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

NCT03242252 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: EFC148372016-004889-26U1111-1187-8662
• Study Type: interventional
• Target: 787
• Locations: 16 countries
• Sites: 170

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.

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Disease Stage 3

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 26

  An Analysis of covariance (ANCOVA) model was used for analysis.

  Baseline to Week 26

Secondary Outcomes (8)

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

  Baseline to Week 26

• Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12

  Baseline to Week 12

• Change From Baseline in SBP at Week 12 for All Participants

  Baseline to Week 12

• Change From Baseline in Body Weight at Week 26

  Baseline to Week 26

• 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)

  Baseline to Week 26

Other Outcomes (1)

• Percentage of Participants With Hypoglycemic Events

  Up to 60 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.

Drug: Placebo

Sotagliflozin 200 mg

EXPERIMENTAL

Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.

Drug: Placebo; Drug: Sotagliflozin

Sotagliflozin 400 mg

EXPERIMENTAL

Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Drug: Sotagliflozin

Interventions

Placebo DRUG

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

Placebo; Sotagliflozin 200 mg

Sotagliflozin DRUG

Sotagliflozin 200 mg, tablet, orally once daily. Route of administration: Oral

Also known as: SAR439954

Sotagliflozin 200 mg; Sotagliflozin 400 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (170)

Investigational Site Number 8404018

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 8404045

Guntersville, Alabama, 35976-2206, United States

Location

Investigational Site Number 8404004

Phoenix, Arizona, 85018-2701, United States

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Investigational Site Number 8404022

Phoenix, Arizona, 85050-7500, United States

Location

Investigational Site Number 8404007

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 8404023

Chula Vista, California, 91910, United States

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Investigational Site Number 8404044

Gold River, California, 95670, United States

Location

Investigational Site Number 8404011

Los Angeles, California, 90057, United States

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Investigational Site Number 8404003

Norco, California, 92860, United States

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Investigational Site Number 8404025

Northridge, California, 91324, United States

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Investigational Site Number 8404038

San Dimas, California, 91713, United States

Location

Investigational Site Number 8404019

Clearwater, Florida, 33761, United States

Location

Investigational Site Number 8404001

DeLand, Florida, 32720-0834, United States

Location

Investigational Site Number 8404006

Ocoee, Florida, 34761-4547, United States

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Investigational Site Number 8404064

Orlando, Florida, 32806, United States

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Investigational Site Number 8404043

Ormond Beach, Florida, 32174-8187, United States

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Investigational Site Number 8404013

Palmetto Bay, Florida, 33157-5503, United States

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Investigational Site Number 8404016

Savannah, Georgia, 31406, United States

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Investigational Site Number 8404040

Wauconda, Illinois, 60084-2452, United States

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Investigational Site Number 8404036

Lake Charles, Louisiana, 70601, United States

Location

Investigational Site Number 8404020

New Orleans, Louisiana, 70119-6302, United States

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Investigational Site Number 8404014

Norfolk, Nebraska, 68701, United States

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Investigational Site Number 8404032

Papillion, Nebraska, 68046-3136, United States

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Investigational Site Number 8404048

Hackensack, New Jersey, 07601-1963, United States

Location

Investigational Site Number 8404074

New York, New York, 00000, United States

Location

Investigational Site Number 8404009

The Bronx, New York, 10455, United States

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Investigational Site Number 8404051

Wilmington, North Carolina, 28401-6638, United States

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Investigational Site Number 8404028

Winston-Salem, North Carolina, 27103-3914, United States

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Investigational Site Number 8404029

Winston-Salem, North Carolina, 27103-4027, United States

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Investigational Site Number 8404026

Dayton, Ohio, 45419-4336, United States

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Investigational Site Number 8404052

Lansdale, Pennsylvania, 19446-1002, United States

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Investigational Site Number 8404031

Anderson, South Carolina, 29621, United States

Location

Investigational Site Number 8404021

Mt. Pleasant, South Carolina, 29464, United States

Location

Investigational Site Number 8404056

Chattanooga, Tennessee, 37404, United States

Location

Investigational Site Number 8404015

Austin, Texas, 78726-4061, United States

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Investigational Site Number 8404050

Austin, Texas, 78731, United States

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Investigational Site Number 8404060

Austin, Texas, 78749, United States

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Investigational Site Number 8404005

Beaumont, Texas, 77702, United States

Location

Investigational Site Number 8404035

Dallas, Texas, 75208, United States

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Investigational Site Number 8404039

Houston, Texas, 77058, United States

Location

Investigational Site Number 8404055

Houston, Texas, 77099, United States

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Investigational Site Number 8404012

Hurst, Texas, 76054, United States

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Investigational Site Number 8404033

Lampasas, Texas, 76550-1820, United States

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Investigational Site Number 8404053

McAllen, Texas, 78504, United States

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Investigational Site Number 8404057

Round Rock, Texas, 78681, United States

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Investigational Site Number 8404059

San Antonio, Texas, 78212, United States

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Investigational Site Number 8404010

San Antonio, Texas, 78249-2782, United States

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Investigational Site Number 8404008

