Type2 Diabetes Mellitus
Conditions
Brief 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).
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.
Interventions
DRUGBexagliflozin tablets, 20 mg
Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.
Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
Sponsors
Theracos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c at Week 24 for Double-blind Group | Baseline to week 24 | HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis. |
| Change From Baseline in HbA1c at Week 24 for High Glycemic Group | Baseline to week 24 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 24 | Baseline to week 24 | Changes from baseline at Week 24 in SBP for the double-blind group and high glycemic group |
| Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group | Baseline, up to 24 weeks | 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. |
| Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group | Baseline, up to 24 weeks | 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. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group | Baseline, up to 24 weeks | FPG was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis. |
| Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group | Baseline to week 24 | 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 |
| Change From Baseline in HbA1c Over Time in Double-blind Treatment Group | Baseline, up to 24 weeks | 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. |
| Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0% | Baseline, up to 24 weeks | 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. |
| Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group | Baseline to week 24 | Changes in body mass from baseline to week 24 was calculated based on LS means for both bexagliflozin and placebo groups. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group | Baseline, up to 24 weeks | 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 |
Countries
Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Double-blind Group: Bexagliflozin 20 mg Each subject will receive bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency. | 158 |
| Double-blind Group: Placebo Each subject will receive placebo (inactive tablet) once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency. | 159 |
| High Glycemic Group Each subject will receive Bexagliflozin, 20 mg, once daily and open-labeled metformin background medication during the entire study at a stable dose and frequency. | 34 |
| Total | 351 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 | 1 |
| Overall Study | Lost to Follow-up | 5 | 9 | 4 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 5 | 1 |
Baseline characteristics
| Characteristic | Double-blind Group: Placebo | Total | Double-blind Group: Bexagliflozin 20 mg | High Glycemic Group |
|---|---|---|---|---|
| Age, Continuous Double-blind Group | 55.6 years STANDARD_DEVIATION 11.18 | 55.8 years STANDARD_DEVIATION 10.62 | 56.0 years STANDARD_DEVIATION 10.05 | — |
| Age, Continuous High Glycemic Group | — | 52.1 years STANDARD_DEVIATION 8.59 | — | 52.1 years STANDARD_DEVIATION 8.59 |
| BMI Double-blind Group | 29.99 kg/m^2 STANDARD_DEVIATION 6.342 | 29.83 kg/m^2 STANDARD_DEVIATION 6.388 | 29.67 kg/m^2 STANDARD_DEVIATION 6.45 | — |
| BMI High Glycemic Group | — | 30.37 kg/m^2 STANDARD_DEVIATION 5.558 | — | 30.37 kg/m^2 STANDARD_DEVIATION 5.558 |
| Body Weight Double-blind Group | 84.44 kg STANDARD_DEVIATION 20.928 | 84.51 kg STANDARD_DEVIATION 21.43 | 84.58 kg STANDARD_DEVIATION 21.989 | — |
| Body Weight High Glycemic Group | — | 87.28 kg STANDARD_DEVIATION 17.759 | — | 87.28 kg STANDARD_DEVIATION 17.759 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 76 Participants | 35 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants | 275 Participants | 123 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height Double-blind Group | 167.3 cm STANDARD_DEVIATION 9.55 | 167.8 cm STANDARD_DEVIATION 9.63 | 168.4 cm STANDARD_DEVIATION 9.71 | — |
| Height High Glycemic Group | — | 169.4 cm STANDARD_DEVIATION 9.34 | — | 169.4 cm STANDARD_DEVIATION 9.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 79 Participants | 166 Participants | 78 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 67 Participants | 26 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 110 Participants | 51 Participants | 11 Participants |
| Region of Enrollment Japan | 76 participants | 158 participants | 75 participants | 7 participants |
| Region of Enrollment United States | 83 participants | 193 participants | 83 participants | 27 participants |
| Sex: Female, Male Female | 65 Participants | 138 Participants | 58 Participants | 15 Participants |
| Sex: Female, Male Male | 94 Participants | 213 Participants | 100 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 158 | 0 / 159 | 0 / 34 |
