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CompletedNCT03285594SOTA-INSUpdated May 11, 2021Results posted

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 interventional study of Sotagliflozin and Insulin glargine (HOE901) in Type 2 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals. Completed at 106 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-11.

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

Phase
Phase 3
Study type
Interventional
Enrollment
571
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

Who can participate

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
  • 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.

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
571 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Following 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.

    Drug: Insulin glargine (HOE901) · Drug: Placebo · Drug: Oral Antidiabetes Drugs (OADs)

  • Experimental
    Sotagliflozin 200 mg

    Following 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.

    Drug: Sotagliflozin · Drug: Insulin glargine (HOE901) · Drug: Placebo · Drug: Oral Antidiabetes Drugs (OADs)

  • Experimental
    Sotagliflozin 400 mg

    Following 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.

    Drug: Sotagliflozin · Drug: Insulin glargine (HOE901) · Drug: Oral Antidiabetes Drugs (OADs)

Interventions

  • DrugSotagliflozin

    Pharmaceutical form: Tablet Route of administration: Oral

    Also known as: SAR439954

  • DrugInsulin glargine (HOE901)

    Pharmaceutical form: Solution Route of administration: Subcutaneous

    Also known as: Lantus

  • DrugPlacebo

    Pharmaceutical form: Tablet Route of administration: Oral

  • DrugOral Antidiabetes Drugs (OADs)

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

05

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline and Week 18

Secondary outcomes

  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.

    Time frame: Baseline and Week 18

  2. Change From Baseline in Body Weight at Week 18

    An ANCOVA model was used for the analysis.

    Time frame: 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.

    Time frame: Baseline and Week 12

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

    An ANCOVA model was used for the analysis.

    Time frame: Baseline to Week 12

  5. Change From Baseline in HbA1c at Week 52

    An ANCOVA model was used for the analysis.

    Time frame: Baseline and Week 52

  6. Change From Baseline in Body Weight at Week 52

    An ANCOVA model was used for the analysis.

    Time frame: 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.

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

Other outcomes

  1. Percentage of Participants With Hypoglycemic Events

    Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\] or documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\].

    Time frame: Up to 55.7 weeks

06

Results

Posted May 11, 2021

Participant flow

Participants took part in the study at 101 investigative sites in the United States, Bulgaria, Canada, Czech Republic, France, Hungary, Slovakia, the United Kingdom from 15 September 2017 to 27 September 2019.

Participant flow — Overall Study
MilestonePlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Started144141286
Treated144141285
Completed129130249
Not completed151137
Withdrew: At the participant's own request10521
Withdrew: Adverse event226
Withdrew: Poor compliance to protocol001
Withdrew: Lost to follow-up001
Withdrew: Reason not specified348

Outcome measures

PrimaryChange From Baseline in Hemoglobin A1c (HbA1c) at Week 18

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

Time frame:
Baseline and Week 18
Reported as:
Least squares mean · percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
percentage of HbA1cPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18-0.27 ± 0.073-0.72 ± 0.073-0.81 ± 0.056
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = <0.0001 · Difference in least square (ls) means: -0.45 · 95% CI -0.638 to -0.271
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = <0.0001 · Difference in ls means: -0.55 · 95% CI -0.706 to -0.387
SecondaryChange 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.

Time frame:
Baseline and Week 18
Reported as:
Least squares mean · milligram per deciliter (mg/dL)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
milligram per deciliter (mg/dL)PlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1812.882 ± 3.6045-2.975 ± 3.6083-8.949 ± 2.7550
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = 0.0006 · Difference in ls means: -15.858 · 95% CI -24.8845 to -6.8309
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = <0.0001 · Difference in ls means: -21.832 · 95% CI -29.7725 to -13.8911
SecondaryChange From Baseline in Body Weight at Week 18

An ANCOVA model was used for the analysis.

Time frame:
Baseline and Week 18
Reported as:
Least squares mean · kilogram (kg)
Change From Baseline in Body Weight at Week 18
kilogram (kg)PlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in Body Weight at Week 180.36 ± 0.249-0.73 ± 0.250-1.37 ± 0.190
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = 0.0007 · Difference in ls means: -1.09 · 95% CI -1.716 to -0.462
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = <0.0001 · Difference in ls means: -1.73 · 95% CI -2.274 to -1.183
SecondaryChange 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.

Time frame:
Baseline and Week 12
Reported as:
Least squares mean · mmHg
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12
mmHgPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg at Week 12-4.67 ± 1.470-8.58 ± 1.447-8.50 ± 1.103
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = 0.04 · Difference in ls means: -3.91 · 95% CI -7.642 to -0.178
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = 0.0239 · Difference in ls means: -3.83 · 95% CI -7.161 to -0.507
SecondaryChange From Baseline in SBP at Week 12 for All Participants

An ANCOVA model was used for the analysis.

