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Type 2 Diabetes MellitusPhase 3SOTA-CKD3NCT03242252

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

A Phase 3 study testing Sotagliflozin in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease Stage 3, run by Lexicon Pharmaceuticals at 170 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sotagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
787 participants
Where
170 sitesin 16 countries
Study dates
16 Aug 2017to 25 Oct 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

170 sites in 16 countries.

170 sites in 16 countries

United States51 sites

  • Investigational Site Number 8404031

    Anderson, South Carolina, 29621

  • Investigational Site Number 8404015

    Austin, Texas, 78726-4061

  • Investigational Site Number 8404050

    Austin, Texas, 78731

  • Investigational Site Number 8404060

    Austin, Texas, 78749

  • Investigational Site Number 8404005

    Beaumont, Texas, 77702

  • Investigational Site Number 8404018

    Birmingham, Alabama, 35205

  • Investigational Site Number 8404056

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 8404023

    Chula Vista, California, 91910

  • Investigational Site Number 8404019

    Clearwater, Florida, 33761

  • Investigational Site Number 8404035

    Dallas, Texas, 75208

  • Investigational Site Number 8404026

    Dayton, Ohio, 45419-4336

  • Investigational Site Number 8404001

    DeLand, Florida, 32720-0834

  • Investigational Site Number 8404044

    Gold River, California, 95670

  • Investigational Site Number 8404045

    Guntersville, Alabama, 35976-2206

  • Investigational Site Number 8404048

    Hackensack, New Jersey, 07601-1963

  • Investigational Site Number 8404039

    Houston, Texas, 77058

  • Investigational Site Number 8404055

    Houston, Texas, 77099

  • Investigational Site Number 8404012

    Hurst, Texas, 76054

  • Investigational Site Number 8404047

    Kenosha, Wisconsin, 53144

  • Investigational Site Number 8404036

    Lake Charles, Louisiana, 70601

  • Investigational Site Number 8404033

    Lampasas, Texas, 76550-1820

  • Investigational Site Number 8404052

    Lansdale, Pennsylvania, 19446-1002

  • Investigational Site Number 8404008

    Layton, Utah, 84041-1200

  • Investigational Site Number 8404007

    Little Rock, Arkansas, 72205

  • Investigational Site Number 8404011

    Los Angeles, California, 90057

  • Investigational Site Number 8404053

    McAllen, Texas, 78504

  • Investigational Site Number 8404021

    Mt. Pleasant, South Carolina, 29464

  • Investigational Site Number 8404020

    New Orleans, Louisiana, 70119-6302

  • Investigational Site Number 8404074

    New York, New York, 00000

  • Investigational Site Number 8404003

    Norco, California, 92860

  • Investigational Site Number 8404014

    Norfolk, Nebraska, 68701

  • Investigational Site Number 8404025

    Northridge, California, 91324

  • Investigational Site Number 8404006

    Ocoee, Florida, 34761-4547

  • Investigational Site Number 8404064

    Orlando, Florida, 32806

  • Investigational Site Number 8404043

    Ormond Beach, Florida, 32174-8187

  • Investigational Site Number 8404013

    Palmetto Bay, Florida, 33157-5503

  • Investigational Site Number 8404032

    Papillion, Nebraska, 68046-3136

  • Investigational Site Number 8404004

    Phoenix, Arizona, 85018-2701

  • Investigational Site Number 8404022

    Phoenix, Arizona, 85050-7500

  • Investigational Site Number 8404042

    Renton, Washington, 98057

  • Investigational Site Number 8404057

    Round Rock, Texas, 78681

  • Investigational Site Number 8404059

    San Antonio, Texas, 78212

  • Investigational Site Number 8404010

    San Antonio, Texas, 78249-2782

  • Investigational Site Number 8404038

    San Dimas, California, 91713

  • Investigational Site Number 8404016

    Savannah, Georgia, 31406

  • Investigational Site Number 8404041

    Seattle, Washington, 98105

  • Investigational Site Number 8404009

    The Bronx, New York, 10455

  • Investigational Site Number 8404040

    Wauconda, Illinois, 60084-2452

  • Investigational Site Number 8404051

    Wilmington, North Carolina, 28401-6638

  • Investigational Site Number 8404028

    Winston-Salem, North Carolina, 27103-3914

  • Investigational Site Number 8404029

    Winston-Salem, North Carolina, 27103-4027

Other trials in United States

Israel12 sites

  • Investigational Site Number 3764001

    Ashkelon, 7830604

  • Investigational Site Number 3764010

    Beersheba, 84101

  • Investigational Site Number 3764007

    Haifa, 31096

  • Investigational Site Number 3764009

    Kfar Saba, 44281

  • Investigational Site Number 3764011

    Kfar Saba, 44281

  • Investigational Site Number 3764003

    Nahariya, 22100

  • Investigational Site Number 3764004

    Petah Tikva, 49100

  • Investigational Site Number 3764006

    Ramat Gan, 52621

  • Investigational Site Number 3764005

    Rehovot, 76100

  • Investigational Site Number 3764008

    Safed, 13100

  • Investigational Site Number 3764002

