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
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 3
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

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