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Type 1 Diabetes Mellitus (T1DM)Phase 3inTandem3NCT02531035

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

A Phase 3 study testing Sotagliflozin in people with Type 1 Diabetes Mellitus (T1DM) and High Level of Sugar (Glucose) in the Blood, run by Lexicon Pharmaceuticals at 135 sites in 19 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

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D). 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
1,405 participants
Where
135 sitesin 19 countries
Study dates
Sep 2015to Apr 2017
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 had given written informed consent to participate in the study in accordance with local regulations
  • Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
  • Participants were being treated with insulin or insulin analog
  • Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
  • At the Screening Visit, A1C was between 7.0% to 11.0%
  • Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test

Who cannot join

  • Use of antidiabetic agent other than insulin or insulin analog at the time of screening
  • Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening
  • Chronic systemic corticosteroid use
  • Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator

Trial locations and contacts

135 sites in 19 countries.

135 sites in 19 countries

United States33 sites

  • Lexicon Investigational Site

    Albany, New York, 12206

  • Lexicon Investigational Site

    Asheville, North Carolina, 28803

  • Lexicon Investigational Site

    Atlanta, Georgia, 30318

  • Lexicon Investigational Site

    Aurora, Colorado, 80045

  • Lexicon Investigational Site

    Austin, Texas, 78731

  • Lexicon Investigational Site

    Bend, Oregon, 97701

  • Lexicon Investigational Site

    Bloomfield Hills, Michigan, 48302

  • Lexicon Investigational Site

    Boston, Massachusetts, 02215

  • Lexicon Investigational Site

    Chapel Hill, North Carolina, 27517

  • Lexicon Investigational Site

    Concord, California, 94520

  • Lexicon Investigational Site

    Escondido, California, 92025

  • Lexicon Investigational Site

    Grand Forks, North Dakota, 58201

  • Lexicon Investigational Site

    Greenville, North Carolina, 27834

  • Lexicon Investigational Site

    La Jolla, California, 92037

  • Lexicon Investigational Site

    Las Vegas, Nevada, 89148

  • Lexicon Investigational Site

    Macon, Georgia, 31210

  • Lexicon Investigational Site

    Morehead City, North Carolina, 28557

  • Lexicon Investigational Site

    New Haven, Connecticut, 06511

  • Lexicon Investigational Site

    New Orleans, Louisiana, 70112

  • Lexicon Investigational Site

    Omaha, Nebraska, 68114

  • Lexicon Investigational Site

    Orlando, Florida, 32804

  • Lexicon Investigational Site

    Rockville, Maryland, 20852

  • Lexicon Investigational Site

    Roswell, Georgia, 30076

  • Lexicon Investigational Site

    Salt Lake City, Utah, 84107

  • Lexicon Investigational Site

    San Antonio, Texas, 78229

  • Lexicon Investigational Site

    San Marcos, California, 94401

  • Lexicon Investigational Site

    Seattle, Washington, 98105

  • Lexicon Investigational Site

    Shavano Park, Texas, 78231

  • Lexicon Investigational Site

    Sioux Falls, South Dakota, 57104

  • Lexicon Investigational Site

    The Bronx, New York, 10467

  • Lexicon Investigational Site

    Ventura, California, 93003

  • Lexicon Investigational Site

    Walnut Creek, California, 94598

  • Lexicon Investigational Site

    West Palm Beach, Florida, 33401

Other trials in United States

Canada10 sites

  • Lexicon Investigational Site

    Barrie, Ontario, L4M 7G1

  • Lexicon Investigational Site

    Halifax, Nova Scotia, B3H 2Y9

  • Lexicon Investigational Site

    London, Ontario, N6A 4V2

  • Lexicon Investigational Site

    Markham, Ontario, L6B 0P9

  • Lexicon Investigational Site

    Oakville, Ontario, L6M 1M1

  • Lexicon Investigational Site

    Saint-Laurent, Quebec, H4T 1Z9

  • Lexicon Investigational Site

    Sherbrooke, Quebec, J1G 5K2

  • Lexicon Investigational Site

    Thornhill, Ontario, L4J 8L7

  • Lexicon Investigational Site

    Toronto, Ontario, M4G 3E8

  • Lexicon Investigational Site

    Vancouver, British Columbia, V5Y 3W2

Other trials in Canada

Australia9 sites

  • Lexicon Investigational Site

    Box Hill, Victoria, 3128

  • Lexicon Investigational Site

    Coffs Harbour, New South Wales, 2450

