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Type 2 Diabetes MellitusPhase 3SOTA-INSNCT03285594

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

A Phase 3 study testing Sotagliflozin, Insulin glargine (HOE901) and Oral Antidiabetes Drugs (OADs) in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 106 sites in 8 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 in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Sotagliflozin, Insulin glargine (HOE901) and Oral Antidiabetes Drugs (OADs)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
571 participants
Where
106 sitesin 8 countries
Study dates
15 Sep 2017to 27 Sep 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 Mellitus (T2DM) using any types of basal insulin alone or in combination with up to 2 OADs.
  • Participants have given written informed consent to participate in the study in accordance with local regulations.

Who cannot join

  • At the time of Screening age <18 years or <legal age of majority, whichever is greater.
  • Type 1 diabetes mellitus.
  • Oral antidiabetic drugs dose not stable for 8 weeks before Screening.
  • Use of basal insulin therapy (e.g., insulin glargine, Neutral Protamine Hagedorn (NPH), detemir, or degludec) for less than 6 months before Screening.
  • Dose of basal insulin (e.g., insulin glargine, NPH, detemir, or degludec) not stable for 8 weeks before Screening (i.e., total daily insulin dose increased or decreased by more than 20%).
  • Known unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema that is likely to require laser, surgical treatment during study period.
Show all 24Show fewer
  • Use of injectable diabetes drugs other than basal insulin (e.g., insulin glargine, NPH, detemir, or degludec), i.e., prandial or rapid-acting insulins, short-acting insulins, glucagon-like peptide 1 (GLP-1) receptor agonists, or inhaled prandial insulin (Afrezza) within 8 weeks of Screening.
  • Use of a selective sodium-glucose cotransporter type 2 (SGLT2) inhibitor (e.g., canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to the trial.
  • Use of systemic glucocorticoids (excluding topical, intra articular, or ophthalmic application, nasal spray or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
  • 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 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.
  • Known presence of factors that interfere with the Central Lab HbA1c measurement (e.g., genetic hemoglobin (Hb) variants) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (e.g., blood transfusion or severe blood loss in the last 3 months prior to randomization, any condition that shortens erythrocyte survival).
  • Participants who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives from prior to Screening, whichever is longer.
  • Participants unwilling to perform self-monitoring of blood glucose (SMBG), complete the patient diary, or comply with study visits and other study procedures as required per protocol.
  • HbA1c <7.5% or HbA1c >10.5% measured by the central laboratory at Screening.
  • HbA1c <7% measured by the central laboratory at Visit 5 (Week -1).
  • History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
  • Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women.
  • Women of childbearing potential 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.
  • Mean of 3 separate blood pressure measurements >180 mmHg (systolic blood pressure [SBP]) or >100 mmHg (diastolic blood pressure [DBP]).
  • History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the Screening Visit.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal laboratory range
  • Total bilirubin >1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome).
  • 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 8 countries.

