Clinical trial NCT03242252: Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Official title: A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Disease Stage 3
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2017-08-08
Enrollment: 787
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: Primary Objective:

To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment.

Secondary Objectives:

* To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight.
* To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.

Detailed description: The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment, and a visit 4 weeks after completion of the randomized treatment period.

Eligibility criteria: Inclusion criteria :

* Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30 and \<60 milliliter per minute (mL/min)/1.73 meter square (m\^2) (chronic kidney disease \[CKD\] 3A, 3B).
* Participants has given written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

* Hemoglobin A1c (HbA1c) of \<7.0% or \>11.0%.
* Type 1 diabetes.
* Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
* Treatment with a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin, Dapagliflozin, Empagliflozin) during the last 12 months.
* Uncontrolled high blood pressure.
* Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
* Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 26
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: Baseline to Week 26
measure: Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in SBP at Week 12 for All Participants
timeFrame: Baseline to Week 12
measure: Change From Baseline in Body Weight at Week 26
timeFrame: Baseline to Week 26
measure: Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)
timeFrame: Baseline to Week 26
measure: Percentage of Participants With HbA1c <6.5% at Week 26
timeFrame: Week 26
measure: Percentage of Participants With HbA1c <7.0% at Week 26
timeFrame: Week 26
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 60 weeks
Other outcomes:
measure: Percentage of Participants With Hypoglycemic Events
timeFrame: Up to 60 weeks
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 8404018
state: Alabama
city: Guntersville
country: United States
facility: Investigational Site Number 8404045
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site Number 8404004
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 8404022
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number 8404007
state: Arkansas
city: Chula Vista
country: United States
facility: Investigational Site Number 8404023
state: California
city: Gold River
country: United States
facility: Investigational Site Number 8404044
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 8404011
state: California
city: Norco
country: United States
facility: Investigational Site Number 8404003
state: California
city: Northridge
country: United States
facility: Investigational Site Number 8404025
state: California
city: San Dimas
country: United States
facility: Investigational Site Number 8404038
state: California
city: Clearwater
country: United States
facility: Investigational Site Number 8404019
state: Florida
city: DeLand
country: United States
facility: Investigational Site Number 8404001
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 8404006
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 8404064
state: Florida
city: Ormond Beach
country: United States
facility: Investigational Site Number 8404043
state: Florida
city: Palmetto Bay
country: United States
facility: Investigational Site Number 8404013
state: Florida
city: Savannah
country: United States
facility: Investigational Site Number 8404016
state: Georgia
city: Wauconda
country: United States
facility: Investigational Site Number 8404040
state: Illinois
city: Lake Charles
country: United States
facility: Investigational Site Number 8404036
state: Louisiana
city: New Orleans
country: United States
facility: Investigational Site Number 8404020
state: Louisiana
city: Norfolk
country: United States
facility: Investigational Site Number 8404014
state: Nebraska
city: Papillion
country: United States
facility: Investigational Site Number 8404032
state: Nebraska
city: Hackensack
country: United States
facility: Investigational Site Number 8404048
state: New Jersey
city: Bronx
country: United States
facility: Investigational Site Number 8404009
state: New York
city: New York
country: United States
facility: Investigational Site Number 8404074
state: New York
city: Wilmington
country: United States
facility: Investigational Site Number 8404051
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site Number 8404028
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site Number 8404029
state: North Carolina
city: Dayton
country: United States
facility: Investigational Site Number 8404026
state: Ohio
city: Lansdale
country: United States
facility: Investigational Site Number 8404052
state: Pennsylvania
city: Anderson
country: United States
facility: Investigational Site Number 8404031
state: South Carolina
city: Mount Pleasant
country: United States
facility: Investigational Site Number 8404021
state: South Carolina
city: Chattanooga
country: United States
facility: Investigational Site Number 8404056