    Tel Aviv, 61480

  • Investigational Site Number 3764013

    Tsrifin, 70300

Other trials in Israel

Poland11 sites

  • Investigational Site Number 6164002

    Bialystok, 15-435

  • Investigational Site Number 6164006

    Katowice, 40-081

  • Investigational Site Number 6164010

    Krakow, 30-033

  • Investigational Site Number 6164009

    Krakow, 30-363

  • Investigational Site Number 6164004

    Krakow, 31-209

  • Investigational Site Number 6164008

    Krakow, 31-530

  • Investigational Site Number 6164011

    Lodz, 92-213

  • Investigational Site Number 6164005

    Oświęcim, 32-600

  • Investigational Site Number 6164003

    Rzeszów, 35-055

  • Investigational Site Number 6164012

    Skierniewice, 96-100

  • Investigational Site Number 6164007

    Warsaw, 02-507

Other trials in Poland

Canada10 sites

  • Investigational Site Number 1244007

    Brampton, L6S 0C6

  • Investigational Site Number 1244004

    Burlington, L7R 1A4

  • Investigational Site Number 1244005

    Etobicoke, M9R 4E1

  • Investigational Site Number 1244006

    Laval, H7T 2P5

  • Investigational Site Number 1244009

    Montreal, H4A 2C6

  • Investigational Site Number 1244010

    Ottawa, K2J 0V2

  • Investigational Site Number 1244003

    Thornhill, L4J 8L7

  • Investigational Site Number 1244002

    Toronto, M4C 5T2

  • Investigational Site Number 1244008

    Toronto, M4G 3E8

  • Investigational Site Number 1244001

    Vancouver, V5Y 3W2

Other trials in Canada

Hungary10 sites

  • Investigational Site Number 3484008

    Baja, 6500

  • Investigational Site Number 3484012

    Baja, 6500

  • Investigational Site Number 3484002

    Balatonfüred, 8230

  • Investigational Site Number 3484007

    Budapest, 1033

  • Investigational Site Number 3484011

    Debrecen, 4025

  • Investigational Site Number 3484005

    Debrecen, 4032

  • Investigational Site Number 3484001

    Gyula, 5700

  • Investigational Site Number 3484010

    Nyíregyháza, 4405

  • Investigational Site Number 3484013

    Nyregyhza, 4400

  • Investigational Site Number 3484004

    Pécs, 7623

Other trials in Hungary

Ukraine10 sites

  • Investigational Site Number 8044004

    Dnipropetrovsk, 49005

  • Investigational Site Number 8044007

    Kharkiv, 61106

  • Investigational Site Number 8044010

    Kharkiv, 61166

  • Investigational Site Number 8044008

    Kiev, 02002

  • Investigational Site Number 8044003

    Kiev, 04050

  • Investigational Site Number 8044009

    Kyiv, 02091

  • Investigational Site Number 8044001

    Kyiv, 03037

  • Investigational Site Number 8044006

    Kyiv, 03049

  • Investigational Site Number 8044005

    Lviv, 79010

  • Investigational Site Number 8044002

    Zaporizhia, 69600

Other trials in Ukraine

Colombia8 sites

  • Investigational Site Number 1704008

    Barranquilla, 080001

  • Investigational Site Number 1704007

    Barranquilla, 80020

  • Investigational Site Number 1704004

    Bogotá, 110221

  • Investigational Site Number 1704009

    Bogotá, 110911

  • Investigational Site Number 1704006

    Ibague, 730006

  • Investigational Site Number 1704001

    Manizales, 170004

  • Investigational Site Number 1704002

    Medellin / Antioquia, 50021

  • Investigational Site Number 1704005

    Zipaquirá, 250252

Other trials in Colombia

Romania8 sites

  • Investigational Site Number 6424002

    Bacau, 600154

  • Investigational Site Number 6424001

    Bacau, 600238

  • Investigational Site Number 6424004

    Bucharest, 010825

  • Investigational Site Number 6424009

    Bucharest, 013764

  • Investigational Site Number 6424010

    Bucharest, 040172

  • Investigational Site Number 6424006

    Hunedoara, 331057

  • Investigational Site Number 6424011

    Oradea, 410159

  • Investigational Site Number 6424003

    Târgu Mureş, 540142

Other trials in Romania

Argentina7 sites

  • Investigational Site Number 0324001

    Buenos Aires, C1429BWN

  • Investigational Site Number 0324002

    Caba, 1425DES

  • Investigational Site Number 0324005

    Ciudad Autónoma Buenos Aires, 1205

  • Investigational Site Number 0324008

    Córdoba, 5000

  • Investigational Site Number 0324006

    Córdoba, X5008HHW

  • Investigational Site Number 0324009

    La Plata, 1900

  • Investigational Site Number 0324007

    Mar del Plata, B7600FYK

Other trials in Argentina

Brazil7 sites

  • Investigational Site Number 0764001

    Belém, 66073-005

  • Investigational Site Number 0764007

    Belo Horizonte, 30150-240

  • Investigational Site Number 0764002

    Curitiba, 80030-480

  • Investigational Site Number 0764008

    Curitiba, 80810-040

  • Investigational Site Number 0764005

    Rio de Janeiro, 22271-100

  • Investigational Site Number 0764004

    São Paulo, 01244-030

  • Investigational Site Number 0764006

    São Paulo, 04266-010

Other trials in Brazil

Italy7 sites

  • Investigational Site Number 3804007

    Catania, 95123

  • Investigational Site Number 3804005

    Milan, 20122

  • Investigational Site Number 3804004

    Milan, 20132

  • Investigational Site Number 3804008

