Type 2 Diabetes MellitusPhase 3NCT02769481

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

A Phase 3 study testing Bexagliflozin and Glimepiride in people with Type 2 Diabetes Mellitus, run by Theracos at 45 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Bexagliflozin and Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 426 participants
Where: 45 sitesin 4 countries
Study dates: 15 Aug 2016to 14 Jun 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of T2DM
Currently taking metformin or taking metformin and one additional oral medication for diabetes
Body Mass Index (BMI) ≤ 45 kg/m2
Stable dose of blood pressure or cholesterol medications (if applicable) for at least 30 days

Who cannot join

Hypersensitivity or other contraindication to the safe use of sulfonylurea or glimepiride
Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs
History of genitourinary tract infections
Evidence of abnormal liver function
Myocardial infarction, stroke or hospitalization for heart failure within 3 months of screening
Prior kidney transplant or evidence of kidney problems
Pregnant or nursing

Trial locations and contacts

45 sites in 4 countries.

Country

City, postcode or hospital

45 sites in 4 countries

Poland16 sites

Research Site
Bochnia, 32-700
Research Site
Bydgoszcz, 85-312
Research Site
Krakow, 30-015
Research Site 2
Krakow, 31-011
Research Site
Lodz, 90-242
Research Site 2
Lublin, 20-064
Research Site
Lublin, 20-362
Research Site
Olsztyn, 10-117
Research Site
Poznan, 61-655
Research Site
Puławy, 24-100
Research Site
Staszów, 28-200
Research Site
Swarzędz, 62-020
Research Site
Świdnik, 21-040
Research Site
Torun, 87-100
Research Site
Warsaw, 00-660
Research Site
Zamość, 22-400

Other trials in Poland

United States11 sites

Research Site
Birmingham, Alabama, 35205
Research Site
Calabash, North Carolina, 28467
Research Site
Hialeah, Florida, 33012
Research Site
Huntington Park, California, 90255
Research Site
Los Angeles, California, 90057
Research Site
Magnolia, Texas, 77355
Research Site
Miami Lakes, Florida, 33016
Research Site
Morehead City, North Carolina, 28557
Research Site
Orlando, Florida, 32806
Research Site
San Carlos, California, 94070
Research Site
West Palm Beach, Florida, 33401

Other trials in United States

Spain10 sites

Research Site
Alicante
Research Site 2
Barcelona
Research Site
Barcelona
Research Site 2
Madrid
Research Site 3
Madrid
Research Site
Madrid
Research Site 2
Málaga
Research Site
Málaga
Research Site 2
Oviedo
Research Site
Valencia

Other trials in Spain

Germany8 sites

Research Site
Aschaffenburg, 63739
Research Site
Essen, 45277
Research Site 2
Essen, 45355
Research Site 2
Hamburg, 21073
Research Site
Hamburg, 22607
Research Site
Heidelberg, 69115
Research Site
Magdeburg, 39120
Research Site
Wangen, 88239

Other trials in Germany

About this study

Official title: A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin

Read the detailed description

Approximately 420 subjects with inadequately controlled T2DM on metformin will be recruited from North America and Europe. Subjects will be randomly assigned to receive bexagliflozin tablets, 20 mg, or glimepiride capsules, 2, 4 or 6 mg, in a ratio of 1:1 once daily for 96 weeks. Subjects will continue to take metformin for the duration of the study.

Conditions: Type 2 Diabetes Mellitus
Being tested: Bexagliflozin, Placebo for Bexagliflozin, Glimepiride, Placebo for Glimepiride
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BexagliflozinDrug
Also called EGT0001442
20 mg, tablet
Placebo for BexagliflozinDrug
inactive tablet to match active comparator bexagliflozin
GlimepirideDrug
2, 4 or 6 mg, capsule
Placebo for GlimepirideDrug
inactive capsules to match active comparator glimepiride

Study groups in NCT02769481
Study group	Role	What they receive
Bexagliflozin	Active comparator	Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride daily for the duration of the study. Receives: Drug: Bexagliflozin; Drug: Placebo for Glimepiride
Glimepiride	Active comparator	Subjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study. Receives: Drug: Placebo for Bexagliflozin; Drug: Glimepiride

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in HbA1c at Week 60
The primary objective is to demonstrate that bexagliflozin is non-inferior to glimepiride by evaluating the treatment effect on HbA1c reduction at week 60 in subjects whose T2DM is inadequately controlled by metformin. The least square mean (LSM) change from baseline to Week 60 was analyzed using a mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA).
Measured: Baseline and Week 60

Secondary outcomes (4)

Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2
Least squares (LS) mean treatment difference between the bexagliflozin group and placebo group in the change of body weight in subjects with baseline BMI ≥ 25 kg/m2 at week 60 is analyzed using ANCOVA.
Measured: Baseline and 60 weeks
Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg
Least squares (LS) mean treatment difference between the bexagliflozin group and placebo group in the change of SBP in subjects with baseline SBP ≥ 140 mmHg at week 60 is analyzed using ANCOVA.
Measured: Baseline and 60 weeks
Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks
The difference in proportion of subjects with ≥ 1 severe or documented symptomatic hypoglycemia events in the bexagliflozin group compared with glimepiride group over 96 weeks is analyzed using a logistic regression model. The full model included region, baseline HbA1c value, background treatment status (metformin or metformin + OHA), eGFR at baseline ≥ 90 or < 90 mL min 1 per 1.73 m2), treatment as a fixed effect covariate.
Measured: During the 96 week treatment period
Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.
Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% CI is less than 0.
Measured: Baseline to Week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201614 Jun 2019

First posted11 May 2016 (estimated)
Study start15 Aug 2016
Primary completion14 Jun 2019
Study completion14 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02769481
Sponsor's protocol ID: THR-1442-C-480
Status last verified: May 2021
First submitted: 3 May 2016
Last updated: 27 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin
ClinicalTrials.gov ID: NCT02769481
Acronym / sponsor ID: THR-1442-C-480
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 426 participants (actual)
Lead sponsor: TheracosIndustry (pharma, biotech, devices)
Study start: 15 Aug 2016 (actual)
Primary completion: 14 Jun 2019 (actual)
Study completion: 14 Jun 2019 (actual)
First posted: 11 May 2016 (estimated)
Results: Posted 27 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bexagliflozin	Active comparator	Drug: Bexagliflozin, Drug: Placebo for GlimepirideSubjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for glimepiride daily for the duration of the study.
Glimepiride	Active comparator	Drug: Placebo for Bexagliflozin, Drug: GlimepirideSubjects will receive a glimepiride capsule, 2, 4 or 6 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of T2DM
Currently taking metformin or taking metformin and one additional oral medication for diabetes
Body Mass Index (BMI) ≤ 45 kg/m2
Stable dose of blood pressure or cholesterol medications (if applicable) for at least 30 days

Key exclusion criteria (8 listed)

Hypersensitivity or other contraindication to the safe use of sulfonylurea or glimepiride
Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs
History of genitourinary tract infections
Evidence of abnormal liver function

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BexagliflozinAlso: EGT000144220 mg, tablet	Drug	Bexagliflozin
Placebo for Bexagliflozininactive tablet to match active comparator bexagliflozin	Drug	Glimepiride
Glimepiride2, 4 or 6 mg, capsule	Drug	Glimepiride
Placebo for Glimepirideinactive capsules to match active comparator glimepiride	Drug	Bexagliflozin

Primary outcome

Change From Baseline in HbA1c at Week 60
Time frame: Baseline and Week 60
The primary objective is to demonstrate that bexagliflozin is non-inferior to glimepiride by evaluating the treatment effect on HbA1c reduction at week 60 in subjects whose T2DM is inadequately controlled by metformin. The least square mean (LSM) change from baseline to Week 60 was analyzed using a mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA).

4 secondary outcomes

Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2
Time frame: Baseline and 60 weeks
Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg
Time frame: Baseline and 60 weeks
Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks
Time frame: During the 96 week treatment period
Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.
Time frame: Baseline to Week 60

Results and safety

Results posted to the registry on 27 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bexagliflozin	213	180
Glimepiride	213	177

Primary outcome: Change From Baseline in HbA1c at Week 60

Time frame: Baseline and Week 60. Least squares mean (Standard Error). Unit: percentage of glycated hemoglin

Measure	Bexagliflozin n = 193	Glimepiride n = 191
Value	-0.70 (0.058)	-0.66 (0.058)

Bexagliflozin vs Glimepiride: Mean Difference (Final Values): 0.05 (95% CI -0.21 to 0.11)

Population analysed: The intention-to-treat population was used for the analysis. Subjects with a value at baseline and at week 60 were analyzed.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from Week -8 (V2, wash-out) to Week 98 (V18, follow-up).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bexagliflozin	25 of 213 (11.7%)	98 of 213 (46%)	0 of 213
Glimepiride	26 of 213 (12.2%)	112 of 213 (52.6%)	1 of 213

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes Mellitus

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

J. Paul Lock, MD study director

Theracos Sub, LLC

45 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bexagliflozin and Glimepiride in people with Type 2 Diabetes Mellitus, run by Theracos at 45 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Poland, United States, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c at Week 60 (time frame: Baseline and Week 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02769481.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.