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Type 1 Diabetes MellitusPhase 3inTandem2NCT02421510

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

A Phase 3 study testing Sotagliflozin in people with Type 1 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 96 sites in 17 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 intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
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
782 participants
Where
96 sitesin 17 countries
Study dates
May 2015to 23 Jun 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

  • Participant who gave written informed consent to participate in the study in accordance with local regulations.
  • Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
  • Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
  • Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol.
  • At the Screening Visit, A1C was between 7.0% to 11.0%.
  • Females of childbearing potential must use an adequate method of contraception and have 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

96 sites in 17 countries.

96 sites in 17 countries

Poland9 sites

  • Lexicon Investigational Site

    Katowice, 40-060

  • Lexicon Investigational Site

    Krakow, 30-015

  • Lexicon Investigational Site

    Lodz, 90-242

  • Lexicon Investigational Site

    Lublin, 20-538

  • Lexicon Investigational Site

    Poznan, 61-655

  • Lexicon Investigational Site

    Szczecin, 70-506

  • Lexicon Investigational Site

    Warsaw, 01-518

  • Lexicon Investigational Site

    Warsaw, 02-507

  • Lexicon Investigational Site

    Warsaw, 04-736

Other trials in Poland

Spain9 sites

  • Lexicon Investigational Site

    Barcelona, 08035

  • Lexicon Investigational Site

    Barcelona, 08036

  • Lexicon Investigational Site

    Granada, 18012

  • Lexicon Investigational Site

    Málaga, 29006

  • Lexicon Investigational Site

    Seville, 41003

  • Lexicon Investigational Site

    Seville, 41009

  • Lexicon Investigational Site

    Seville, 41010

  • Lexicon Investigational Site

    Seville, 41014

  • Lexicon Investigational Site

    Valencia, 46014

Other trials in Spain

Hungary8 sites

  • Lexicon Investigational Site

    Budapest, 1027

  • Lexicon Investigational Site

    Budapest, 1042

  • Lexicon Investigational Site

    Budapest, 1097

  • Lexicon Investigational Site

    Budapest, 1106

  • Lexicon Investigational Site

    Budapest, 1134

  • Lexicon Investigational Site

    Gyula, 5700

  • Lexicon Investigational Site

    Hódmezővásárhely, 6800

  • Lexicon Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

Romania8 sites

  • Lexicon Investigational Site

    Bacau, 600238

  • Lexicon Investigational Site

    Bucharest, 010507

  • Lexicon Investigational Site

    Bucharest, 013764

  • Lexicon Investigational Site

    Buzău, 120203

  • Lexicon Investigational Site

    Galati, 800098

  • Lexicon Investigational Site

    Oradea, 410159

  • Lexicon Investigational Site

    Sibiu, 550371

  • Lexicon Investigational Site

    Târgu Mureş, 540142

Other trials in Romania

Germany7 sites

  • Lexicon Investigational Site

    Düsseldorf, 40210

  • Lexicon Investigational Site

    Hamburg, 21073

  • Lexicon Investigational Site

    Hamburg, 22607

  • Lexicon Investigational Site

    Hanover, 30173

  • Lexicon Investigational Site

    Mainz, 55116

  • Lexicon Investigational Site

    Münster, 48145

  • Lexicon Investigational Site

    Neuwied, 56564

Other trials in Germany

Israel7 sites

  • Lexicon Investigational Site

    Haifa, 31096

  • Lexicon Investigational Site

    Holon, 58100

  • Lexicon Investigational Site

    Jerusalem, 91120

  • Lexicon Investigational Site

    Petah Tikva, 49202

  • Lexicon Investigational Site

    Tel Aviv, 61480

  • Lexicon Investigational Site

    Tel HaShomer, 52621

  • Lexicon Investigational Site

    Tsrifin, 70300

Other trials in Israel

United Kingdom7 sites

  • Lexicon Investigational Site

    Birmingham, B15 2TH

  • Lexicon Investigational Site

    Blackburn, BB2 3HH

  • Lexicon Investigational Site

    Bristol, BS10 5NB

  • Lexicon Investigational Site

