investigational Site
city: Gyula
country: Hungary
facility: Lexicon Investigational Site
city: Hodmezovasarhely
country: Hungary
facility: Lexicon Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Lexicon Investigational Site
city: Haifa
country: Israel
facility: Lexicon Investigational Site
city: Holon
country: Israel
facility: Lexicon Investigational Site
city: Jerusalem
country: Israel
facility: Lexicon Investigational Site
city: Petah Tikva
country: Israel
facility: Lexicon Investigational Site
city: Tel Aviv
country: Israel
facility: Lexicon Investigational Site
city: Tel Hashomer
country: Israel
facility: Lexicon Investigational Site
city: Zerifin
country: Israel
facility: Lexicon Investigational Site
city: Catania
country: Italy
facility: Lexicon Investigational Site
city: Milano
country: Italy
facility: Lexicon Investigational Site
city: Palermo
country: Italy
facility: Lexicon Investigational Site
city: Perugia
country: Italy
facility: Lexicon Investigational Site
city: Pisa
country: Italy
facility: Lexicon Investigational Site
city: Roma
country: Italy
facility: Lexicon Investigational Site
city: Jonava
country: Lithuania
facility: Lexicon Investigational Site
city: Kaunas
country: Lithuania
facility: Lexicon Investigational Site
city: Kaunas
country: Lithuania
facility: Lexicon Investigational Site
city: Dordrecht
country: Netherlands
facility: Lexicon Investigational Site
city: Katowice
country: Poland
facility: Lexicon Investigational Site
city: Kraków
country: Poland
facility: Lexicon Investigational Site
city: Lodz
country: Poland
facility: Lexicon Investigational Site
city: Lublin
country: Poland
facility: Lexicon Investigational Site
city: Poznan
country: Poland
facility: Lexicon Investigational Site
city: Szczecin
country: Poland
facility: Lexicon Investigational Site
city: Warsaw
country: Poland
facility: Lexicon Investigational Site
city: Warszawa
country: Poland
facility: Lexicon Investigational Site
city: Warszawa
country: Poland
facility: Lexicon Investigational Site
city: Bacau
country: Romania
facility: Lexicon Investigational Site
city: Bucuresti
country: Romania
facility: Lexicon Investigational Site
city: Bucuresti
country: Romania
facility: Lexicon Investigational Site
city: Buzau
country: Romania
facility: Lexicon Investigational Site
city: Galati
country: Romania
facility: Lexicon Investigational Site
city: Oradea
country: Romania
facility: Lexicon Investigational Site
city: Sibiu
country: Romania
facility: Lexicon Investigational Site
city: Targu-Mures
country: Romania
facility: Lexicon Investigational Site
city: Bratislava
country: Slovakia
facility: Lexicon Investigational Site
city: Bratislava
country: Slovakia
facility: Lexicon Investigational Site
city: Kosice
country: Slovakia
facility: Lexicon Investigational Site
city: Nove Zamky
country: Slovakia
facility: Lexicon Investigational Site
city: Sturovo
country: Slovakia
facility: Lexicon Investigational Site
city: Vrutky
country: Slovakia
facility: Lexicon Investigational Site
city: Barcelona
country: Spain
facility: Lexicon Investigational Site
city: Barcelona
country: Spain
facility: Lexicon Investigational Site
city: Granada
country: Spain
facility: Lexicon Investigational Site
city: Malaga
country: Spain
facility: Lexicon Investigational Site
city: Sevilla
country: Spain
facility: Lexicon Investigational Site
city: Sevilla
country: Spain
facility: Lexicon Investigational Site
city: Sevilla
country: Spain
facility: Lexicon Investigational Site
city: Sevilla
country: Spain
facility: Lexicon Investigational Site
city: Valencia
country: Spain
facility: Lexicon Investigational Site
city: Härnösand
country: Sweden
facility: Lexicon Investigational Site
city: Kristianstad
country: Sweden
facility: Lexicon Investigational Site
city: Stockholm
country: Sweden
facility: Lexicon Investigational Site
city: St. Gallen
country: Switzerland
facility: Lexicon Investigational Site
city: Birmingham
country: United Kingdom
facility: Lexicon Investigational Site
city: Blackburn
country: United Kingdom
facility: Lexicon Investigational Site
city: Bristol
country: United Kingdom
facility: Lexicon Investigational Site
city: Glasgow
country: United Kingdom
facility: Lexicon Investigational Site
city: Leeds
country: United Kingdom
facility: Lexicon Investigational Site
city: Leicester
country: United Kingdom
facility: Lexicon Investigational Site
city: Sheffield
country: United Kingdom
facility: Lexicon Investigational Site
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: Danne T, Cariou B, Banks P, Brandle M, Brath H, Franek E, Kushner JA, Lapuerta P, McGuire DK, Peters AL, Sawhney S, Strumph P. HbA1c and Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study. Diabetes Care. 2018 Sep;41(9):1981-1990. doi: 10.2337/dc18-0342. Epub 2018 Jun 24.