Layton, Utah, 84041-1200, United States

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Investigational Site Number 8404042

Renton, Washington, 98057, United States

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Investigational Site Number 8404041

Seattle, Washington, 98105, United States

Location

Investigational Site Number 8404047

Kenosha, Wisconsin, 53144, United States

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Investigational Site Number 0324001

Buenos Aires, C1429BWN, Argentina

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Investigational Site Number 0324002

Caba, 1425DES, Argentina

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Investigational Site Number 0324005

Ciudad Autónoma Buenos Aires, 1205, Argentina

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Investigational Site Number 0324008

Córdoba, 5000, Argentina

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Investigational Site Number 0324006

Córdoba, X5008HHW, Argentina

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Investigational Site Number 0324009

La Plata, 1900, Argentina

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Investigational Site Number 0324007

Mar del Plata, B7600FYK, Argentina

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Investigational Site Number 0764001

Belém, 66073-005, Brazil

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Investigational Site Number 0764007

Belo Horizonte, 30150-240, Brazil

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Investigational Site Number 0764002

Curitiba, 80030-480, Brazil

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Investigational Site Number 0764008

Curitiba, 80810-040, Brazil

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Investigational Site Number 0764005

Rio de Janeiro, 22271-100, Brazil

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Investigational Site Number 0764004

São Paulo, 01244-030, Brazil

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Investigational Site Number 0764006

São Paulo, 04266-010, Brazil

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Investigational Site Number 1244007

Brampton, L6S 0C6, Canada

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Investigational Site Number 1244004

Burlington, L7R 1A4, Canada

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Investigational Site Number 1244005

Etobicoke, M9R 4E1, Canada

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Investigational Site Number 1244006

Laval, H7T 2P5, Canada

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Investigational Site Number 1244009

Montreal, H4A 2C6, Canada

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Investigational Site Number 1244010

Ottawa, K2J 0V2, Canada

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Investigational Site Number 1244003

Thornhill, L4J 8L7, Canada

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Investigational Site Number 1244002

Toronto, M4C 5T2, Canada

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Investigational Site Number 1244008

Toronto, M4G 3E8, Canada

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Investigational Site Number 1244001

Vancouver, V5Y 3W2, Canada

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Investigational Site Number 1704008

Barranquilla, 080001, Colombia

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Investigational Site Number 1704007

Barranquilla, 80020, Colombia

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Investigational Site Number 1704004

Bogotá, 110221, Colombia

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Investigational Site Number 1704009

Bogotá, 110911, Colombia

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Investigational Site Number 1704006

Ibagué, 730006, Colombia

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Investigational Site Number 1704001

Manizales, 170004, Colombia

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Investigational Site Number 1704002

Medellin / Antioquia, 50021, Colombia

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Investigational Site Number 1704005

Zipaquirá, 250252, Colombia

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Investigational Site Number 2764001

Frankfurt am Main, 60596, Germany

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Investigational Site Number 2764002

Hamburg, 21073, Germany

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Investigational Site Number 2764003

Münster, 48145, Germany

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Investigational Site Number 3484008

Baja, 6500, Hungary

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Investigational Site Number 3484012

Baja, 6500, Hungary

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Investigational Site Number 3484002

Balatonfüred, 8230, Hungary

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Investigational Site Number 3484007

Budapest, 1033, Hungary

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Investigational Site Number 3484011

Debrecen, 4025, Hungary

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Investigational Site Number 3484005

Debrecen, 4032, Hungary

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Investigational Site Number 3484001

Gyula, 5700, Hungary

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Investigational Site Number 3484010

Nyíregyháza, 4405, Hungary

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Investigational Site Number 3484013

Nyregyhza, 4400, Hungary

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Investigational Site Number 3484004

Pécs, 7623, Hungary

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Investigational Site Number 3764001

Ashkelon, 7830604, Israel

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Investigational Site Number 3764010

Beersheba, 84101, Israel

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Investigational Site Number 3764007

Haifa, 31096, Israel

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Investigational Site Number 3764009

Kfar Saba, 44281, Israel

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Investigational Site Number 3764011

Kfar Saba, 44281, Israel

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Investigational Site Number 3764003

Nahariya, 22100, Israel

Location

Investigational Site Number 3764004

Petah Tikva, 49100, Israel

Location

Investigational Site Number 3764006

Ramat Gan, 52621, Israel

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Investigational Site Number 3764005

Rehovot, 76100, Israel

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Investigational Site Number 3764008

Safed, 13100, Israel

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Investigational Site Number 3764002

Tel Aviv, 61480, Israel

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Investigational Site Number 3764013

Ẕerifin, 70300, Israel

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Investigational Site Number 3804007

Catania, 95123, Italy

Location

Investigational Site Number 3804005

Milan, 20122, Italy

Location

Investigational Site Number 3804004

Milan, 20132, Italy

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Investigational Site Number 3804008

Naples, 80131, Italy

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Investigational Site Number 3804002

Napoli, 80138, Italy

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Investigational Site Number 3804003

Roma, 00168, Italy

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Investigational Site Number 3804006

Siena, 53100, Italy

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Investigational Site Number 4844009