  • Lexicon Investigational Site

    Fitzroy, Victoria, 3065

  • Lexicon Investigational Site

    Herston, Queensland, 4029

  • Lexicon Investigational Site

    Keswick, South Australia, 5035

  • Lexicon Investigational Site

    Merewether, New South Wales, 2291

  • Lexicon Investigational Site

    Parkville, Victoria, 3050

  • Lexicon Investigational Site

    St Leonards, New South Wales, 2065

  • Lexicon Investigational Site

    Wollongong, New South Wales, 2500

Other trials in Australia

Hungary8 sites

  • Lexicon Investigational Site

    Budapest, 1027

  • Lexicon Investigational Site

    Budapest, 1033

  • Lexicon Investigational Site

    Budapest, 1088

  • Lexicon Investigational Site

    Budapest, 1213

  • Lexicon Investigational Site

    Eger, 3300

  • Lexicon Investigational Site

    Esztergom, 2500

  • Lexicon Investigational Site

    Győr, 9023

  • Lexicon Investigational Site

    Sátoraljaújhely, 3980

Other trials in Hungary

New Zealand7 sites

  • Lexicon Investigational Site

    Christchurch, Canterbury, 8001

  • Lexicon Investigational Site

    Christchurch, 8011

  • Lexicon Investigational Site

    Dunedin, Otago, 9016

  • Lexicon Investigational Site

    Epsom, Auckland, 1051

  • Lexicon Investigational Site

    Newtown, Wellington Region, 6021

  • Lexicon Investigational Site

    Otahuhu, 1640

  • Lexicon Investigational Site

    Takapuna, Auckland, 0620

Other trials in New Zealand

Poland7 sites

  • Lexicon Investigational Site

    Gdynia, 81-338

  • Lexicon Investigational Site

    Katowice, 40-060

  • Lexicon Investigational Site

    Katowice, 40-954

  • Lexicon Investigational Site

    Lublin, 20-538

  • Lexicon Investigational Site

    Warsaw, 01-868

  • Lexicon Investigational Site

    Warsaw, 02-507

  • Lexicon Investigational Site

    Warsaw, 04-736

Other trials in Poland

South Africa7 sites

  • Lexicon Investigational Site

    Bloemfontein, 9300

  • Lexicon Investigational Site

    Cape Town, 7130

  • Lexicon Investigational Site

    Cape Town, 7580

  • Lexicon Investigational Site

    Goodwood, Cape Town, 7460

  • Lexicon Investigational Site

    Johannesburg, 2198

  • Lexicon Investigational Site

    Middelburg, Mpumalanga, 1055

  • Lexicon Investigational Site

    Port Elizabeth, 6045

Other trials in South Africa

Bulgaria6 sites

  • Lexicon Investigational Site

    Plovdiv, 4002

  • Lexicon Investigational Site

    Rousse, 7003

  • Lexicon Investigational Site

    Smolyan, 4700

  • Lexicon Investigational Site

    Sofia, 1431

  • Lexicon Investigational Site

    Sofia, 1750

  • Lexicon Investigational Site

    Varna, 9000

Other trials in Bulgaria

Czechia6 sites

  • Lexicon Investigational Site

    Krnov, 794 01

  • Lexicon Investigational Site

    Olomouc, 779 00

  • Lexicon Investigational Site

    Ostrava, 702 00

  • Lexicon Investigational Site

    Prague, 104 00

  • Lexicon Investigational Site

    Prague, 149 00

  • Lexicon Investigational Site

    Prague, 150 98

Other trials in Czechia

Italy6 sites

  • Lexicon Investigational Site

    Bologna, 40138

  • Lexicon Investigational Site

    Catania, 95122

  • Lexicon Investigational Site

    Catania, 95123

  • Lexicon Investigational Site

    Latina, 04100

  • Lexicon Investigational Site

    Milan, 20132

  • Lexicon Investigational Site

    Rome, 00128

Other trials in Italy

Germany5 sites

  • Lexicon Investigational Site

    Aschaffenburg, 63739

  • Lexicon Investigational Site

    Aßlar, 35614

  • Lexicon Investigational Site

    Mainz, Palatinate, 55116

  • Lexicon Investigational Site

    Münster, Westphalia, 48153

  • Lexicon Investigational Site

    Sulzbach, Rosenberg Bavaria, 92237

Other trials in Germany

Israel5 sites

  • Lexicon Investigational Site

    Holon, 58100

  • Lexicon Investigational Site

    Petach-Tikvah, 4920235

  • Lexicon Investigational Site

    Petah Tikva, 4941492

  • Lexicon Investigational Site

    Rehovot, 76100

  • Lexicon Investigational Site

    Tel HaShomer, 56261

Other trials in Israel

Spain5 sites

  • Lexicon Investigational Site

    Barcelona, 08035

  • Lexicon Investigational Site

    Barcelona, 08036

  • Lexicon Investigational Site

    Málaga, 29006

  • Lexicon Investigational Site

    Seville, 41009

  • Lexicon Investigational Site

    Seville, 41071

Other trials in Spain

United Kingdom5 sites

  • Lexicon Investigational Site

    Blackburn, BB2 3HH

  • Lexicon Investigational Site