106 sites in 8 countries

United States50 sites

  • Investigational Site Number 8406034

    Asheville, North Carolina, 28803

  • Investigational Site Number 8406031

    Beachwood, Ohio, 44122

  • Investigational Site Number 8406046

    Chapel Hill, North Carolina, 27517

  • Investigational Site Number 8406026

    Charlotte, North Carolina, 28209

  • Investigational Site Number 8406009

    Chattanooga, Tennessee, 37421

  • Investigational Site Number 8406054

    Chicago, Illinois, 60602

  • Investigational Site Number 8406027

    Chicago, Illinois, 60604

  • Investigational Site Number 8406023

    Columbus, Ohio, 43201

  • Investigational Site Number 8406043

    Coral Gables, Florida, 33134

  • Investigational Site Number 8406047

    Dallas, Texas, 75230

  • Investigational Site Number 8406017

    Dallas, Texas, 75231

  • Investigational Site Number 8406008

    DeLand, Florida, 32720

  • Investigational Site Number 8406016

    Detroit, Michigan, 48202

  • Investigational Site Number 8406005

    Dublin, Ohio, 43016

  • Investigational Site Number 8406042

    Evansville, Indiana, 47714

  • Investigational Site Number 8406038

    Greenville, North Carolina, 27834

  • Investigational Site Number 8406036

    Hickory, North Carolina, 28601

  • Investigational Site Number 8406048

    Houston, Texas, 77079

  • Investigational Site Number 8406037

    Houston, Texas, 77099

  • Investigational Site Number 8406006

    Huntington Park, California, 90255

  • Investigational Site Number 8406053

    Lincoln, California, 95648

  • Investigational Site Number 8406040

    Los Angeles, California, 90057

  • Investigational Site Number 8406030

    Maitland, Florida, 32751

  • Investigational Site Number 8406039

    McAllen, Texas, 78504

  • Investigational Site Number 8406004

    Mentor, Ohio, 44060

  • Investigational Site Number 8406028

    Mesa, Arizona, 85213-5226

  • Investigational Site Number 8406032

    Moncks Corner, South Carolina, 29461-5017

  • Investigational Site Number 8406044

    New Orleans, Louisiana, 70119-6302

  • Investigational Site Number 8406051

    New Orleans, Louisiana, 70124

  • Investigational Site Number 8406003

    New Port Richey, Florida, 34652

  • Investigational Site Number 8406018

    New York, New York, 10016-6023

  • Investigational Site Number 8406029

    North Miami Beach, Florida, 33162

  • Investigational Site Number 8406052

    Ocoee, Florida, 34761

  • Investigational Site Number 8406033

    Oklahoma City, Oklahoma, 73111

  • Investigational Site Number 8406010

    Papillion, Nebraska, 68046-3136

  • Investigational Site Number 8406013

    Phoenix, Arizona, 85018

  • Investigational Site Number 8406020

    Phoenix, Arizona, 85020

  • Investigational Site Number 8406001

    Port Charlotte, Florida, 33952

  • Investigational Site Number 8406024

    Rockville, Maryland, 20852

  • Investigational Site Number 8406035

    Salt Lake City, Utah, 84102-1553

  • Investigational Site Number 8406050

    San Antonio, Texas, 78229

  • Investigational Site Number 8406045

    Seymour, Tennessee, 37865-5270

  • Investigational Site Number 8406021

    Shavano Park, Texas, 78231

  • Investigational Site Number 8406011

    St Louis, Missouri, 63110

  • Investigational Site Number 8406022

    St. Petersburg, Florida, 33700

  • Investigational Site Number 8406025

    Tampa, Florida, 33634

  • Investigational Site Number 8406014

    West Jordan, Utah, 84088-8865

  • Investigational Site Number 8406002

    West Palm Beach, Florida, 33401-3430

  • Investigational Site Number 8406015

    Wilmington, North Carolina, 28401-6638

  • Investigational Site Number 8406019

    Winston-Salem, North Carolina, 27103

Other trials in United States

France11 sites

  • Investigational Site Number 2506008

    Besançon, 25030

  • Investigational Site Number 2506003

    Corbeil-Essonnes, 91106

  • Investigational Site Number 2506005

    Dijon, 21079

  • Investigational Site Number 2506012

    Mulhouse, 68100

  • Investigational Site Number 2506004

    Nantes, 44093

  • Investigational Site Number 2506007

    Narbonne, 11100

  • Investigational Site Number 2506006

    Paris, 75018

  • Investigational Site Number 2506010

    Pierre-Bénite, 69495

  • Investigational Site Number 2506009

    Poitiers, 86021

  • Investigational Site Number 2506011

    Saint-Mandé, 94160

  • Investigational Site Number 2506002

    Vénissieux, 69200

Other trials in France

Slovakia10 sites

  • Investigational Site Number 7036004

    Bardejov, 085 01

  • Investigational Site Number 7036008

    Bratislava, 831 06

  • Investigational Site Number 7036001

    Bratislava, 85101

  • Investigational Site Number 7036010

    Košice, 040 01

  • Investigational Site Number 7036003

    Košice, 4014

  • Investigational Site Number 7036007

    Levice, 934 01

  • Investigational Site Number 7036009

    Levice, 934 05

  • Investigational Site Number 7036011

    Lučenec, 98401

  • Investigational Site Number 7036006

    Nitra, 949 11

  • Investigational Site Number 7036005

    Sabinov, 08301

Other trials in Slovakia

Bulgaria9 sites

  • Investigational Site Number 1006009

    Gabrovo, 5300

  • Investigational Site Number 1006003

    Plovdiv, 4002

  • Investigational Site Number 1006004

    Rousse, 7002

  • Investigational Site Number 1006001

    Rousse, 7003

  • Investigational Site Number 1006006

    Smolyan, 4700

  • Investigational Site Number 1006002

    Sofia, 1606

  • Investigational Site Number 1006010

    Sofia, 1750

  • Investigational Site Number 1006005

    Stara Zagora, 6000

  • Investigational Site Number 1006007

    Varna, 9000

Other trials in Bulgaria

Hungary8 sites

  • Investigational Site Number 3486007

    Budapest, 1106

  • Investigational Site Number 3486002

    Budapest, 1134

  • Investigational Site Number 3486006

    Hatvan, 3000

  • Investigational Site Number 3486009

    Kecskemét, 6000

  • Investigational Site Number 3486003

    Komárom, 2900

  • Investigational Site Number 3486005

    Nyíregyháza, 4400

  • Investigational Site Number 3486001

    Pécs, 7623

  • Investigational Site Number 3486008

    Zalaegerszeg, 8900

Other trials in Hungary

Czechia7 sites

  • Investigational Site Number 2036003

    Holešov, 769 01

  • Investigational Site Number 2036002

    Krnov, 794 01