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 8404015
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 8404050
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 8404060
state: Texas
city: Beaumont
country: United States
facility: Investigational Site Number 8404005
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 8404035
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 8404039
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 8404055
state: Texas
city: Hurst
country: United States
facility: Investigational Site Number 8404012
state: Texas
city: Lampasas
country: United States
facility: Investigational Site Number 8404033
state: Texas
city: McAllen
country: United States
facility: Investigational Site Number 8404053
state: Texas
city: Round Rock
country: United States
facility: Investigational Site Number 8404057
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8404059
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 8404010
state: Texas
city: Layton
country: United States
facility: Investigational Site Number 8404008
state: Utah
city: Renton
country: United States
facility: Investigational Site Number 8404042
state: Washington
city: Seattle
country: United States
facility: Investigational Site Number 8404041
state: Washington
city: Kenosha
country: United States
facility: Investigational Site Number 8404047
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 0324001
city: Caba
country: Argentina
facility: Investigational Site Number 0324002
city: Ciudad Autónoma Buenos Aires
country: Argentina
facility: Investigational Site Number 0324005
city: Cordoba
country: Argentina
facility: Investigational Site Number 0324008
city: Córdoba
country: Argentina
facility: Investigational Site Number 0324006
city: La Plata
country: Argentina
facility: Investigational Site Number 0324009
city: Mar Del Plata
country: Argentina
facility: Investigational Site Number 0324007
city: Belo Horizonte
country: Brazil
facility: Investigational Site Number 0764007
city: Belém
country: Brazil
facility: Investigational Site Number 0764001
city: Curitiba
country: Brazil
facility: Investigational Site Number 0764002
city: Curitiba
country: Brazil
facility: Investigational Site Number 0764008
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 0764005
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 0764006
city: São Paulo
country: Brazil
facility: Investigational Site Number 0764004
city: Brampton
country: Canada
facility: Investigational Site Number 1244007
city: Burlington
country: Canada
facility: Investigational Site Number 1244004
city: Etobicoke
country: Canada
facility: Investigational Site Number 1244005
city: Laval
country: Canada
facility: Investigational Site Number 1244006
city: Montreal
country: Canada
facility: Investigational Site Number 1244009
city: Ottawa
country: Canada
facility: Investigational Site Number 1244010
city: Thornhill
country: Canada
facility: Investigational Site Number 1244003
city: Toronto
country: Canada
facility: Investigational Site Number 1244002
city: Toronto
country: Canada
facility: Investigational Site Number 1244008
city: Vancouver
country: Canada
facility: Investigational Site Number 1244001
city: Barranquilla
country: Colombia
facility: Investigational Site Number 1704008
city: Barranquilla
country: Colombia
facility: Investigational Site Number 1704007
city: Bogota
country: Colombia
facility: Investigational Site Number 1704004
city: Bogota
country: Colombia
facility: Investigational Site Number 1704009
city: Ibague
country: Colombia
facility: Investigational Site Number 1704006
city: Manizales
country: Colombia
facility: Investigational Site Number 1704001
city: Medellin / Antioquia
country: Colombia
facility: Investigational Site Number 1704002
city: Zipaquira
country: Colombia
facility: Investigational Site Number 1704005
city: Frankfurt Am Main
country: Germany
facility: Investigational Site Number 2764001
city: Hamburg
country: Germany
facility: Investigational Site Number 2764002
city: Münster
country: Germany
facility: Investigational Site Number 2764003
city: Baja
country: Hungary
facility: Investigational Site Number 3484008
city: Baja
country: Hungary
facility: Investigational Site Number 3484012
city: Balatonfured
country: Hungary
facility: Investigational Site Number 3484002
city: Budapest
country: Hungary
facility: Investigational Site Number 3484007
city: Debrecen
country: Hungary
facility: Investigational Site Number 3484011
city: Debrecen
country: Hungary
facility: Investigational Site Number 3484005
city: Gyula
country: Hungary
facility: Investigational Site Number 3484001
city: Nyiregyhaza
country: Hungary
facility: Investigational Site Number 3484010
city: Nyregyhza
country: Hungary
facility: Investigational Site Number 3484013
city: Pécs
country: Hungary
facility: Investigational Site Number 3484004
city: Ashkelon
country: Israel
facility: Investigational Site Number 3764001
city: Be'Er-Sheva
country: Israel
facility: Investigational Site Number 3764010
city: Haifa
country: Israel
facility: Investigational Site Number 3764007
city: Kfar-Saba
country: Israel
facility: Investigational Site Number 3764009
city: Kfar-Saba
country: Israel
facility: Investigational Site Number 3764011
city: Nahariya
country: Israel
facility: Investigational Site Number 3764003