Chihuahua Chihuahua, 31217, Mexico

Location

Investigational Site Number 4844008

Durango, Durango, 34080, Mexico

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Investigational Site Number 4844001

Guadalajara, 44210, Mexico

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Investigational Site Number 4844003

Guadalajara, 44600, Mexico

Location

Investigational Site Number 4844006

Merida, Yucatan, 97130, Mexico

Location

Investigational Site Number 4844005

Monterrey, 64460, Mexico

Location

Investigational Site Number 4844004

Xalapa, 91020, Mexico

Location

Investigational Site Number 6164002

Bialystok, 15-435, Poland

Location

Investigational Site Number 6164006

Katowice, 40-081, Poland

Location

Investigational Site Number 6164010

Krakow, 30-033, Poland

Location

Investigational Site Number 6164009

Krakow, 30-363, Poland

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Investigational Site Number 6164004

Krakow, 31-209, Poland

Location

Investigational Site Number 6164008

Krakow, 31-530, Poland

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Investigational Site Number 6164011

Lodz, 92-213, Poland

Location

Investigational Site Number 6164005

Oświęcim, 32-600, Poland

Location

Investigational Site Number 6164003

Rzeszów, 35-055, Poland

Location

Investigational Site Number 6164012

Skierniewice, 96-100, Poland

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Investigational Site Number 6164007

Warsaw, 02-507, Poland

Location

Investigational Site Number 6424002

Bacau, 600154, Romania

Location

Investigational Site Number 6424001

Bacau, 600238, Romania

Location

Investigational Site Number 6424004

Bucharest, 010825, Romania

Location

Investigational Site Number 6424009

Bucharest, 013764, Romania

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Investigational Site Number 6424010

Bucharest, 040172, Romania

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Investigational Site Number 6424006

Hunedoara, 331057, Romania

Location

Investigational Site Number 6424011

Oradea, 410159, Romania

Location

Investigational Site Number 6424003

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 6434003

Chelyabinsk, 454047, Russia

Location

Investigational Site Number 6434005

Kemerovo, 650002, Russia

Location

Investigational Site Number 6434002

Krasnodar, 3500, Russia

Location

Investigational Site Number 6434004

Novosibirsk, 630091, Russia

Location

Investigational Site Number 6434001

Saint Petersburg, 194358, Russia

Location

Investigational Site Number 6434006

Yaroslavl, 150003, Russia

Location

Investigational Site Number 7104008

Cape Town, 7531, South Africa

Location

Investigational Site Number 7104002

Cape Town, 7570, South Africa

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Investigational Site Number 7104001

Johannesburg, 1685, South Africa

Location

Investigational Site Number 7104010

Johannesburg, 2188, South Africa

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Investigational Site Number 7104005

Johannesburg, 2198, South Africa

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Investigational Site Number 7104006

Pretoria, 0002, South Africa

Location

Investigational Site Number 7244011

Barcelona, 08035, Spain

Location

Investigational Site Number 7244007

Granada, 18012, Spain

Location

Investigational Site Number 7244003

Madrid, 28041, Spain

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Investigational Site Number 7244006

Palma de Mallorca, 07010, Spain

Location

Investigational Site Number 7244001

Seville, 41071, Spain

Location

Investigational Site Number 7244002

Valencia, 46014, Spain

Location

Investigational Site Number 7244009

Zaragoza, 50009, Spain

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Investigational Site Number 8044004

Dnipropetrovsk, 49005, Ukraine

Location

Investigational Site Number 8044007

Kharkiv, 61106, Ukraine

Location

Investigational Site Number 8044010

Kharkiv, 61166, Ukraine

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Investigational Site Number 8044008

Kiev, 02002, Ukraine

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Investigational Site Number 8044003

Kiev, 04050, Ukraine

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Investigational Site Number 8044009

Kyiv, 02091, Ukraine

Location

Investigational Site Number 8044001

Kyiv, 03037, Ukraine

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Investigational Site Number 8044006

Kyiv, 03049, Ukraine

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Investigational Site Number 8044005

Lviv, 79010, Ukraine

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Investigational Site Number 8044002

Zaporizhia, 69600, Ukraine

Location

Related Publications (1)

• Cherney DZI, Ferrannini E, Umpierrez GE, Peters AL, Rosenstock J, Powell DR, Davies MJ, Banks P, Agarwal R. Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease. Diabetes Obes Metab. 2023 Jun;25(6):1646-1657. doi: 10.1111/dom.15019. Epub 2023 Feb 28.

  PMID: 36782093 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Affairs
• Organization: Lexicon Pharmaceuticals, Inc.

medical-information@lexpharma.com

(510) 338-6064

Study Officials

• Suman Wason, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 8, 2017
• Study Start: August 16, 2017
• Primary Completion: March 25, 2019
• Study Completion: October 25, 2019
• Last Updated: June 25, 2021
• Results First Posted: June 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (10); CA (10); PL (11); IT (7); ME (7); RO (8); CO (8); RU (6); AR (7); BR (7); US (51); DE (3); ZA (6); ES (7); IL (12); UA (10)