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Type 2 Diabetes MellitusPhase 3SOTA-CKD4NCT03242018

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe 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 4, run by Lexicon Pharmaceuticals at 106 sites in 15 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 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: To assess the effects of… 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
277 participants
Where
106 sitesin 15 countries
Study dates
16 Aug 2017to 11 Dec 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 severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD) equation) of ≥15 and <30 milliliter per minute (mL/min)/1.73 per meter square (m^2).
  • Signed written informed consent to participate in the study in accordance with local regulations.

Who cannot join

  • At the time of screening, age <18 years.
  • Hemoglobin A1c (HbA1c) <7% or >11%.
  • 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 an sodium-glucose cotransporter type 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
  • Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy, 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

106 sites in 15 countries.

106 sites in 15 countries

United States34 sites

  • Investigational Site Number 8405035

    Albany, New York, 12206

  • Investigational Site Number 8405041

    Arlington Heights, Illinois, 60005-4197

  • Investigational Site Number 8405004

    Beaumont, Texas, 77702

  • Investigational Site Number 8405015

    Chula Vista, California, 91910

  • Investigational Site Number 8405021

    Clearwater, Florida, 33761-2022

  • Investigational Site Number 8405036

    Dallas, Texas, 75208

  • Investigational Site Number 8405009

    Dayton, Ohio, 45419-4336

  • Investigational Site Number 8405001

    DeLand, Florida, 32720-0834

  • Investigational Site Number 8405034

    Flint, Michigan, 48532-3447

  • Investigational Site Number 8405033

    Guntersville, Alabama, 35976-2206

  • Investigational Site Number 8405020

    Houston, Texas, 77058

  • Investigational Site Number 8405026

    Houston, Texas, 77099-4307

  • Investigational Site Number 8405047

    Hurst, Texas, 76054

  • Investigational Site Number 8405032

    La Jolla, California, 92037

  • Investigational Site Number 8405019

    Lake Charles, Louisiana, 70601

  • Investigational Site Number 8405027

    Laurelton, New York, 11413

  • Investigational Site Number 8405039

    Lawrenceville, Georgia, 30046

  • Investigational Site Number 8405008

    Layton, Utah, 84041-1200

  • Investigational Site Number 8405007

    Little Rock, Arkansas, 72205

  • Investigational Site Number 8405043

    Miami, Florida, 33155-4630

  • Investigational Site Number 8405037

    New Bern, North Carolina, 28562-5200

  • Investigational Site Number 8405003

    Norco, California, 92860-3611

  • Investigational Site Number 8405012

    Norfolk, Nebraska, 68701-2669

  • Investigational Site Number 8405013

    Northridge, California, 91324

  • Investigational Site Number 8405006

    Ocoee, Florida, 34761-4547

  • Investigational Site Number 8405025

    Ormond Beach, Florida, 32174-8187

  • Investigational Site Number 8405005

    Phoenix, Arizona, 85018-2701

  • Investigational Site Number 8405031

    San Antonio, Texas, 78215

  • Investigational Site Number 8405016

    San Antonio, Texas, 78249-2782

  • Investigational Site Number 8405018

    San Dimas, California, 91773

  • Investigational Site Number 8405030

    Sellersburg, Indiana, 47172-8932

  • Investigational Site Number 8405014

    The Bronx, New York, 10455

  • Investigational Site Number 8405040

    Winchester, Virginia, 22601

  • Investigational Site Number 8405038

    Winston-Salem, North Carolina, 27103

Other trials in United States

Mexico8 sites

  • Investigational Site Number 4845001

    Guadalajara, 44210

  • Investigational Site Number 4845004

    Guadalajara, 44600

  • Investigational Site Number 4845007

    Guadalajara Jalisco, 44130

  • Investigational Site Number 4845008

    Merida, Yucatan, 97130

  • Investigational Site Number 4845006

    Monterrey, N.L, 64460

  • Investigational Site Number 4845003

    Morelia, 58260

  • Investigational Site Number 4845002

    Querétaro, 76000

  • Investigational Site Number 4845005

    Xalapa, 91020

Other trials in Mexico

Spain8 sites

  • Investigational Site Number 7245005

    Barcelona, 08035

  • Investigational Site Number 7245007

    Barcelona, 08036

  • Investigational Site Number 7245003

    Ferrol, 15405

  • Investigational Site Number 7245009

    Granada, 18012

  • Investigational Site Number 7245006

    Madrid, 28041

  • Investigational Site Number 7245004

    Málaga, 29010

  • Investigational Site Number 7245001

    Seville, 41009

  • Investigational Site Number 7245002

    Zaragoza, 50009

Other trials in Spain

Israel7 sites

  • Investigational Site Number 3765002

    Ashkelon, 78278

  • Investigational Site Number 3765001

    Haifa, 31096

  • Investigational Site Number 3765007

    Kfar Saba, 44281

  • Investigational Site Number 3765005

    Ramat Gan, 52621

  • Investigational Site Number 3765004

    Rehovot, 7642001

  • Investigational Site Number 3765006

    Safed, 13100

  • Investigational Site Number 3765003

    Tel Aviv, 61480

Other trials in Israel

Italy6 sites

  • Investigational Site Number 3805003

    Catania, 95123

  • Investigational Site Number 3805005

    Milan, 20132

  • Investigational Site Number 3805006

    Naples, 00181

  • Investigational Site Number 3805002

    Naples, 80138

  • Investigational Site Number 3805001

    Pavia, 27100

  • Investigational Site Number 3805004

    Roma, 00168

Other trials in Italy

Romania6 sites

  • Investigational Site Number 6425005

    Bacau, 600238

  • Investigational Site Number 6425002

    Bucharest, 010825

  • Investigational Site Number 6425003

    Bucharest, 020475

  • Investigational Site Number 6425007

    Hunedoara, 331057

