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TerminatedNCT03386344SOTA-BONEUpdated Jun 25, 2021Results posted

Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

A Phase 3 interventional study of Sotagliflozin and Placebo in Type 2 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals. Terminated at 53 sites in 8 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2021-06-25.

Sponsored by Lexicon Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was terminated
Study terminated prematurely for financial reasons and Covid-19 pandemic.
Phase
Phase 3
Study type
Interventional
Enrollment
376
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 27 studies testing sotagliflozin in Diabetes Mellitus, Type 2 — 2 open to participants now, 2 under way, none of them phase 3. sotagliflozin · Diabetes Mellitus, Type 2.

Enrollment
11th of 27
376 · median 276
Started
2018
with 4 others
Phase 3
13 of 27
none open now
Registered
20th of 27
by date
Lead sponsor
17 of 27
Lexicon Pharmaceuticals

Among the 27 studies testing sotagliflozin in Diabetes Mellitus, Type 2, this one is the 11th largest by enrollment, is one of 5 that started in 2018, is one of 13 in phase 3, and was the 20th registered.

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Open to participants now

2 of the 27 studies testing sotagliflozin in Diabetes Mellitus, Type 2 are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

United States2

All 2 open studies →

About sotagliflozin

sotagliflozin: first FDA approval 2023 (INPEFA), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.

This study: 55 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 27 studies testing sotagliflozin in Diabetes Mellitus, Type 2, or all of them as a file.
02

Study summary

The primary objective is to demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen.

Read the detailed description

Study duration per participant is approximately 110 weeks (Screening period of up to 2 weeks, 2 week single-blind run-in period), a 26-week double-blind core treatment period, a 78-week double-blind extension period, and a 2- week post treatment follow up period.

Dual-energy X-ray absorptiometry (DXA) scans will be performed to assess Bone Mineral Density and Fat vs. Lean body mass at baseline and Weeks 26, 52, and 104.

03

Conditions studied

  • Type 2 Diabetes Mellitus
04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants with T2D managed with diet and exercise only or with a stable antidiabetes regimen (in monotherapy or combination therapy that can include oral antidiabetes medications, insulin, or glucagon-like peptide-1 agonists) for more than 12 weeks.
  • Participants has given written to participate in the study in accordance with local regulations.

Exclusion criteria

Exclusion criteria:

  • Age \<55 years.
  • Women who have been (or undergone bilateral oophorectomy) for less than 5 years.
  • Type 1 diabetes mellitus.
  • (BMI) ≤20 or >45 kilogram per meter square kg/m\^2 or bodyweight that exceeds the weight limits of the DXA scanner.
  • (HbA1c) \<7.0% or HbA1c >11.0%.
  • Use of a selective sodium-glucose cotransporter type 2 (SGLT2) inhibitor or thiazolidinedione within 24 months.
  • Bone mineral density (BMD) T- score \<-2.0 at any site (ie, lumbar spine, total hip, or femoral neck).
  • History of fracture within 12 months (except for fractures of the hand/fingers, foot/toes, facial bones, and skull).
  • Treatment with medications known to affect bone mass or modify the risk of fractures within 36 months (eg, bisphosphonates, selective estrogen receptor modulators, calcitonin, teriparatide, denosumab, strontium ranelate, growth hormone, aromatase inhibitors, androgen deprivation therapy, carbamazepine, phenytoin, and phenobarbital). Use of hormonal replacement that includes systemic or transdermal estrogen or testosterone is excluded unless is stable for at least 24 months prior to Screening.
  • Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at randomization.
  • 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 .
  • Renal disease as defined by an estimated (eGFR) \<30 milliliter per minute (mL/min)/1.73 meter square (m\^2) at the Screening Visit by the 4 variable Modification of Diet in Renal Disease equation.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
376 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Following a 2 week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 106 weeks.

    Drug: Placebo

  • Experimental
    Sotagliflozin 200 mg

    Following a 2 week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.

    Drug: Sotagliflozin · Drug: Placebo

  • Experimental
    Sotagliflozin 400 mg

    Following a 2 week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg sotagliflozin tablets, once daily, before the first meal of the day, for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 104 weeks.

    Drug: Sotagliflozin

Interventions

  • DrugSotagliflozin

    Pharmaceutical form: Tablet; Route of administration: Oral

    Also known as: SAR439954

  • DrugPlacebo

    Pharmaceutical form: Tablet; Route of administration: Oral

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26

    An analysis of covariance (ANCOVA) model is used for analysis.

    Time frame: Baseline to Week 26

Secondary outcomes

  1. Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26

    An ANCOVA model is used for analysis.

    Time frame: Baseline to Week 26

  2. Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26

    An ANCOVA model is used for analysis.