Time frame:
Baseline to Week 12
Reported as:
Least squares mean · mmHg
Change From Baseline in SBP at Week 12 for All Participants
mmHgPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in SBP at Week 12 for All Participants-0.21 ± 1.120-5.15 ± 1.117-4.10 ± 0.867
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · Difference in ls means: -4.94 · 95% CI -7.73 to -2.142
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = 0.0018 · Difference in ls means: -3.89 · 95% CI -6.333 to -1.448
SecondaryChange From Baseline in HbA1c at Week 52

An ANCOVA model was used for the analysis.

Time frame:
Baseline and Week 52
Reported as:
Least squares mean · percentage of HbA1c
Change From Baseline in HbA1c at Week 52
percentage of HbA1cPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in HbA1c at Week 520.00 ± 0.279-0.52 ± 0.152-0.57 ± 0.114
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = 0.1265 · Difference in ls means: -0.52 · 95% CI -1.185 to 0.147
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = 0.074 · Difference in ls means: -0.57 · 95% CI -1.199 to 0.055
SecondaryChange From Baseline in Body Weight at Week 52

An ANCOVA model was used for the analysis.

Time frame:
Baseline and Week 52
Reported as:
Least squares mean · kg
Change From Baseline in Body Weight at Week 52
kgPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Change From Baseline in Body Weight at Week 52-0.18 ± 0.579-1.19 ± 0.620-0.83 ± 0.374
Statistical analysis
  • Placebo vs Sotagliflozin 200 mg · ANCOVA · p = 0.2466 · Difference in ls means: -1.01 · 95% CI -2.707 to 0.696
  • Placebo vs Sotagliflozin 400 mg · ANCOVA · p = 0.332 · Difference in ls means: -0.65 · 95% CI -1.969 to 0.665
SecondaryPercentage 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.

Time frame:
First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 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)64.654.659.3
Other pre-specifiedPercentage of Participants With Hypoglycemic Events

Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\] or documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL\].

Time frame:
Up to 55.7 weeks
Reported as:
Number · percentage of participants
Percentage of Participants With Hypoglycemic Events
percentage of participantsPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Any hypoglycemia62.556.062.8
Documented symptomatic hypoglycemia44.441.846
Severe or documented symptomatic hypoglycemia44.441.846

Adverse events

Collected over Deaths: Up to approximately 60 weeks; Adverse Events: First dose of study drug to last dose of study drug (up to 55.7 weeks) + 2 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo2/144 (1.4%)16/144 (11.1%)30/144 (20.8%)
Sotagliflozin 200 mg1/141 (0.7%)19/141 (13.5%)18/141 (12.8%)
Sotagliflozin 400 mg6/285 (2.1%)28/285 (9.8%)45/285 (15.8%)
Most frequent serious events
Showing 10 of 76
Most frequent serious events
EventPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
Atrial fibrillationCardiac disorders3/1440/1410/285
Back painMusculoskeletal and connective tissue disorders0/1442/1410/285
Acute myocardial infarctionCardiac disorders2/1440/1412/285
Peripheral arterial occlusive diseaseVascular disorders0/1441/1410/285
Adenocarcinoma pancreasNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1441/1410/285
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1441/1410/285
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1441/1410/285
Postoperative thrombosisInjury, poisoning and procedural complications0/1441/1410/285
Angina unstableCardiac disorders1/1441/1410/285
Atrial flutterCardiac disorders0/1441/1410/285
Most frequent other events
Most frequent other events
EventPlaceboSotagliflozin 200 mgSotagliflozin 400 mg
NasopharyngitisInfections and infestations7/1449/14114/285
Vitamin D deficiencyMetabolism and nutrition disorders9/1444/14110/285
Upper respiratory tract infectionInfections and infestations8/1441/14114/285
Urinary tract infectionInfections and infestations8/1446/14111/285

Baseline characteristics

Intent-to-treat (ITT) population included all randomized participants irrespective of compliance with the study protocol and procedures.

Age, Continuous
Age, Continuous(years)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Mean62.2 ± 8.962.1 ± 10.262.7 ± 9.162.4 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Female5865132255
Male8676154316
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Hispanic or Latino12254279
Not Hispanic or Latino129113239481
Unknown or Not Reported33511
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
American Indian or Alaska Native2125
Asian91616
Native Hawaiian or Other Pacific Islander0033
Black or African American10102747
White117124234475
More than one race1012
Unknown or Not Reported551323
Region of Enrollment
Region of Enrollment(participants)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Bulgaria9133557
Canada761629
Czechia14112449
France881430
Hungary12132146
Slovakia24213277
United Kingdom0044
United States7069140279
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c)(percentage of HbA1c)PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Mean8.76 ± 0.798.76 ± 0.838.69 ± 0.808.72 ± 0.80
Systolic Blood Pressure (SBP)
Systolic Blood Pressure (SBP)(millimeter of Mercury (mmHg))PlaceboSotagliflozin 200 mgSotagliflozin 400 mgTotal
Mean137.59 ± 14.12136.40 ± 15.54135.84 ± 14.95136.42 ± 14.89
07

Study locations

106 sites
  • Investigational Site Number 8406028
    Mesa, Arizona 85213-5226, United States
  • Investigational Site Number 8406013
    Phoenix, Arizona 85018, United States
  • Investigational Site Number 8406020
    Phoenix, Arizona 85020, United States
  • Investigational Site Number 8406006
    Huntington Park, California 90255, United States
  • Investigational Site Number 8406053
    Lincoln, California 95648, United States
  • Investigational Site Number 8406040
    Los Angeles, California 90057, United States
  • Investigational Site Number 8406043
    Coral Gables, Florida 33134, United States
  • Investigational Site Number 8406008
    DeLand, Florida 32720, United States
  • Investigational Site Number 8406030
    Maitland, Florida 32751, United States
  • Investigational Site Number 8406003
    New Port Richey, Florida 34652, United States
  • Investigational Site Number 8406029
    North Miami Beach, Florida 33162, United States
  • Investigational Site Number 8406052
    Ocoee, Florida 34761, United States
  • Investigational Site Number 8406001
    Port Charlotte, Florida 33952, United States
  • Investigational Site Number 8406022
    Saint Petersburg, Florida 33700, United States
  • Investigational Site Number 8406025
    Tampa, Florida 33634, United States
  • Investigational Site Number 8406002
    West Palm Beach, Florida 33401-3430, United States
  • Investigational Site Number 8406054
    Chicago, Illinois 60602, United States
  • Investigational Site Number 8406027
    Chicago, Illinois 60604, United States
  • Investigational Site Number 8406042
    Evansville, Indiana 47714, United States
  • Investigational Site Number 8406044
    New Orleans, Louisiana 70119-6302, United States
  • Investigational Site Number 8406051
    New Orleans, Louisiana 70124, United States
  • Investigational Site Number 8406024
    Rockville, Maryland 20852, United States
  • Investigational Site Number 8406016
    Detroit, Michigan 48202, United States
  • Investigational Site Number 8406011
    Saint Louis, Missouri 63110, United States
  • Investigational Site Number 8406010
    Papillion, Nebraska 68046-3136, United States
  • Investigational Site Number 8406018
    New York, New York 10016-6023, United States
  • Investigational Site Number 8406034
    Asheville, North Carolina 28803, United States
  • Investigational Site Number 8406046
    Chapel Hill, North Carolina 27517, United States
  • Investigational Site Number 8406026
    Charlotte, North Carolina 28209, United States
  • Investigational Site Number 8406038
    Greenville, North Carolina 27834, United States
  • Investigational Site Number 8406036
    Hickory, North Carolina 28601, United States
  • Investigational Site Number 8406015
    Wilmington, North Carolina 28401-6638, United States
  • Investigational Site Number 8406019
    Winston-Salem, North Carolina 27103, United States
  • Investigational Site Number 8406031
    Beachwood, Ohio 44122, United States
  • Investigational Site Number 8406023
    Columbus, Ohio 43201, United States
  • Investigational Site Number 8406005
    Dublin, Ohio 43016, United States
  • Investigational Site Number 8406004
    Mentor, Ohio 44060, United States
  • Investigational Site Number 8406033
    Oklahoma City, Oklahoma 73111, United States
  • Investigational Site Number 8406032
    Moncks Corner, South Carolina 29461-5017, United States
  • Investigational Site Number 8406009
    Chattanooga, Tennessee 37421, United States
  • Investigational Site Number 8406045
    Seymour, Tennessee 37865-5270, United States