    Naples, 80131

  • Investigational Site Number 3804002

    Naples, 80138

  • Investigational Site Number 3804003

    Roma, 00168

  • Investigational Site Number 3804006

    Siena, 53100

Other trials in Italy

Mexico7 sites

  • Investigational Site Number 4844009

    Chihuahua Chihuahua, 31217

  • Investigational Site Number 4844008

    Durango, Durango, 34080

  • Investigational Site Number 4844001

    Guadalajara, 44210

  • Investigational Site Number 4844003

    Guadalajara, 44600

  • Investigational Site Number 4844006

    Merida, Yucatan, 97130

  • Investigational Site Number 4844005

    Monterrey, 64460

  • Investigational Site Number 4844004

    Xalapa, 91020

Other trials in Mexico

Spain7 sites

  • Investigational Site Number 7244011

    Barcelona, 08035

  • Investigational Site Number 7244007

    Granada, 18012

  • Investigational Site Number 7244003

    Madrid, 28041

  • Investigational Site Number 7244006

    Palma de Mallorca, 07010

  • Investigational Site Number 7244001

    Seville, 41071

  • Investigational Site Number 7244002

    Valencia, 46014

  • Investigational Site Number 7244009

    Zaragoza, 50009

Other trials in Spain

Russia6 sites

  • Investigational Site Number 6434003

    Chelyabinsk, 454047

  • Investigational Site Number 6434005

    Kemerovo, 650002

  • Investigational Site Number 6434002

    Krasnodar, 3500

  • Investigational Site Number 6434004

    Novosibirsk, 630091

  • Investigational Site Number 6434001

    Saint Petersburg, 194358

  • Investigational Site Number 6434006

    Yaroslavl, 150003

Other trials in Russia

South Africa6 sites

  • Investigational Site Number 7104008

    Cape Town, 7531

  • Investigational Site Number 7104002

    Cape Town, 7570

  • Investigational Site Number 7104001

    Johannesburg, 1685

  • Investigational Site Number 7104010

    Johannesburg, 2188

  • Investigational Site Number 7104005

    Johannesburg, 2198

  • Investigational Site Number 7104006

    Pretoria, 0002

Other trials in South Africa

Germany3 sites

  • Investigational Site Number 2764001

    Frankfurt am Main, 60596

  • Investigational Site Number 2764002

    Hamburg, 21073

  • Investigational Site Number 2764003

    Münster, 48145

Other trials in Germany

About this study

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

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.
Read the 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.

Being tested
Placebo, Sotagliflozin
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily.

    Route of administration: Oral

  • SotagliflozinDrug

    Also called SAR439954

    Sotagliflozin 200 mg, tablet, orally once daily.

    Route of administration: Oral

Study groups in NCT03242252
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFollowing 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.
Receives: Drug: Placebo
Sotagliflozin 200 mgExperimentalFollowing 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.
Receives: Drug: Placebo; Drug: Sotagliflozin
Sotagliflozin 400 mgExperimentalFollowing 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.
Receives: Drug: Sotagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in HbA1c at Week 26

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

    Measured: Baseline to Week 26

Secondary outcomes (8)

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

    An ANCOVA model was used for analysis.

    Measured: Baseline to Week 26

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

    An ANCOVA model was used for analysis.

    Measured: Baseline to Week 12

  3. Change From Baseline in SBP at Week 12 for All Participants

    An ANCOVA model was used for analysis.

    Measured: Baseline to Week 12

  4. Change From Baseline in Body Weight at Week 26

    An ANCOVA model was used for analysis.

    Measured: Baseline to Week 26

  5. 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.

    Measured: Baseline to Week 26

  6. Percentage of Participants With HbA1c <6.5% at Week 26

    Measured: Week 26

  7. Percentage of Participants With HbA1c <7.0% at Week 26

    Measured: Week 26

  8. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2017
  2. Study start16 Aug 2017
  3. Primary completion25 Mar 2019
  4. Study completion25 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
787 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03242252
Sponsor's protocol ID
EFC14837
Other IDs
2016-004889-26, U1111-1187-8662, 2016
Acronym
SOTA-CKD3
Status last verified
May 2021
First submitted
3 Aug 2017
Last updated
25 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36782093

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease Stage 3, run by Lexicon Pharmaceuticals at 170 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, Israel, Poland, Canada, Hungary and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c at Week 26 (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03242252, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.

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