    Time frame: Baseline to Week 26

  3. Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26

    An ANCOVA model is used for analysis.

    Time frame: Baseline to Week 26

  4. Change From Baseline in Body Weight at Week 26

    An ANCOVA model is used for analysis.

    Time frame: Baseline to Week 26

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

    An ANCOVA model is used for analysis.

    Time frame: Baseline to Week 26

  6. Change From Baseline in Systolic Blood Pressure (SBP) at Week 12

    An ANCOVA model is used for analysis.

    Time frame: Baseline to Week 12

  7. Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26

    Time frame: Week 26

  8. Percentage of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

    Time frame: up to 106 weeks

07

Results

Posted Jun 25, 2021

Participant flow

Participants took part in the study at 53 investigative sites in the United States, Australia, Canada, Korea, Republic of Mexico, New Zealand, Russian Federation, and Taiwan from 19 February 2018 to 30 May 2020.

Participant flow — Overall Study
MilestonePlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Started126125125
Completed999
Not completed117116116
Withdrew: Adverse event631
Withdrew: Poor compliance to protocol010
Withdrew: Study terminated by sponsor101102106
Withdrew: Lost to follow-up321
Withdrew: At the participant's own request778
Withdrew: Reason not specified010

Outcome measures

PrimaryChange From Baseline in Hemoglobin A1c (HbA1c) at Week 26

An analysis of covariance (ANCOVA) model is used for analysis.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
percentage of HbA1cPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26-0.22 ± 0.080-0.66 ± 0.077-0.67 ± 0.079
Statistical analysis
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = <0.0001 · Difference in least squares (ls) means: -0.45 · 95% CI -0.649 to -0.250
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = <0.0001 · Difference in ls means: -0.43 · 95% CI -0.634 to -0.235
SecondaryPercent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26

An ANCOVA model is used for analysis.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 26
percent changePlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Week 260.37 ± 0.3270.13 ± 0.3230.22 ± 0.327
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = 0.5707 · Difference in ls means: -0.24 · 95% CI -1.070 to 0.590
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = 0.7247 · Difference in ls means: -0.15 · 95% CI -0.969 to 0.674
SecondaryPercent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26

An ANCOVA model is used for analysis.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26
percent changePlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Week 26-0.36 ± 0.259-0.22 ± 0.220-0.16 ± 0.223
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = 0.6454 · Difference in ls means: 0.14 · 95% CI -0.462 to 0.745
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = 0.5289 · Difference in ls means: 0.19 · 95% CI -0.410 to 0.798
SecondaryPercent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26

An ANCOVA model is used for analysis.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26
percent changePlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Percent Change From Baseline in Bone Mineral Density (BMD) of Femoral Neck at Week 26-0.94 ± 0.379-0.20 ± 0.332-0.62 ± 0.338
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = 0.1050 · Difference in ls means: 0.75 · 95% CI -0.157 to 1.654
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = 0.4804 · Difference in ls means: 0.32 · 95% CI -0.577 to 1.226
SecondaryChange From Baseline in Body Weight at Week 26

An ANCOVA model is used for analysis.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · kilogram (kg)
Change From Baseline in Body Weight at Week 26
kilogram (kg)PlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in Body Weight at Week 26-0.46 ± 0.261-2.37 ± 0.258-2.16 ± 0.264
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = <0.0001 · Difference in ls means: -1.91 · 95% CI -2.568 to -1.252
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = <0.0001 · Difference in ls means: -1.70 · 95% CI -2.360 to -1.046
SecondaryChange From Baseline in Fasting Plasma Glucose (FPG) at Week 26

An ANCOVA model is used for analysis.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · milligram per deciliter (mg/dL)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
milligram per deciliter (mg/dL)PlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26-7.274 ± 3.6064-26.165 ± 3.4656-28.607 ± 3.5912
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = <0.0001 · Difference in ls means: -18.891 · 95% CI -27.8605 to -9.9205
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = <0.0001 · Difference in ls means: -21.333 · 95% CI -30.3294 to -12.3360
SecondaryChange From Baseline in Systolic Blood Pressure (SBP) at Week 12

An ANCOVA model is used for analysis.