    Dundee, Scotland, DD1 9SY

  • Lexicon Investigational Site

    Guildford, GU2 7XX

  • Lexicon Investigational Site

    Leicester, LE5 4PW

  • Lexicon Investigational Site

    Northampton, NN1 5BD

Other trials in United Kingdom

Colombia4 sites

  • Lexicon Investigational Site

    Atlántico, 080020

  • Lexicon Investigational Site

    Cundinamarca, 110221

  • Lexicon Investigational Site

    Cundinamarca, 111211

  • Lexicon Investigational Site

    Cundinamarca, 111311

Other trials in Colombia

Slovakia4 sites

  • Lexicon Investigational Site

    Bardejov, 085 01

  • Lexicon Investigational Site

    Bratislava, 851 01

  • Lexicon Investigational Site

    Bratislava, 85101

  • Lexicon Investigational Site

    Levice, 934 01

Other trials in Slovakia

Argentina3 sites

  • Lexicon Investigational Site

    Buenos Aires, B7600FZN

  • Lexicon Investigational Site

    Buenos Aires, C1180AAX

  • Lexicon Investigational Site

    Córdoba, Córdoba Province, X5006IKK

Other trials in Argentina

Belgium3 sites

  • Lexicon Investigational Site

    Aalst, 9300

  • Lexicon Investigational Site

    Ghent, 9000

  • Lexicon Investigational Site

    Sint-Niklaas, 9100

Other trials in Belgium

France2 sites

  • Lexicon Investigational Site

    Corbeil-Essonnes, 91106

  • Lexicon Investigational Site

    Pierre-Bénite, 69495

Other trials in France

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Being tested
Sotagliflozin, Placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • SotagliflozinDrug

    Also called LX4211

    Sotagliflozin, once daily, before the first meal of the day

  • PlaceboDrug

    Placebo, once daily, before the first meal of the day

Study groups in NCT02531035
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTwo placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
Receives: Drug: Placebo
Sotagliflozin 400 mgExperimentalSotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
Receives: Drug: Sotagliflozin

What is being measured

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

  1. Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization

    The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value <7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.

    Measured: Week 24

Secondary outcomes (4)

  1. Change From Baseline in A1C

    Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement.

    Measured: Baseline to Week 24

  2. Absolute Change From Baseline in Body Weight

    Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.

    Measured: Baseline to Week 24

  3. Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)

    An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16.

    Measured: Baseline to Week 16

  4. Percent Change From Baseline in Mean Daily Bolus Insulin Dose

    The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24.

    Measured: Baseline to Week 24

Timeline

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

  1. First posted21 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionApr 2017
  4. Study completionApr 2017

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
1,405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02531035
Sponsor's protocol ID
LX4211.1-312-T1DM
Other IDs
LX4211.312
Acronym
inTandem3
Status last verified
Feb 2020
First submitted
20 Aug 2015
Last updated
12 Feb 2020
Data monitoring committee
Yes

Publications

  • Garg SK, Henry RR, Banks P, Buse JB, Davies MJ, Fulcher GR, Pozzilli P, Gesty-Palmer D, Lapuerta P, Simo R, Danne T, McGuire DK, Kushner JA, Peters A, Strumph P. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med. 2017 Dec 14;377(24):2337-2348. doi: 10.1056/NEJMoa1708337. Epub 2017 Sep 13.

    PubMed 28899222

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin in people with Type 1 Diabetes Mellitus (T1DM) and High Level of Sugar (Glucose) in the Blood, run by Lexicon Pharmaceuticals at 135 sites in 19 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 6 inclusion and 4 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, Canada, Australia, Hungary, New Zealand and 14 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 19 Nov 2019). 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?

Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization (time frame: Week 24). 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 NCT02531035, 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 12 Feb 2020.

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