Do you struggle to manage your type 2 diabetes?

You may be eligible to participate in a clinical trial for an alternative treatment

Do you struggle to manage your type 2 diabetes? You may be eligible to participate in a clinical trial for an alternative treatment

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Type 2 Diabetes Clinical Trial

NCT03259789 | Phase 3 | Interventional

What you may receive

Study related treatment at no cost

Travel expenses covered

No insurance needed

Do you struggle to manage your type 2 diabetes?

You may be eligible to participate in a clinical trial for an alternative treatment

Do you struggle to manage your type 2 diabetes? You may be eligible to participate in a clinical trial for an alternative treatment

Completed

Male & Female

20 Years +

This study has recruited 351 Participants

Hundreds of millions of people have diabetes worldwide– and those numbers continue to climb. Over 90% of people with diabetes have Type 2 Diabetes (T2D). It is one of the leading causes of heart disease, stroke, blindness, kidney disease, amputation and death. Diet, exercise, and education are important in the management of T2D, but many people also require drug therapy to manage their illness. Maintaining blood glucose levels within the recommended range is a difficult goal to achieve without increasing your risk of hypoglycemia (low blood sugar). This study is evaluating an investigational oral tablet that may help manage your blood glucose levels.

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Why should I participate?

This investigational oral tablet combined with diet and exercise, may help manage blood glucose levels in people with Type 2 Diabetes (T2D). Additionally, the knowledge gained from the studies may help other people with T2D in the future.

What's involved?

In the study, you will randomly be assigned to receive the investigational oral tablet, glimepiride, or a placebo. Participants will be required to attend regular office visits throughout the duration of the study. You will be given glucose monitoring supplies and asked to record your blood glucose levels and any symptoms you might be having in a diary. You may also have the following assessments evaluated: physical exam, vital signs, blood and urine tests; and diet, exercise, and health education.

Who can participate?

You may be eligible to participate if you:
» Are diagnosed with Type 2 Diabetes
» Are 18 years of age or older
» Have HbA1c levels between 7-10%
» Are currently being treated with Metformin, Metformin can be marketed under the brand names Glumetza, Glucophage, Fortamet, Riomet, and Glucophage XR.

Details for the study

Brief Title

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

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Bexagliflozin in Subjects With Type 2 Diabetes Mellitus Who Are Not Adequately Controlled by Metformin Alone

Brief Summary

The purpose of this study is to investigate the effect of bexagliflozin compared to placebo <br /> as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with <br /> 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.

Treatments and/or Procedures

Bexagliflozin tablets 20 mg

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

Bexagliflozin tablets placebo

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Baseline to week 24

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.

Baseline to week 24

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.

Baseline, up to 24 weeks

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

Baseline to week 24

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.

Baseline to week 24

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.

Baseline, up to 24 weeks

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

Baseline to week 24

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.

Baseline, up to 24 weeks

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.

Baseline, up to 24 weeks

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

Baseline, up to 24 weeks

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.

Baseline, up to 24 weeks

Study 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