Clinical trial NCT02531035: A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus (T1DM)
High Level of Sugar (Glucose) in the Blood
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2015-08-21
Enrollment: 1405
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 designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).


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 T1DM made at least 1 year prior to informed consent
* Participants were 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 was between 7.0% to 11.0%
* Females of childbearing potential used an adequate method of contraception and had 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: Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in A1C
timeFrame: Baseline to Week 24
measure: Absolute Change From Baseline in Body Weight
timeFrame: Baseline to Week 24
measure: Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)
timeFrame: Baseline to Week 16
measure: Percent Change From Baseline in Mean Daily Bolus Insulin Dose
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Concord
country: United States
facility: Lexicon Investigational Site
state: California
city: Escondido
country: United States
facility: Lexicon Investigational Site
state: California
city: La Jolla
country: United States
facility: Lexicon Investigational Site
state: California
city: San Marcos
country: United States
facility: Lexicon Investigational Site
state: California
city: Ventura
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: New Haven
country: United States
facility: Lexicon Investigational Site
state: Connecticut
city: Orlando
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: Macon
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: New Orleans
country: United States
facility: Lexicon Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: Lexicon Investigational Site
state: Maryland
city: Boston
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Lexicon Investigational Site
state: Michigan
city: Omaha
country: United States
facility: Lexicon Investigational Site
state: Nebraska
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: Bronx
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: Greenville
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Grand Forks
country: United States
facility: Lexicon Investigational Site
state: North Dakota
city: Bend
country: United States
facility: Lexicon Investigational Site
state: Oregon
city: Sioux Falls
country: United States
facility: Lexicon Investigational Site
state: South Dakota
city: Austin
country: United States
facility: Lexicon Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Shavano Park
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Lexicon Investigational Site
state: Utah
city: Seattle
country: United States
facility: Lexicon Investigational Site
state: Washington
city: Córdoba
country: Argentina
facility: Lexicon Investigational Site
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Lexicon Investigational Site
city: Buenos Aires
country: Argentina
facility: Lexicon Investigational Site
city: Coffs Harbour
country: Australia
facility: Lexicon Investigational Site
state: New South Wales
city: Merewether
country: Australia
facility: Lexicon Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Lexicon Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: Lexicon Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Lexicon Investigational Site
state: Queensland
city: Keswick
country: Australia
facility: Lexicon Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: Lexicon Investigational Site
state: Victoria
city: Fitzroy
country: Australia
facility: Lexicon Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Lexicon Investigational Site
state: Victoria
city: Aalst
country: Belgium
facility: Lexicon Investigational Site
city: Gent
country: Belgium
facility: Lexicon Investigational Site
city: Sint-Niklaas
country: Belgium
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: Sofia
country: Bulgaria
facility: Lexicon Investigational Site
city: Varna
country: Bulgaria
facility: Lexicon Investigational Site
city: Vancouver
country: Canada
facility: Lexicon Investigational Site
state: British Columbia
city: Halifax
country: Canada
facility: Lexicon Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Lexicon Investigational Site
state: Ontario
city: London
country: Canada
facility: Lexicon Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Lexicon Investigational Site
state: Ontario
city: Oakville
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: Sherbrooke
country: Canada
facility: Lexicon Investigational Site
state: Quebec
city: St. Laurent
country: Canada
facility: Lexicon Investigational Site
state: Quebec
city: Atlantico
country: Colombia
facility: Lexicon Investigational Site
city: Cundinamarca
country: Colombia
facility: Lexicon Investigational Site
city: Cundinamarca
country: Colombia
facility: Lexicon Investigational Site
city: Cundinamarca