Time frame:
Baseline to Week 12
Reported as:
Least squares mean · millimeter of mercury (mmHg)
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
millimeter of mercury (mmHg)PlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12-0.80 ± 1.149-1.61 ± 1.130-1.97 ± 1.165
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = 0.5864 · Difference in ls means: -0.80 · 95% CI -3.705 to 2.095
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = 0.4315 · Difference in ls means: -1.16 · 95% CI -4.058 to 1.734
SecondaryPercentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26
Time frame:
Week 26
Reported as:
Number · percentage of participants
Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 26
percentage of participantsPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% at Week 269.520.021.6
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · Cochran-Mantel-Haenszel · p = 0.0172 · Percentage difference: 10.5 · 95% CI 1.78 to 19.23
  • Placebo vs Sotagliflozin 400 mg · Cochran-Mantel-Haenszel · p = 0.0076 · Percentage difference: 12.0 · 95% CI 3.23 to 20.86
SecondaryPercentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

Time frame:
up to 106 weeks
Reported as:
Number · percentage of participants
Percentage of Participants With Adverse Events (AEs)
percentage of participantsPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Percentage of Participants With Adverse Events (AEs)80.082.482.4

Adverse events

Collected over First dose of study drug to last dose of study drug (up to 104 weeks) + 2 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo1/125 (0.8%)20/125 (16%)66/125 (52.8%)
Sotagliflozin 200 mg0/125 (0%)10/125 (8%)67/125 (53.6%)
Sotagliflozin 400 mg0/125 (0%)9/125 (7.2%)68/125 (54.4%)
Most frequent serious events
Showing 10 of 52
Most frequent serious events
EventPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
HypoglycaemiaMetabolism and nutrition disorders2/1250/1250/125
Acute myocardial infarctionCardiac disorders1/1250/1251/125
Angina pectorisCardiac disorders0/1251/1251/125
Cardiac disorderCardiac disorders0/1251/1250/125
Cardiac failure congestiveCardiac disorders1/1250/1250/125
Coronary artery diseaseCardiac disorders1/1250/1250/125
Myocardial infarctionCardiac disorders1/1250/1250/125
Sudden hearing lossEar and labyrinth disorders1/1250/1250/125
Vertigo positionalEar and labyrinth disorders0/1251/1250/125
Food poisoningGastrointestinal disorders0/1250/1251/125
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Upper respiratory tract infectionInfections and infestations24/12515/1253/125
DiarrhoeaGastrointestinal disorders7/1256/12516/125
Urinary tract infectionInfections and infestations15/12511/12514/125
NasopharyngitisInfections and infestations12/1259/12511/125
Vitamin D deficiencyMetabolism and nutrition disorders9/12512/1257/125
InfluenzaInfections and infestations2/12511/1255/125
Bone density decreasedInvestigations5/12510/1257/125
ArthralgiaMusculoskeletal and connective tissue disorders2/1258/12510/125
FallInjury, poisoning and procedural complications9/1254/1257/125
Back painMusculoskeletal and connective tissue disorders9/1255/1255/125

Baseline characteristics

The randomized population included any participant who had been allocated to a randomized treatment regardless of whether the treatment kit was used.

Age, Continuous
Age, Continuous(years)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Mean66.3 ± 5.766.1 ± 6.766.5 ± 6.966.3 ± 6.5
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Female565655167
Male706970209
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Hispanic or Latino23212367
Not Hispanic or Latino102104102308
Unknown or Not Reported1001
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
American Indian or Alaska Native2136
Asian26252475
Native Hawaiian or Other Pacific Islander0336
Black or African American88622
White888788263
More than one race2002
Unknown or Not Reported0112
Region of Enrollment
Region of Enrollment(participants)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Austria28313
Canada20172057
South Korea89724
Mexico16141747
New Zealand991129
Russia17141950
Taiwan129728
United States424541128
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c)(percentage of HbA1c)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Mean8.38 ± 0.918.32 ± 0.968.32 ± 0.958.34 ± 0.94
Systolic Blood Pressure (SBP)
Systolic Blood Pressure (SBP)(millimeter of mercury (mmHg))PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Mean133.04 ± 13.10131.48 ± 13.69134.65 ± 14.74133.06 ± 13.88
Bone Mineral Density (BMD) T-score: Lumbar Spine
Bone Mineral Density (BMD) T-score: Lumbar Spine(t-score)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Mean0.69 ± 2.00.70 ± 1.740.88 ± 1.710.76 ± 1.82

2 further baseline measures are reported on the registry.

