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NCT03242252 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

— SOTA-CKD3  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03242252
Other study ID # EFC14837
Secondary ID 2016-004889-26U1
Status Completed
Phase Phase 3
First received
Last updated
Start date August 16, 2017
Est. completion date October 25, 2019

Study information
Verified date May 2021
Source Lexicon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 787
Est. completion date October 25, 2019
Est. primary completion date March 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily. Route of administration: Oral
• Sotagliflozin
Sotagliflozin 200 mg, tablet, orally once daily. Route of administration: Oral

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

Sponsors (2)
Lead Sponsor Collaborator
Lexicon Pharmaceuticals Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Colombia,  Germany,  Hungary,  Israel,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Other Percentage of Participants With Hypoglycemic Events Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose = 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose = 70 mg/dL]. Up to 60 weeks
Primary Change From Baseline in HbA1c at Week 26 An Analysis of covariance (ANCOVA) model was used for analysis. Baseline to Week 26
Secondary Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 An ANCOVA model was used for analysis. Baseline to Week 26
Secondary Change From Baseline in SBP for Participants With Baseline SBP =130 mmHg at Week 12 An ANCOVA model was used for analysis. Baseline to Week 12
Secondary Change From Baseline in SBP at Week 12 for All Participants An ANCOVA model was used for analysis. Baseline to Week 12
Secondary Change From Baseline in Body Weight at Week 26 An ANCOVA model was used for analysis. Baseline to Week 26
Secondary 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) An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated. Baseline to Week 26
Secondary Percentage of Participants With HbA1c <6.5% at Week 26 Week 26
Secondary Percentage of Participants With HbA1c <7.0% at Week 26 Week 26
Secondary Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Up to 60 weeks
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