country: Colombia
facility: Lexicon Investigational Site
city: Krnov
country: Czechia
facility: Lexicon Investigational Site
city: Olomouc
country: Czechia
facility: Lexicon Investigational Site
city: Ostrava
country: Czechia
facility: Lexicon Investigational Site
city: Praha 10
country: Czechia
facility: Lexicon Investigational Site
city: Praha 4
country: Czechia
facility: Lexicon Investigational Site
city: Praha 5
country: Czechia
facility: Lexicon Investigational Site
city: Corbeil-Essonnes
country: France
facility: Lexicon Investigational Site
city: Pierre-Bénite
country: France
facility: Lexicon Investigational Site
city: Mainz
country: Germany
facility: Lexicon Investigational Site
state: Palatinate
city: Sulzbach
country: Germany
facility: Lexicon Investigational Site
state: Rosenberg Bavaria
city: Münster
country: Germany
facility: Lexicon Investigational Site
state: Westphalia
city: Aschaffenburg
country: Germany
facility: Lexicon Investigational Site
city: Asslar
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: Eger
country: Hungary
facility: Lexicon Investigational Site
city: Esztergom
country: Hungary
facility: Lexicon Investigational Site
city: Gyor
country: Hungary
facility: Lexicon Investigational Site
city: Sátoraljaújhely
country: Hungary
facility: Lexicon Investigational Site
city: Holon
country: Israel
facility: Lexicon Investigational Site
city: Petach-Tikvah
country: Israel
facility: Lexicon Investigational Site
city: Petah Tikva
country: Israel
facility: Lexicon Investigational Site
city: Rehovot
country: Israel
facility: Lexicon Investigational Site
city: Tel Hashomer
country: Israel
facility: Lexicon Investigational Site
city: Bologna
country: Italy
facility: Lexicon Investigational Site
city: Catania
country: Italy
facility: Lexicon Investigational Site
city: Catania
country: Italy
facility: Lexicon Investigational Site
city: Latina
country: Italy
facility: Lexicon Investigational Site
city: Milan
country: Italy
facility: Lexicon Investigational Site
city: Rome
country: Italy
facility: Lexicon Investigational Site
city: Epsom
country: New Zealand
facility: Lexicon Investigational Site
state: Auckland
city: Takapuna
country: New Zealand
facility: Lexicon Investigational Site
state: Auckland
city: Christchurch
country: New Zealand
facility: Lexicon Investigational Site
state: Canterbury
city: Dunedin
country: New Zealand
facility: Lexicon Investigational Site
state: Otago
city: Newtown
country: New Zealand
facility: Lexicon Investigational Site
state: Wellington
city: Christchurch
country: New Zealand
facility: Lexicon Investigational Site
city: Otahuhu
country: New Zealand
facility: Lexicon Investigational Site
city: Gdynia
country: Poland
facility: Lexicon Investigational Site
city: Katowice
country: Poland
facility: Lexicon Investigational Site
city: Katowice
country: Poland
facility: Lexicon Investigational Site
city: Lublin
country: Poland
facility: Lexicon Investigational Site
city: Warsaw
country: Poland
facility: Lexicon Investigational Site
city: Warsaw
country: Poland
facility: Lexicon Investigational Site
city: Warszawa
country: Poland
facility: Lexicon Investigational Site
city: Bardejov
country: Slovakia
facility: Lexicon Investigational Site
city: Bratislava
country: Slovakia
facility: Lexicon Investigational Site
city: Bratislava
country: Slovakia
facility: Lexicon Investigational Site
city: Levice
country: Slovakia
facility: Lexicon Investigational Site
city: Goodwood
country: South Africa
facility: Lexicon Investigational Site
state: Cape Town
city: Middelburg
country: South Africa
facility: Lexicon Investigational Site
state: Mpumalanga
city: Bloemfontein
country: South Africa
facility: Lexicon Investigational Site
city: Cape Town
country: South Africa
facility: Lexicon Investigational Site
city: Cape Town
country: South Africa
facility: Lexicon Investigational Site
city: Johannesburg
country: South Africa
facility: Lexicon Investigational Site
city: Port Elizabeth
country: South Africa
facility: Lexicon Investigational Site
city: Barcelona
country: Spain
facility: Lexicon Investigational Site
city: Barcelona
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: Dundee
country: United Kingdom
facility: Lexicon Investigational Site
state: Scotland
city: Blackburn
country: United Kingdom
facility: Lexicon Investigational Site
city: Guildford
country: United Kingdom
facility: Lexicon Investigational Site
city: Leicester
country: United Kingdom
facility: Lexicon Investigational Site
city: Northampton
country: United Kingdom
facility: Lexicon Investigational Site
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Sangeeta Sawhney, MD
role: STUDY_DIRECTOR
References:
citation: Garg SK, Henry RR, Banks P, Buse JB, Davies MJ, Fulcher GR, Pozzilli P, Gesty-Palmer D, Lapuerta P, Simo R, Danne T, McGuire DK, Kushner JA, Peters A, Strumph P. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med. 2017 Dec 14;377(24):2337-2348. doi: 10.1056/NEJMoa1708337. Epub 2017 Sep 13.