    Glasgow, G4 0SF

  • Lexicon Investigational Site

    Leeds, LS2 9JT

  • Lexicon Investigational Site

    Leicester, LE5 4PW

  • Lexicon Investigational Site

    Sheffield, S5 7AU

Other trials in United Kingdom

Bulgaria6 sites

  • Lexicon Investigational Site

    Lovech, 5500

  • Lexicon Investigational Site

    Plovdiv, 4002

  • Lexicon Investigational Site

    Rousse, 7002

  • Lexicon Investigational Site

    Smolyan, 4700

  • Lexicon Investigational Site

    Sofia, 1750

  • Lexicon Investigational Site

    Varna, 9000

Other trials in Bulgaria

Italy6 sites

  • Lexicon Investigational Site

    Catania, 95123

  • Lexicon Investigational Site

    Milan, 20132

  • Lexicon Investigational Site

    Palermo, 90127

  • Lexicon Investigational Site

    Perugia, 06126

  • Lexicon Investigational Site

    Pisa, 56124

  • Lexicon Investigational Site

    Roma, 00128

Other trials in Italy

Slovakia6 sites

  • Lexicon Investigational Site

    Bratislava, 821 02

  • Lexicon Investigational Site

    Bratislava, 851 01

  • Lexicon Investigational Site

    Košice, 040 01

  • Lexicon Investigational Site

    Nové Zámky, 940 01

  • Lexicon Investigational Site

    Štúrovo, 943 01

  • Lexicon Investigational Site

    Vrútky, 038 61

Other trials in Slovakia

Austria5 sites

  • Lexicon Investigational Site

    Linz, 4021

  • Lexicon Investigational Site

    Vienna, 1010

  • Lexicon Investigational Site

    Vienna, 1030

  • Lexicon Investigational Site

    Vienna, 1130

  • Lexicon Investigational Site

    Vienna, 1160

Other trials in Austria

Belgium5 sites

  • Lexicon Investigational Site

    Antwerp, 2018

  • Lexicon Investigational Site

    Brussels, 1090

  • Lexicon Investigational Site

    Edegem, 2650

  • Lexicon Investigational Site

    Leuven, 3000

  • Lexicon Investigational Site

    Sint-Niklaas, 9100

Other trials in Belgium

France5 sites

  • Lexicon Investigational Site

    Béziers, 34500

  • Lexicon Investigational Site

    Dijon, 21079

  • Lexicon Investigational Site

    Nantes, 44000

  • Lexicon Investigational Site

    Nantes, 44093

  • Lexicon Investigational Site

    Nîmes, 30029

Other trials in France

Lithuania3 sites

  • Lexicon Investigational Site

    Jonava, LT-55201

  • Lexicon Investigational Site

    Kaunas, LT-49449

  • Lexicon Investigational Site

    Kaunas, LT-50161

Other trials in Lithuania

Sweden3 sites

  • Lexicon Investigational Site

    Härnösand, 871 82

  • Lexicon Investigational Site

    Kristianstad, 291 85

  • Lexicon Investigational Site

    Stockholm, 112 21

Other trials in Sweden

Netherlands1 site

  • Lexicon Investigational Site

    Dordrecht, 3318

Other trials in Netherlands

Switzerland1 site

  • Lexicon Investigational Site

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Being tested
Sotagliflozin, Placebo
Keywords
High level of sugar (glucose) in the blood
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

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

  • SotagliflozinDrug

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

  • PlaceboDrug

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

Study groups in NCT02421510
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTwo placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Receives: Drug: Placebo
Sotagliflozin 200 mgExperimentalSotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Receives: Drug: Sotagliflozin
Sotagliflozin 400 mgExperimentalSotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
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 A1C at Week 24

    Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (<= 8.5%, >8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from baseline (a reduction of A1C value at Week 24) indicates an improvement.

    Measured: Baseline to Week 24

Secondary outcomes (7)

  1. Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24

    The composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value <7.0% and a central blinded adjudication process to determine whether participants experienced either DKA or severe hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.