| other Total, other adverse events | 16 / 158 | 28 / 159 | 7 / 34 |
| serious Total, serious adverse events | 3 / 158 | 4 / 159 | 0 / 34 |
Outcome results
Primary
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
Population: The intention-to-treat (ITT) population was used for the primary analysis. Subjects with a value at baseline and at week 24 were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Change From Baseline in HbA1c at Week 24 for Double-blind Group | -1.09 percentage of HbA1c | Standard Error 0.076 |
| Double-blind Group: Placebo | Change From Baseline in HbA1c at Week 24 for Double-blind Group | -0.56 percentage of HbA1c | Standard Error 0.075 |
p-value: <0.000195% CI: [-0.74, -0.32]Mixed-effects repeated measures
Primary
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
Population: The intention-to-treat (ITT) population was used for the primary analysis. Subjects with a value at baseline and at week 24 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Change From Baseline in HbA1c at Week 24 for High Glycemic Group | -2.82 percentage of HbA1c | Standard Deviation 1.084 |
Secondary
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
Population: ITT population was used for the analysis. Subjects with a value at baseline and at week 24 were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group | -2.51 mmol/L | Standard Error 0.174 |
| Double-blind Group: Placebo | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group | -1.16 mmol/L | Standard Error 0.173 |
p-value: <0.000195% CI: [-1.83, -0.86]Mixed-effects repeated measures
Secondary
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
Population: ITT population was used for the analysis. Subjects with a value at baseline and at week 24 were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group | -4.98 mmol/L | Standard Deviation 3.437 |
Secondary
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
Population: The Number Analyzed only includes the number of subjects with a value at baseline and at the specific visit. Model-adjusted mean change (LS Mean) and standard error (SE) were reported for Double-blind Treatment Group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Change From Baseline in HbA1c Over Time in Double-blind Treatment Group | Week 6 | -0.72 percentage of HbA1c | Standard Error 0.065 |
| Double-blind Group: Bexagliflozin 20 mg | Change From Baseline in HbA1c Over Time in Double-blind Treatment Group | Week 12 | -0.97 percentage of HbA1c | Standard Error 0.073 |
| Double-blind Group: Bexagliflozin 20 mg | Change From Baseline in HbA1c Over Time in Double-blind Treatment Group | Week 18 | -1.00 percentage of HbA1c | Standard Error 0.072 |
| Double-blind Group: Bexagliflozin 20 mg | Change From Baseline in HbA1c Over Time in Double-blind Treatment Group | Week 24 | -1.09 percentage of HbA1c | Standard Error 0.076 |
| Double-blind Group: Placebo | Change From Baseline in HbA1c Over Time in Double-blind Treatment Group | Week 24 | -0.56 percentage of HbA1c | Standard Error 0.075 |
| Double-blind Group: Placebo | Change From Baseline in HbA1c Over Time in Double-blind Treatment Group | Week 6 | -0.16 percentage of HbA1c | Standard Error 0.065 |
| Double-blind Group: Placebo | Change From Baseline in HbA1c Over Time in Double-blind Treatment Group | Week 18 | -0.51 percentage of HbA1c | Standard Error 0.072 |
| Double-blind Group: Placebo | Change From Baseline in HbA1c Over Time in Double-blind Treatment Group | Week 12 | -0.31 percentage of HbA1c | Standard Error 0.073 |
Comparison: Model-adjusted change from baseline at week 6 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.p-value: <0.000195% CI: [-0.74, -0.38]Mixed-effects repeated measures
Comparison: Model-adjusted change from baseline at week 12 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.p-value: <0.000195% CI: [-0.86, -0.46]Mixed-effects repeated measures
Comparison: Model-adjusted change from baseline at week 18 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.p-value: <0.000195% CI: [-0.69, -0.3]Mixed-effects repeated measures
Comparison: Model-adjusted change from baseline at week 24 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.p-value: <0.000195% CI: [-0.74, -0.32]Mixed-effects repeated measures
Secondary
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
Population: The ITT population was used for the analysis. Subjects with a value at baseline and at the specific visit were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Change From Baseline in Systolic Blood Pressure (SBP) at Week 24 | -5.03 mm Hg | Standard Error 0.993 |
| Double-blind Group: Placebo | Change From Baseline in Systolic Blood Pressure (SBP) at Week 24 | 2.04 mm Hg | Standard Error 0.987 |
| High Glycemic Group | Change From Baseline in Systolic Blood Pressure (SBP) at Week 24 | -8.19 mm Hg | Standard Error 14.882 |
p-value: <0.000195% CI: [-9.83, -4.32]Mixed-effects repeated measures
Secondary
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
Population: Subjects with a BMI \>= 25 kg/m2 at baseline in the ITT population were included. The number of subjects with a value at baseline and at week 24 was analyzed. Model-adjusted mean change (LS Mean) and standard error (SE) were reported.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group | -3.60 kg | Standard Error 0.348 |
| Double-blind Group: Placebo | Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group | -1.09 kg | Standard Error 0.336 |
p-value: <0.000195% CI: [-3.45, -1.57]ANCOVA
Secondary
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
Population: Subjects with a BMI \>= 25 kg/m2 at baseline in the ITT population were included. The number of subjects with a value at baseline and at week 24 was analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group | -1.40 kg | Standard Deviation 3.759 |
Secondary
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
Population: The Number Analyzed only includes the number of subjects with a value at baseline and at the specific visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0% | Week 6 | -1.72 percentage of HbA1c | Standard Deviation 1.027 |
| Double-blind Group: Bexagliflozin 20 mg | Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0% | Week 12 | -2.45 percentage of HbA1c | Standard Deviation 1.136 |
| Double-blind Group: Bexagliflozin 20 mg | Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0% | Week 18 | -2.62 percentage of HbA1c | Standard Deviation 1.055 |
| Double-blind Group: Bexagliflozin 20 mg | Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0% | Week 24 | -2.82 percentage of HbA1c | Standard Deviation 1.084 |
Secondary
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
Population: The number of subjects in the ITT population with a value at baseline and at the specified visit was included. Model-adjusted proportion (LS proportion) and 95% confidence interval were reported for Double-blind Treatment Group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group | Week 6 | 0.14 Proportion of subjects |
| Double-blind Group: Bexagliflozin 20 mg | Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group | Week 12 | 0.26 Proportion of subjects |
| Double-blind Group: Bexagliflozin 20 mg | Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group | Week 18 | 0.26 Proportion of subjects |
| Double-blind Group: Bexagliflozin 20 mg | Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group | Week 24 | 0.38 Proportion of subjects |
| Double-blind Group: Placebo | Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group | Week 24 | 0.10 Proportion of subjects |
| Double-blind Group: Placebo | Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group | Week 6 | 0.03 Proportion of subjects |
| Double-blind Group: Placebo | Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group | Week 18 | 0.10 Proportion of subjects |
| Double-blind Group: Placebo | Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group | Week 12 | 0.06 Proportion of subjects |
Comparison: Odds ratio at Week 6 was calculated as the odds ratio of bexagliflozin group over placebo group.p-value: 0.001495% CI: [1.7, 12.95]Mixed-effects repeated measures
Comparison: Odds ratio at Week 12 was calculated as the odds ratio of bexagliflozin group over placebo group.p-value: 0.000195% CI: [1.96, 8.92]Mixed-effects repeated measures
Comparison: Odds ratio at Week 18 was calculated as the odds ratio of bexagliflozin group over placebo group.p-value: 0.00395% CI: [1.31, 5.04]Mixed-effects repeated measures
Comparison: Odds ratio at Week 24 was calculated as the odds ratio of bexagliflozin group over placebo group.p-value: <0.000195% CI: [1.99, 7.58]Mixed-effects repeated measures
Secondary
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
Population: The number of subjects in the ITT population with a value at baseline and at the specified visit was included. Proportion of subjects achieving HbA1c \< 7% was reported for High Glycemic Group without a 95% confidence interval.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-blind Group: Bexagliflozin 20 mg | Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group | Week 6 | 0 Proportion of subjects |
| Double-blind Group: Bexagliflozin 20 mg | Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group | Week 12 | 0.065 Proportion of subjects |
| Double-blind Group: Bexagliflozin 20 mg | Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group | Week 18 | 0.097 Proportion of subjects |
| Double-blind Group: Bexagliflozin 20 mg | Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group | Week 24 | 0.138 Proportion of subjects |