08

Study locations

53 sites
  • Investigational Site Number 8409009
    Escondido, California 92025, United States
  • Investigational Site Number 8409010
    Greenbrae, California 94904, United States
  • Investigational Site Number 8409005
    Walnut Creek, California 94598, United States
  • Investigational Site Number 8409012
    Columbus, Georgia 31904, United States
  • Investigational Site Number 8409011
    Evansville, Indiana 47714-8011, United States
  • Investigational Site Number 8409014
    Wichita, Kansas 67205-1138, United States
  • Investigational Site Number 8409015
    Albuquerque, New Mexico 87106, United States
  • Investigational Site Number 8409002
    Chapel Hill, North Carolina 27517, United States
  • Investigational Site Number 8409001
    Wilmington, North Carolina 28401-6638, United States
  • Investigational Site Number 8409008
    Dayton, Ohio 45419-4336, United States
  • Investigational Site Number 8409004
    Chattanooga, Tennessee 37404, United States
  • Investigational Site Number 8409013
    Austin, Texas 78749, United States
  • Investigational Site Number 8409003
    Dallas, Texas 75230, United States
  • Investigational Site Number 8409007
    Katy, Texas 77450, United States
  • Investigational Site Number 0369003
    Fremantle, 6160, Australia
  • Investigational Site Number 0369002
    Merewether, 2291, Australia
  • Investigational Site Number 0369004
    Parkville, 3050, Australia
  • Investigational Site Number 1249003
    Brampton, L6S 0C6, Canada
  • Investigational Site Number 1249008
    Etobicoke, M9R 4E1, Canada
  • Investigational Site Number 1249005
    Pointe-Claire, H9R 4S3, Canada
  • Investigational Site Number 1249006
    Thornhill, L4J 1W3, Canada
  • Investigational Site Number 1249004
    Thornhill, L4J 8L7, Canada
  • Investigational Site Number 1249007
    Vancouver, V5Y 3W2, Canada
  • Investigational Site Number 1249002
    Victoriaville, G6P 6P6, Canada
  • Investigational Site Number 4109006
    Daejeon, 35233, Korea, Republic of
  • Investigational Site Number 4109005
    Guri-Si, Gyeonggi-Do, 11923, Korea, Republic of
  • Investigational Site Number 4109003
    Gyeonggi-Do, 13620, Korea, Republic of
  • Investigational Site Number 4109004
    Seoul, 03722, Korea, Republic of
  • Investigational Site Number 4109001
    Seoul, 1830, Korea, Republic of
  • Investigational Site Number 4849006
    Aguascalientes, Aguascalientes, 20230, Mexico
  • Investigational Site Number 4849001
    Aguascalientes, 20129, Mexico
  • Investigational Site Number 4849003
    Cuernavaca, 62250, Mexico
  • Investigational Site Number 4849002
    Guadalajara Jalisco, 44130, Mexico
  • Investigational Site Number 4849004
    Monterrey, 64460, Mexico
  • Investigational Site Number 4849005
    Xalapa, 91020, Mexico
  • Investigational Site Number 5549004
    Auckland, 1309, New Zealand
  • Investigational Site Number 5549003
    Christchurch, 8011, New Zealand
  • Investigational Site Number 5549001
    Rotorua, 3010, New Zealand
  • Investigational Site Number 5549002
    Wellington, 6021, New Zealand
  • Investigational Site Number 6439007
    Kemerovo, 650002, Russian Federation
  • Investigational Site Number 6439005
    Novosibirsk, 630091, Russian Federation
  • Investigational Site Number 6439002
    Saint-Petersburg, 195213, Russian Federation
  • Investigational Site Number 6439003
    Saint-Petersburg, 196601, Russian Federation
  • Investigational Site Number 6439001
    St. Petersburg, 194358, Russian Federation
  • Investigational Site Number 6439006
    Yaroslavl, 150003, Russian Federation
  • Investigational Site Number 1589005
    Changhua, 500, Taiwan
  • Investigational Site Number 1589008
    New Taipei City, 220, Taiwan
  • Investigational Site Number 1589006
    Taichung, 402, Taiwan
  • Investigational Site Number 1589007
    Taichung, 43303, Taiwan
  • Investigational Site Number 1589001
    Tainan, 710, Taiwan
  • Investigational Site Number 1589002
    Tainan, Taiwan
  • Investigational Site Number 1589004
    Taipei, 100, Taiwan
  • Investigational Site Number 1589003
    Taipei, 11217, Taiwan
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in May 2019, 15 months.

Results were first posted in Jun 2021, 2 years 1 month after primary completion. A results delay was requested in May 2020.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2017
First posted
Dec 29, 2017
StartActual
Feb 19, 2018
Primary completionActual
May 22, 2019
CompletionActual
May 30, 2020
Results delay requested
May 1, 2020
Results first posted
Jun 25, 2021
Last update
Jun 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03386344
Lead sponsor
Lexicon Pharmaceuticals
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Dec 29, 2017
Start date
Feb 19, 2018
Primary completion
May 22, 2019
Completion
May 30, 2020
Results posted
Jun 25, 2021
Last update
Jun 25, 2021

Study contacts

Suman Wason, MD
study director · Lexicon Pharmaceuticals, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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