    Measured: Baseline to Week 24

  2. Change From Baseline in Body Weight at Week 24

    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 Mean Daily Bolus Insulin Dose at Week 24

    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 change from baseline indicated a reduction in the amount of bolus insulin used and a positive change from baseline indicated an increase in the amount of bolus insulin used between baseline and Week 24.

    Measured: Baseline to Week 24

  4. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    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 change from baseline indicates a lower glucose level at Week 24 compared to baseline and a positive change from baseline indicates an increase in glucose level at Week 24 compared to baseline.

    Measured: Baseline to Week 24

  5. Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24

    The DTSQ instrument contains 8 items assessing overall treatment satisfaction, treatment convenience and flexibility, satisfaction with understanding of diabetes, willingness to continue present treatment and to recommend it to others, and frequency of unacceptably high and unacceptably low blood glucose levels. 6 items (1, 4, 5, 6, 7 and 8) (excluding perceived hyperglycemia and hypoglycemia items) were scored using a 7- point scale where 0=very dissatisfied to 6= very satisfied for a total possible score of 0 (very dissatisfied) to 36 (very satisfied), where higher scores indicate higher satisfaction from treatment. Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively. 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 positive change from baseline indicates improvement.

    Measured: Baseline to Week 24

  6. Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24

    DDS2 is a 2-item diabetes distress screening instrument where participants rated the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen using a 6-point scale: where 1=no distress to 6=severe distress for a total possible score of 2 to 12. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement.

    Measured: Baseline to Week 24

  7. Percent Change From Baseline in Body Weight at Week 24

    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 percent change from baseline indicates a loss in body weight from baseline to 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 posted20 Apr 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionNov 2016
  4. Study completion23 Jun 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
782 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02421510
Sponsor's protocol ID
LX4211.1-310-T1DM
Other IDs
LX4211.310, 2014-005153-39, 2014
Acronym
inTandem2
Status last verified
Feb 2020
First submitted
15 Apr 2015
Last updated
12 Feb 2020
Data monitoring committee
Yes

Publications

  • Peters AL, McGuire DK, Danne T, Kushner JA, Rodbard HW, Dhatariya K, Sawhney S, Banks P, Jiang W, Davies MJ, Lapuerta P. Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies. Diabetes Care. 2020 Nov;43(11):2713-2720. doi: 10.2337/dc20-0924. Epub 2020 Sep 14.

    PubMed 32928957

  • Danne T, Joish VN, Afonso M, Banks P, Sawhney S, Lapuerta P, Davies MJ, Buse JB, Lin D, Reaney M, Guillonneau S, Snoek FJ, Bailey TS, Polonsky WH. Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone. Diabetes Technol Ther. 2021 Jan;23(1):70-77. doi: 10.1089/dia.2020.0068.

    PubMed 32721228

  • Ervin C, Joish VN, Evans E, DiBenedetti D, Reaney M, Preblick R, Castro R, Danne T, Buse JB, Lapuerta P. Insights Into Patients' Experience With Type 1 Diabetes: Exit Interviews From Phase III Studies of Sotagliflozin. Clin Ther. 2019 Nov;41(11):2219-2230.e6. doi: 10.1016/j.clinthera.2019.09.003. Epub 2019 Oct 3.

    PubMed 31587812

  • Danne T, Cariou B, Buse JB, Garg SK, Rosenstock J, Banks P, Kushner JA, McGuire DK, Peters AL, Sawhney S, Strumph P. Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program. Diabetes Care. 2019 May;42(5):919-930. doi: 10.2337/dc18-2149. Epub 2019 Mar 4.

    PubMed 30833371

  • Danne T, Cariou B, Banks P, Brandle M, Brath H, Franek E, Kushner JA, Lapuerta P, McGuire DK, Peters AL, Sawhney S, Strumph P. HbA1c and Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study. Diabetes Care. 2018 Sep;41(9):1981-1990. doi: 10.2337/dc18-0342. Epub 2018 Jun 24.

    PubMed 29937431

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin in people with Type 1 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 96 sites in 17 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 96 sites in Poland, Spain, Hungary, Romania, Germany and 12 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 30 Oct 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?

Change From Baseline in A1C at Week 24 (time frame: Baseline to 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 NCT02421510, which also lists 5 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 12 Feb 2020.

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