city: Petach Tikva
country: Israel
facility: Investigational Site Number 3764004
city: Ramat Gan
country: Israel
facility: Investigational Site Number 3764006
city: Rehovot
country: Israel
facility: Investigational Site Number 3764005
city: Tel Aviv
country: Israel
facility: Investigational Site Number 3764002
city: Zefat
country: Israel
facility: Investigational Site Number 3764008
city: Zerifin
country: Israel
facility: Investigational Site Number 3764013
city: Catania
country: Italy
facility: Investigational Site Number 3804007
city: Milano
country: Italy
facility: Investigational Site Number 3804005
city: Milano
country: Italy
facility: Investigational Site Number 3804004
city: Naples
country: Italy
facility: Investigational Site Number 3804008
city: Napoli
country: Italy
facility: Investigational Site Number 3804002
city: Roma
country: Italy
facility: Investigational Site Number 3804003
city: Siena
country: Italy
facility: Investigational Site Number 3804006
city: Chihuahua Chihuahua
country: Mexico
facility: Investigational Site Number 4844009
city: Durango, Durango
country: Mexico
facility: Investigational Site Number 4844008
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4844001
city: Guadalajara
country: Mexico
facility: Investigational Site Number 4844003
city: Merida, Yucatan
country: Mexico
facility: Investigational Site Number 4844006
city: Monterrey
country: Mexico
facility: Investigational Site Number 4844005
city: Xalapa
country: Mexico
facility: Investigational Site Number 4844004
city: Białystok
country: Poland
facility: Investigational Site Number 6164002
city: Katowice
country: Poland
facility: Investigational Site Number 6164006
city: Krakow
country: Poland
facility: Investigational Site Number 6164010
city: Krakow
country: Poland
facility: Investigational Site Number 6164009
city: Krakow
country: Poland
facility: Investigational Site Number 6164004
city: Krakow
country: Poland
facility: Investigational Site Number 6164008
city: Lodz
country: Poland
facility: Investigational Site Number 6164011
city: Oswiecim
country: Poland
facility: Investigational Site Number 6164005
city: Rzeszow
country: Poland
facility: Investigational Site Number 6164003
city: Skierniewice
country: Poland
facility: Investigational Site Number 6164012
city: Warszawa
country: Poland
facility: Investigational Site Number 6164007
city: Bacau
country: Romania
facility: Investigational Site Number 6424002
city: Bacau
country: Romania
facility: Investigational Site Number 6424001
city: Bucuresti
country: Romania
facility: Investigational Site Number 6424004
city: Bucuresti
country: Romania
facility: Investigational Site Number 6424009
city: Bucuresti
country: Romania
facility: Investigational Site Number 6424010
city: Hunedoara
country: Romania
facility: Investigational Site Number 6424006
city: Oradea
country: Romania
facility: Investigational Site Number 6424011
city: Targu-Mures
country: Romania
facility: Investigational Site Number 6424003
city: Chelyabinsk
country: Russian Federation
facility: Investigational Site Number 6434003
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 6434005
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 6434002
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 6434004
city: St. Petersburg
country: Russian Federation
facility: Investigational Site Number 6434001
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 6434006
city: Cape Town
country: South Africa
facility: Investigational Site Number 7104008
city: Cape Town
country: South Africa
facility: Investigational Site Number 7104002
city: Johannesburg
country: South Africa
facility: Investigational Site Number 7104001
city: Johannesburg
country: South Africa
facility: Investigational Site Number 7104010
city: Johannesburg
country: South Africa
facility: Investigational Site Number 7104005
city: Pretoria
country: South Africa
facility: Investigational Site Number 7104006
city: Barcelona
country: Spain
facility: Investigational Site Number 7244011
city: Granada
country: Spain
facility: Investigational Site Number 7244007
city: Madrid
country: Spain
facility: Investigational Site Number 7244003
city: Palma De Mallorca
country: Spain
facility: Investigational Site Number 7244006
city: Sevilla
country: Spain
facility: Investigational Site Number 7244001
city: Valencia
country: Spain
facility: Investigational Site Number 7244002
city: Zaragoza
country: Spain
facility: Investigational Site Number 7244009
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site Number 8044004
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8044007
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 8044010
city: Kiev
country: Ukraine
facility: Investigational Site Number 8044008
city: Kiev
country: Ukraine
facility: Investigational Site Number 8044003
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8044009
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8044001
city: Kyiv
country: Ukraine
facility: Investigational Site Number 8044006
city: Lviv
country: Ukraine
facility: Investigational Site Number 8044005
city: Zaporizhia
country: Ukraine
facility: Investigational Site Number 8044002
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason, MD
role: STUDY_DIRECTOR
References: