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CompletedNCT03259789Updated Jul 7, 2021Results posted

Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

A Phase 3 interventional study of Bexagliflozin tablets, 20 mg and Bexagliflozin tablets, placebo in Type2 Diabetes Mellitus, sponsored by Theracos. Completed at 43 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-07-07.

Sponsored by Theracos · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
351
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the effect of bexagliflozin compared to placebo as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

Read the detailed description

Approximately 300 subjects with inadequately controlled T2DM on metformin were to be recruited from the United States and Japan. Subjects were randomly assigned to receive bexagliflozin tablets, 20 mg, or bexagliflozin tablets, placebo, in a ratio of 1:1 once daily for 24 weeks. Subjects were to continue taking metformin for the duration of the study. The study also enrolled 50 subjects with extremely poorly controlled T2DM on metformin to receive open-label bexagliflozin tablets, 20 mg, for 24 weeks.

02

Conditions studied

  • Type2 Diabetes Mellitus
03

Who can participate

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

Eligibility criteria

The subjects were required to meet the following criteria at the time of enrollment to be eligible for the study:

  1. Had been age ≥ 20 years at screening. Women of childbearing potential were required to have tested negative for pregnancy and have agreed to abstinence or contraception for the duration of the study to avoid any possible pregnancy. Females who were surgically sterile (hysterectomy, oophorectomy) or postmenopausal (absence of menses greater than 12 months) were eligible if they had tested negative for pregnancy at screening.
  2. a) Had a history of T2DM with an HbA1c level of ≥ 7.5% and ≤ 10.5% at screening, or b) Had a history of T2DM with an HbA1c level of >10.5% and ≤ 12.0% at screening
  3. Had been prescribed a stable dose of metformin (≥1500 mg per day in the US or ≥ 1000 mg per day in Japan) as their sole anti-diabetic medication
  4. Had a body mass index (BMI) ≤ 45 kg m-2
  5. Had been able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines
  6. Had no recent changes to their medications for hypertension or hyperlipidemia (if applicable)
  7. Had the ability to regularly self-administer medication, as evidenced by consumption of all, or at worst one less than all, doses of run-in medication prior to randomization

Subjects who met any of the following criteria were to be excluded from the study:

  1. Had a diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
  2. Were pregnant or breastfeeding
  3. Had one or more hemoglobin alleles that affect HbA1c measurement
  4. Had a history of genitourinary tract infection (e.g., UTI, GMI, vaginitis, balanitis) within 6 weeks of screening or a history of ≥ 3 genitourinary infections requiring treatment within 6 months of screening
  5. Had an estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), \< 60 mL min-1 per 1.73 m2
  6. Had a sitting systolic blood pressure >180 mmHg or a sitting diastolic blood pressure > 110 mmHg at screening
  7. Had exposure to hypoglycemic agent(s) other than metformin during the 8 weeks prior to screening
  8. Had a history of illicit drug use or alcohol abuse in the past 2 years
  9. Had a life expectancy \< 2 years
  10. Had a diagnosis of New York Heart Association (NYHA) Class IV heart failure within 3 months of screening
  11. Had experienced an MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
  12. Had exposure to an investigational drug within 30 days
  13. Had a previous exposure to bexagliflozin or EGT0001474
  14. Had a history of SGLT2 inhibitor treatment
  15. Were participating in another interventional trial
  16. Were not able to comply with the study scheduled visits
  17. Had any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the primary investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment
  18. Had an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × ULN or total bilirubin ≥ 1.5 × ULN at screening
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
351 participants (actual)

Study arms

  • Active comparator
    Bexagliflozin tablets, 20 mg; Double-Blind

    Drug: Bexagliflozin tablets, 20 mg

  • Placebo comparator
    Bexagliflozin tablets, Placebo; Double Blind

    Drug: Bexagliflozin tablets, placebo

  • Experimental
    Bexagliflozin Tablets, 20 mg; High Glycemic Group

    Drug: Bexagliflozin tablets, 20 mg

Interventions

  • DrugBexagliflozin tablets, 20 mg

    Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.

    Also known as: EGT0001442, EGT0001474

  • DrugBexagliflozin tablets, placebo

    Each subject will receive placebo (inactive tablet) once daily for the duration of the study.

  • DrugBexagliflozin tablets, 20 mg

    Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.

    Also known as: EGT0001442, EGT0001474

05

What researchers measure

Primary outcomes

  1. Change From Baseline in HbA1c at Week 24 for Double-blind Group

    HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.

    Time frame: Baseline to week 24

  2. Change From Baseline in HbA1c at Week 24 for High Glycemic Group

    The change in HbA1c from baseline at Week 24 in High Glycemic Group was calculated by subtracting the mean HbA1c at baseline from the mean HbA1c at Week 24

    Time frame: Baseline to week 24

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group

    FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.

    Time frame: Baseline, up to 24 weeks

  2. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group

    The change in FPG from baseline at Week 24 for High Glycemic Group was calculated by subtracting the mean FPG at baseline from the mean FPG at Week 24

    Time frame: Baseline, up to 24 weeks

  3. Change From Baseline in Systolic Blood Pressure (SBP) at Week 24

    Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group

    Time frame: Baseline to week 24

  4. Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group

    The proportion of subjects who achieved HbA1c \< 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group. The model-adjusted proportion was calculated based on a logistic analysis using Generalized Estimating Equation (GEE) logistic regression that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate. An unstructured correlation structure will be used, or autoregressive if the model with the unstructured structure does not converge.

    Time frame: Baseline, up to 24 weeks

  5. Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group

    The proportion of subjects who achieved HbA1c \< 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group.

    Time frame: Baseline, up to 24 weeks

  6. Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group

    Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups.

    Time frame: Baseline to week 24

  7. Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group

    The change in body mass from baseline at week 24 for High Glycemic group was calculated by subtracting the mean body mass at baseline from the mean body mass at week 24

    Time frame: Baseline to week 24

  8. Change From Baseline in HbA1c Over Time in Double-blind Treatment Group

    The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point for each group. The model-adjusted change from baseline was calculated based on a mixed-effects repeated measures analysis that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.

    Time frame: Baseline, up to 24 weeks

  9. Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0%

    The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point in High Glycemic Group.

    Time frame: Baseline, up to 24 weeks

06

Results

Posted Jul 7, 2021

Participant flow

Participant flow — Overall Study
MilestoneDouble-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic Group
Started15815934
Completed14114228
Not completed17176
Withdrew: Adverse event321
Withdrew: Withdrawal by subject951
Withdrew: Lost to follow-up594
Withdrew: Physician decision010

Outcome measures

PrimaryChange From Baseline in HbA1c at Week 24 for Double-blind Group

HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.

Time frame:
Baseline to week 24
Reported as:
Least squares mean · percentage of HbA1c
Change From Baseline in HbA1c at Week 24 for Double-blind Group
percentage of HbA1cDouble-blind Group: Bexagliflozin 20 mgDouble-blind Group: Placebo
Change From Baseline in HbA1c at Week 24 for Double-blind Group-1.09 ± 0.076-0.56 ± 0.075
Statistical analysis
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = < 0.0001 · Difference of ls means: -0.53 · 95% CI -0.74 to -0.32Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates
PrimaryChange From Baseline in HbA1c at Week 24 for High Glycemic Group

The change in HbA1c from baseline at Week 24 in High Glycemic Group was calculated by subtracting the mean HbA1c at baseline from the mean HbA1c at Week 24

Time frame:
Baseline to week 24
Reported as:
Mean · percentage of HbA1c
Change From Baseline in HbA1c at Week 24 for High Glycemic Group
percentage of HbA1cHigh Glycemic Group
Change From Baseline in HbA1c at Week 24 for High Glycemic Group-2.82 ± 1.084
SecondaryChange From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group

FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.

Time frame:
Baseline, up to 24 weeks
Reported as:
Least squares mean · mmol/L
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group
mmol/LDouble-blind Group: Bexagliflozin 20 mgDouble-blind Group: Placebo
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group-2.51 ± 0.174-1.16 ± 0.173
Statistical analysis
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = < 0.0001 · Difference of ls means: -1.35 · 95% CI -1.83 to -0.86Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates
SecondaryChange From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group

The change in FPG from baseline at Week 24 for High Glycemic Group was calculated by subtracting the mean FPG at baseline from the mean FPG at Week 24

Time frame:
Baseline, up to 24 weeks
Reported as:
Mean · mmol/L
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group
mmol/LHigh Glycemic Group
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group-4.98 ± 3.437
SecondaryChange From Baseline in Systolic Blood Pressure (SBP) at Week 24

Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group

Time frame:
Baseline to week 24
Reported as:
Least squares mean · mm Hg
Change From Baseline in Systolic Blood Pressure (SBP) at Week 24
mm HgDouble-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic Group
Change From Baseline in Systolic Blood Pressure (SBP) at Week 24-5.03 ± 0.9932.04 ± 0.987-8.19 ± 14.882
Statistical analysis
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = < 0.0001 · Difference of ls means: -7.07 · 95% CI -9.83 to -4.32Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates
SecondaryProportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group

The proportion of subjects who achieved HbA1c \< 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group. The model-adjusted proportion was calculated based on a logistic analysis using Generalized Estimating Equation (GEE) logistic regression that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate. An unstructured correlation structure will be used, or autoregressive if the model with the unstructured structure does not converge.

Time frame:
Baseline, up to 24 weeks
Reported as:
Least squares mean · Proportion of subjects
Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group
Proportion of subjectsDouble-blind Group: Bexagliflozin 20 mgDouble-blind Group: Placebo
Week 60.14 (0.09 to 0.23)0.03 (0.01 to 0.07)
Week 120.26 (0.18 to 0.38)0.06 (0.03 to 0.12)
Week 180.26 (0.18 to 0.39)0.10 (0.06 to 0.18)
Week 240.38 (0.26 to 0.55)0.10 (0.06 to 0.17)
Statistical analysis
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = 0.0014 (P-value is presented based on one-sided statistical tests using a 0.025 level of significance) · Odds ratio (or): 4.69 · 95% CI 1.70 to 12.95The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = 0.0001 (P-value is presented based on one-sided statistical tests using a 0.025 level of significance) · Odds ratio (or): 4.18 · 95% CI 1.96 to 8.92The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = 0.0030 (P-value is presented based on one-sided statistical tests using a 0.025 level of significance) · Odds ratio (or): 2.57 · 95% CI 1.31 to 5.04The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = < 0.0001 (P-value is presented based on one-sided statistical tests using a 0.025 level of significance) · Odds ratio (or): 3.88 · 95% CI 1.99 to 7.58The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.
SecondaryProportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group

The proportion of subjects who achieved HbA1c \< 7% at 6, 12, 18 and 24 weeks were calculated based on the number of subjects with a value at each time point for each group.

Time frame:
Baseline, up to 24 weeks
Reported as:
Number · Proportion of subjects
Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group
Proportion of subjectsHigh Glycemic Group
Week 60
Week 120.065
Week 180.097
Week 240.138
SecondaryChange in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group

Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups.

Time frame:
Baseline to week 24
Reported as:
Least squares mean · kg
Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group
kgDouble-blind Group: Bexagliflozin 20 mgDouble-blind Group: Placebo
Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group-3.60 ± 0.348-1.09 ± 0.336
Statistical analysis
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · ANCOVA · p = < 0.0001 · Difference of ls means: -2.51 · 95% CI -3.45 to -1.57ANCOVA analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates
SecondaryChange in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group

The change in body mass from baseline at week 24 for High Glycemic group was calculated by subtracting the mean body mass at baseline from the mean body mass at week 24

Time frame:
Baseline to week 24
Reported as:
Mean · kg
Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group
kgHigh Glycemic Group
Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group-1.40 ± 3.759
SecondaryChange From Baseline in HbA1c Over Time in Double-blind Treatment Group

The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point for each group. The model-adjusted change from baseline was calculated based on a mixed-effects repeated measures analysis that includes country, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.

Time frame:
Baseline, up to 24 weeks
Reported as:
Least squares mean · percentage of HbA1c
Change From Baseline in HbA1c Over Time in Double-blind Treatment Group
percentage of HbA1cDouble-blind Group: Bexagliflozin 20 mgDouble-blind Group: Placebo
Week 6-0.72 ± 0.065-0.16 ± 0.065
Week 12-0.97 ± 0.073-0.31 ± 0.073
Week 18-1.00 ± 0.072-0.51 ± 0.072
Week 24-1.09 ± 0.076-0.56 ± 0.075
Statistical analysis
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = < 0.0001 (P-value is presented based on one-sided statistical tests using a 0.025 level of significance) · Difference of ls means: -0.56 · 95% CI -0.74 to -0.38Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = < 0.0001 (P-value is presented based on one-sided statistical tests using a 0.025 level of significance) · Difference of ls means: -0.66 · 95% CI -0.86 to -0.46Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = < 0.0001 (P-value is presented based on one-sided statistical tests using a 0.025 level of significance) · Difference of ls means: -0.50 · 95% CI -0.69 to -0.30Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates
  • Double-blind Group: Bexagliflozin 20 mg vs Double-blind Group: Placebo · Mixed-effects repeated measures · p = < 0.0001 (P-value is presented based on one-sided statistical tests using a 0.025 level of significance) · Difference of ls means: -0.53 · 95% CI -0.74 to -0.32Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates
SecondaryChange in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0%

The change from baseline in HbA1c at 6, 12, 18 and 24 weeks was calculated based on the number of subjects with a value at each time point in High Glycemic Group.

Time frame:
Baseline, up to 24 weeks
Reported as:
Mean · percentage of HbA1c
Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0%
percentage of HbA1cHigh Glycemic Group
Week 6-1.72 ± 1.027
Week 12-2.45 ± 1.136
Week 18-2.62 ± 1.055
Week 24-2.82 ± 1.084

Adverse events

Collected over Adverse events were collected from Week -1 (run in period: Visit 2) to Week 26 (Follow up: Visit 8).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Double-blind Group: Bexagliflozin 20 mg0/158 (0%)3/158 (1.9%)16/158 (10.1%)
Double-blind Group: Placebo0/159 (0%)4/159 (2.5%)28/159 (17.6%)
High Glycemic Group0/34 (0%)0/34 (0%)7/34 (20.6%)
Most frequent serious events
Most frequent serious events
EventDouble-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic Group
Acute coronary syndromeCardiac disorders1/1580/1590/34
Diabetic ketoacidosisMetabolism and nutrition disorders1/1580/1590/34
Acute cardiac failureCardiac disorders1/1580/1590/34
Atrial fibrillationCardiac disorders0/1581/1590/34
ConstipationGastrointestinal disorders0/1581/1590/34
AsthmaRespiratory, thoracic and mediastinal disorders0/1581/1590/34
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/1581/1590/34
HypertensionVascular disorders0/1581/1590/34
Most frequent other events
Most frequent other events
EventDouble-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic Group
PolyuriaRenal and urinary disorders5/1586/1594/34
PolydipsiaMetabolism and nutrition disorders5/1584/1593/34
NasopharyngitisInfections and infestations9/15813/1591/34
Diabetes mellitus inadequate controlMetabolism and nutrition disorders3/15810/1591/34
Glomerular filtration rate decreasedInvestigations0/1580/1592/34

Baseline characteristics

Age, Continuous
Age, Continuous(years)Double-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic GroupTotal
Double-blind Group56.0 ± 10.0555.6 ± 11.18—55.8 ± 10.62
High Glycemic Group——52.1 ± 8.5952.1 ± 8.59
Sex: Female, Male
Sex: Female, Male(Participants)Double-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic GroupTotal
Female586515138
Male1009419213
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Double-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic GroupTotal
Hispanic or Latino3532976
Not Hispanic or Latino12312725275
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Double-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic GroupTotal
American Indian or Alaska Native1113
Asian78799166
Native Hawaiian or Other Pacific Islander1012
Black or African American26291267
White514811110
More than one race1203
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Double-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic GroupTotal
United States838327193
Japan75767158
Height
Height(cm)Double-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic GroupTotal
Double-blind Group168.4 ± 9.71167.3 ± 9.55—167.8 ± 9.63
High Glycemic Group——169.4 ± 9.34169.4 ± 9.34
Body Weight
Body Weight(kg)Double-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic GroupTotal
Double-blind Group84.58 ± 21.98984.44 ± 20.928—84.51 ± 21.43
High Glycemic Group——87.28 ± 17.75987.28 ± 17.759
BMI
BMI(kg/m^2)Double-blind Group: Bexagliflozin 20 mgDouble-blind Group: PlaceboHigh Glycemic GroupTotal
Double-blind Group29.67 ± 6.4529.99 ± 6.342—29.83 ± 6.388
High Glycemic Group——30.37 ± 5.55830.37 ± 5.558
07