  • Investigational Site Number 6425004

    Lasi, 700503

  • Investigational Site Number 6425001

    Târgu Mureş, 540142

Other trials in Romania

Ukraine6 sites

  • Investigational Site Number 8045004

    Chernivtsi, 58022

  • Investigational Site Number 8045006

    Kiev, 02002

  • Investigational Site Number 8045007

    Kyiv, 02091

  • Investigational Site Number 8045003

    Kyiv, 04050

  • Investigational Site Number 8045001

    Kyiv, 3037

  • Investigational Site Number 8045002

    Zaporizhzhya, 69600

Other trials in Ukraine

Poland5 sites

  • Investigational Site Number 6165003

    Krakow, 31-209

  • Investigational Site Number 6165002

    Lodz, 92-213

  • Investigational Site Number 6165004

    Oświęcim, 32-600

  • Investigational Site Number 6165005

    Puławy, 24-100

  • Investigational Site Number 6165001

    Rzeszów, 35-055

Other trials in Poland

Russia5 sites

  • Investigational Site Number 6435004

    Chelyabinsk, 4540

  • Investigational Site Number 6435005

    Kemerovo, 650002

  • Investigational Site Number 6435003

    Krasnodar, 350032

  • Investigational Site Number 6435006

    Novosibirsk, 630091

  • Investigational Site Number 6435001

    Saint Petersburg, 194358

Other trials in Russia

Brazil4 sites

  • Investigational Site Number 0765003

    Belém, 66073-005

  • Investigational Site Number 0765001

    Fortaleza, 60170-195

  • Investigational Site Number 0765004

    Rio de Janeiro, 22271-100

  • Investigational Site Number 0765002

    São Paulo, 01244-030

Other trials in Brazil

Colombia4 sites

  • Investigational Site Number 1705004

    Barranquilla, 80020

  • Investigational Site Number 1705005

    Bogotá, 110221

  • Investigational Site Number 1705002

    Manizales, 170004

  • Investigational Site Number 1705001

    Zipaquirá, 250252

Other trials in Colombia

South Africa4 sites

  • Investigational Site Number 7105003

    Cape Town, 7505

  • Investigational Site Number 7105004

    Cape Town, 7570

  • Investigational Site Number 7105001

    Johannesburg, 2188

  • Investigational Site Number 7105002

    Pretoria, 0002

Other trials in South Africa

Argentina3 sites

  • Investigational Site Number 0325001

    Buenos Aires, C1425DES

  • Investigational Site Number 0325003

    Launs Este, B1824KAJ

  • Investigational Site Number 0325004

    Mar del Plata, B7600

Other trials in Argentina

Germany3 sites

  • Investigational Site Number 2765001

    Frankfurt am Main, 60596

  • Investigational Site Number 2765003

    Hanover, 30625

  • Investigational Site Number 2765004

    Münster, 48145

Other trials in Germany

Hungary3 sites

  • Investigational Site Number 3485005

    Baja, 6500

  • Investigational Site Number 3485007

    Debrecen, 4032

  • Investigational Site Number 3485004

    Pécs, 7624

Other trials in Hungary

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 Severe Renal Impairment Who Have Inadequate Glycemic Control

Primary Objective:

To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment

Secondary Objectives:

  • To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c
  • To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo
  • To evaluate the safety of sotagliflozin 400 mg and 200 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.

  • SotagliflozinDrug

    Also called SAR439954

    Sotagliflozin 200 mg, tablet, orally, once daily.

Study groups in NCT03242018
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFollowing a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 milligrams [mg] in appearance) orally once daily for up to 56 weeks.
Receives: Drug: Placebo
Sotagliflozin 200 mgExperimentalFollowing a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 56 weeks.
Receives: Drug: Placebo; Drug: Sotagliflozin
Sotagliflozin 400 mgExperimentalFollowing a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56 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 Comparing Sotagliflozin 400 mg Versus Placebo

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

    Measured: Baseline to Week 26

Secondary outcomes (9)

  1. Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 26

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 26

  3. Change From Baseline in Body Weight at Week 26

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 26

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 12

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 12

  6. 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

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

    Measured: Week 26

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

    Measured: Week 26

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

    An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).

    Measured: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 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 completion16 May 2019
  4. Study completion11 Dec 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03242018
Sponsor's protocol ID
EFC15166
Other IDs
2016-004906-32, U1111-1190-7589, 2016
Acronym
SOTA-CKD4
Status last verified
Jun 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

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PubMed 38770818

  • Cherney DZI, Ferrannini E, Umpierrez GE, Peters AL, Rosenstock J, Carroll AK, Lapuerta P, Banks P, Agarwal R. Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment. Diabetes Obes Metab. 2021 Dec;23(12):2632-2642. doi: 10.1111/dom.14513. Epub 2021 Aug 20.

    PubMed 34338408

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 4, run by Lexicon Pharmaceuticals at 106 sites in 15 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 106 sites in United States, Mexico, Spain, Israel, Italy and 10 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 Comparing Sotagliflozin 400 mg Versus Placebo (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 NCT03242018, which also lists 2 linked publications.

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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