  • Investigational Site Number 2036001

    Olomouc, 779 00

  • Investigational Site Number 2036005

    Ostrava, 702 00

  • Investigational Site Number 2036007

    Prague, 140 46

  • Investigational Site Number 2036008

    Prague, 149 00

  • Investigational Site Number 2036006

    Praha 10 - Uhrineves, 104 00

Other trials in Czechia

United Kingdom6 sites

  • Investigational Site Number 8266002

    Darlington, DL3 6HX

  • Investigational Site Number 8266006

    Doncaster, DN9 2HY

  • Investigational Site Number 8266008

    Dundee, DD1 9SY

  • Investigational Site Number 8266001

    Leicester, LE5 4PW

  • Investigational Site Number 8266004

    London, EC1M 6BQ

  • Investigational Site Number 8266003

    Salford, M6 8HD

Other trials in United Kingdom

Canada5 sites

  • Investigational Site Number 1246003

    Brampton, L6S 0C9

  • Investigational Site Number 1246005

    Burlington, L7R 1E2

  • Investigational Site Number 1246004

    Etobicoke, M9R 4E1

  • Investigational Site Number 1246002

    Toronto, M4G 3E8

  • Investigational Site Number 1246001

    Vancouver, V5Y 3W2

Other trials in Canada

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)

Primary Objective:

To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1C (HbA1c) reduction in participants with type 2 diabetes mellitus (T2D) who have inadequate glycemic control on basal insulin alone or with oral antidiabetes drugs (OADs).

Secondary Objectives:

  • To assess the effects of sotagliflozin 400 mg versus placebo on fasting plasma glucose (FPG), body weight, systolic blood pressure (SBP), and HbA1c.
  • To assess the effects of sotagliflozin 200 mg versus placebo on HbA1c, body weight, FPG, and SBP.
  • To evaluate the safety of sotagliflozin 400 and 200 mg versus placebo.
Read the detailed description

Up to 60 weeks (Screening phase of up to 2 weeks, a 4-week Lantus titration/single-blind placebo Run-in phase), a 52-week double blind Treatment Period, and a 2-week post-treatment Follow-up Period.

Being tested
Sotagliflozin, Insulin glargine (HOE901), Placebo, Oral Antidiabetes Drugs (OADs)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • SotagliflozinDrug

    Also called SAR439954

    Pharmaceutical form: Tablet

    Route of administration: Oral

  • Insulin glargine (HOE901)Drug

    Also called Lantus

    Pharmaceutical form: Solution

    Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form: Tablet

    Route of administration: Oral

  • Oral Antidiabetes Drugs (OADs)Drug

    OADs (including metformin) as prescribed by the investigator as per local labeling.

Study groups in NCT03285594
Study groupRoleWhat they receive
PlaceboPlacebo comparatorFollowing a 4-week run-in period, participants were randomized to matching placebo to sotagliflozin 200 milligrams (mg) administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Receives: Drug: Insulin glargine (HOE901); Drug: Placebo; Drug: Oral Antidiabetes Drugs (OADs)
Sotagliflozin 200 mgExperimentalFollowing a 4-week run-in period, participants were randomized to sotagliflozin 200 mg administered as 1 tablet and matching placebo as 1 tablet, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Receives: Drug: Sotagliflozin; Drug: Insulin glargine (HOE901); Drug: Placebo; Drug: Oral Antidiabetes Drugs (OADs)
Sotagliflozin 400 mgExperimentalFollowing a 4-week run-in period, participants were randomized to sotagliflozin 400 mg administered as 2 tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 52 weeks. Background therapy with insulin glargine (with or without OADs) continued throughout the study.
Receives: Drug: Sotagliflozin; Drug: Insulin glargine (HOE901); Drug: Oral Antidiabetes Drugs (OADs)

What is being measured

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

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18

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

    Measured: Baseline and Week 18

Secondary outcomes (7)

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18

    FPG was performed in fasting state, that is, without any food intake (except for water) for at least 8 hours. An ANCOVA model was used for the analysis.

    Measured: Baseline and Week 18

  2. Change From Baseline in Body Weight at Week 18

    An ANCOVA model was used for the analysis.

    Measured: Baseline and Week 18

  3. Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12

    An ANCOVA model was used for the analysis. Here, N is the number of participants with data available at a given time point.

    Measured: Baseline and Week 12

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline to Week 12

  5. Change From Baseline in HbA1c at Week 52

    An ANCOVA model was used for the analysis.

    Measured: Baseline and Week 52

  6. Change From Baseline in Body Weight at Week 52

    An ANCOVA model was used for the analysis.

    Measured: Baseline and Week 52

  7. Percentage of Participants With Adverse Events (AEs)

    An 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 this treatment.

    Measured: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks

Timeline

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

  1. First posted18 Sep 2017
  2. Study start15 Sep 2017
  3. Primary completion17 Sep 2019
  4. Study completion27 Sep 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
Double blind
Who is masked
Participant, Investigator
Enrolment
571 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03285594
Sponsor's protocol ID
EFC14868
Other IDs
2016-001804-43, U1111-1190-7567, 2016
Acronym
SOTA-INS
Status last verified
Apr 2021
First submitted
14 Sep 2017
Last updated
11 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin, Insulin glargine (HOE901) and Oral Antidiabetes Drugs (OADs) in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 106 sites in 8 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 24 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 11 May 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, France, Slovakia, Bulgaria, Hungary and 3 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 11 May 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 Hemoglobin A1c (HbA1c) at Week 18 (time frame: Baseline and Week 18). 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 NCT03285594.

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 11 May 2021.

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