Study locations

43 sites
  • Clinical Research Site 1232
    Birmingham, Alabama 35205, United States
  • Clinical Research Site 1378
    Birmingham, Alabama 35242, United States
  • Clinical Research Site 1269
    Foley, Alabama 36535, United States
  • Clinical Research Site 1363
    Little Rock, Arkansas 72209, United States
  • Clinical Research Site 1381
    Anaheim, California 92805, United States
  • Clinical Research Site 1375
    North Hollywood, California 91606, United States
  • Clinical Research Site 1365
    Norwalk, California 90650, United States
  • Clinical Research Site 1382
    Norwalk, Connecticut 06851, United States
  • Clinical Research Site 1372
    Hollywood, Florida 33024, United States
  • Clinical Research Site 1362
    Palm Springs, Florida 33461, United States
  • Clinical Research Site 1373
    Pembroke Pines, Florida 33026, United States
  • Clinical Research Site 1376
    Nampa, Idaho 83686, United States
  • Clinical Research Site 1366
    Chicago, Illinois 60602, United States
  • Clinical Research Site 1294
    New Orleans, Louisiana 70124, United States
  • Clinical Research Site 1374
    Saint Louis, Missouri 63117, United States
  • Clinical Research Site 1370
    Las Vegas, Nevada 89104, United States
  • Clinical Research Site 1009
    Berlin, New Jersey 08009, United States
  • Clinical Research Site 1037
    Trenton, New Jersey 08611, United States
  • Clinical Research Site 1286
    Albuquerque, New Mexico 87102, United States
  • Clinical Research Site 1275
    Bronx, New York 10455, United States
  • Clinical Research Site 1368
    New York, New York 10036, United States
  • Clinical Research Site 1019
    Portland, Oregon 97239, United States
  • Clinical Research Site 1379
    Gonzales, Texas 78629, United States
  • Clinical Research Site 1369
    Houston, Texas 77051, United States
  • Clinical Research Site 1371
    San Antonio, Texas 78209, United States
  • Clinical Research Site 1360
    San Antonio, Texas 78258, United States
  • Clinical Research Site 6048
    Nagoya, Aichi 456-0058, Japan
  • Clinical Research Site 6050
    Sapporo, Hokkaido 003-0023, Japan
  • Clinical Research Site 6041
    Koga, Ibaraki 306-0232, Japan
  • Clinical Research Site 6029
    Atsugi, Kanagawa 243-0035, Japan
  • Clinical Research Site 6051
    Kamakura, Kanagawa 547-0055, Japan
  • Clinical Research Site 6020
    Yokohama, Kanagawa 221-080, Japan
  • Clinical Research Site 6055
    Tokyo, Meguro 153-0053, Japan
  • Clinical Research Site 6046
    Higashiosaka, Osaka 577-0803, Japan
  • Clinical Research Site 6033
    Kashiwara, Osaka 582-0005, Japan
  • Clinical Research Site 6013
    Toyonaka, Osaka 560-0082, Japan
  • Clinical Research Site 6052
    Kawaguchi, Saitama 332-0012, Japan
  • Clinical Research Site 6053
    Shimotsuke, Tochigi 329-0433, Japan
  • Clinical Research Site 6040
    Fukuoka, 819-0006, Japan
  • Clinical Research Site 6043
    Kyoto, 600-8898, Japan
  • Clinical Research Site 6015
    Osaka, 536-0008, Japan
  • Clinical Research Site 6045
    Tokyo, 108-0075, Japan
  • Clinical Research Site 6047
    Tokyo, 166-0003, Japan
08

References and documents

Study documents

  • Study protocol · Jul 26, 2017
  • Statistical analysis plan · Feb 15, 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
NCT03259789
Lead sponsor
Theracos
Responsible party
Sponsor
First posted
Aug 24, 2017
Start date
Nov 28, 2017
Primary completion
Jan 23, 2019
Completion
Jan 23, 2019
Results posted
Jul 7, 2021
Last update
Jul 7, 2021

Study contacts

J, Paul Lock, M.D.
study director · Theracos

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 Jul 2021. You cannot join it, but the record below documents what was studied.

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