  • Investigational Site Number 8406047
    Dallas, Texas 75230, United States
  • Investigational Site Number 8406017
    Dallas, Texas 75231, United States
  • Investigational Site Number 8406048
    Houston, Texas 77079, United States
  • Investigational Site Number 8406037
    Houston, Texas 77099, United States
  • Investigational Site Number 8406039
    McAllen, Texas 78504, United States
  • Investigational Site Number 8406050
    San Antonio, Texas 78229, United States
  • Investigational Site Number 8406021
    Shavano Park, Texas 78231, United States
  • Investigational Site Number 8406035
    Salt Lake City, Utah 84102-1553, United States
  • Investigational Site Number 8406014
    West Jordan, Utah 84088-8865, United States
  • Investigational Site Number 1006009
    Gabrovo, 5300, Bulgaria
  • Investigational Site Number 1006003
    Plovdiv, 4002, Bulgaria
  • Investigational Site Number 1006004
    Ruse, 7002, Bulgaria
  • Investigational Site Number 1006001
    Ruse, 7003, Bulgaria
  • Investigational Site Number 1006006
    Smolyan, 4700, Bulgaria
  • Investigational Site Number 1006002
    Sofia, 1606, Bulgaria
  • Investigational Site Number 1006010
    Sofia, 1750, Bulgaria
  • Investigational Site Number 1006005
    Stara Zagora, 6000, Bulgaria
  • Investigational Site Number 1006007
    Varna, 9000, Bulgaria
  • Investigational Site Number 1246003
    Brampton, L6S 0C9, Canada
  • Investigational Site Number 1246005
    Burlington, L7R 1E2, Canada
  • Investigational Site Number 1246004
    Etobicoke, M9R 4E1, Canada
  • Investigational Site Number 1246002
    Toronto, M4G 3E8, Canada
  • Investigational Site Number 1246001
    Vancouver, V5Y 3W2, Canada
  • Investigational Site Number 2036003
    Holesov, 769 01, Czechia
  • Investigational Site Number 2036002
    Krnov, 794 01, Czechia
  • Investigational Site Number 2036001
    Olomouc, 779 00, Czechia
  • Investigational Site Number 2036005
    Ostrava, 702 00, Czechia
  • Investigational Site Number 2036006
    Praha 10 - Uhrineves, 104 00, Czechia
  • Investigational Site Number 2036007
    Praha 4, 140 46, Czechia
  • Investigational Site Number 2036008
    Praha 4, 149 00, Czechia
  • Investigational Site Number 2506008
    Besançon Cedex, 25030, France
  • Investigational Site Number 2506003
    Corbeil-Essonnes, 91106, France
  • Investigational Site Number 2506005
    Dijon, 21079, France
  • Investigational Site Number 2506012
    Mulhouse, 68100, France
  • Investigational Site Number 2506004
    Nantes, 44093, France
  • Investigational Site Number 2506007
    Narbonne, 11100, France
  • Investigational Site Number 2506006
    Paris, 75018, France
  • Investigational Site Number 2506010
    Pierre-Benite, 69495, France
  • Investigational Site Number 2506009
    Poitiers, 86021, France
  • Investigational Site Number 2506011
    Saint-Mande, 94160, France
  • Investigational Site Number 2506002
    Vénissieux, 69200, France
  • Investigational Site Number 3486007
    Budapest, 1106, Hungary
  • Investigational Site Number 3486002
    Budapest, 1134, Hungary
  • Investigational Site Number 3486006
    Hatvan, 3000, Hungary
  • Investigational Site Number 3486009
    Kecskemet, 6000, Hungary
  • Investigational Site Number 3486003
    Komarom, 2900, Hungary
  • Investigational Site Number 3486005
    Nyíregyháza, 4400, Hungary
  • Investigational Site Number 3486001
    Pécs, 7623, Hungary
  • Investigational Site Number 3486008
    Zalaegerszeg, 8900, Hungary
  • Investigational Site Number 7036004
    Bardejov, 085 01, Slovakia
  • Investigational Site Number 7036008
    Bratislava, 831 06, Slovakia
  • Investigational Site Number 7036001
    Bratislava, 85101, Slovakia
  • Investigational Site Number 7036010
    Kosice, 040 01, Slovakia
  • Investigational Site Number 7036003
    Kosice, 4014, Slovakia
  • Investigational Site Number 7036007
    Levice, 934 01, Slovakia
  • Investigational Site Number 7036009
    Levice, 934 05, Slovakia
  • Investigational Site Number 7036011
    Lucenec, 98401, Slovakia
  • Investigational Site Number 7036006
    Nitra, 949 11, Slovakia
  • Investigational Site Number 7036005
    Sabinov, 08301, Slovakia

Showing the first 100 of 106 sites across 8 countries.

08

References and documents

Study documents

  • Study protocol · Mar 12, 2018
  • Statistical analysis plan · Dec 5, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03285594
Lead sponsor
Lexicon Pharmaceuticals
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Sep 15, 2017
Primary completion
Sep 17, 2019
Completion
Sep 27, 2019
Results posted
May 11, 2021
Last update
May 11, 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 ↗

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

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