Type2 Diabetes MellitusPhase 1NCT02956044

Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin

A Phase 1 study testing Bexagliflozin, Metformin and Glimepiride in people with Type2 Diabetes Mellitus, run by Theracos at 1 site in United States.

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Type2 Diabetes Mellitus
What is being tested?: Bexagliflozin, Metformin and Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: Nov 2016to Mar 2017
Phase: Phase 1
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 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
Subjects who are non-smokers for at least 3 months prior to screening
Subjects who are willing and able to be confined to the clinical research facility as required by the protocol

Who cannot join

Subjects with a clinically significant history of allergy to drugs or latex.
Subjects with a history of alcohol or drug dependence in the past 12 months.
Subjects who have donated a significant amount of blood in the past 2 months
Female subjects who are pregnant or breastfeeding
Subjects who are not willing to use an adequate form of birth control during the study and for 30 days after discharge from clinic
Subjects who have taken an investigational drug in the past 30 days or 7 half-lives of the investigational drug, whichever is longer
Subjects who had previously received anti-diabetic medication, including metformin, sitagliptin, glimepiride or drugs of the same class (i.e. biguanides, DPP-4 inhibitors or sulfonylureas), or SGLT2 inhibitors, in the past 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research Site
Evansville, Indiana, 47710

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Randomized, Three-period, Crossover Study to Evaluate Pharmacokinetic Interaction Between Bexagliflozin Tablets and Metformin, Glimepiride, or Sitagliptin in Healthy Subjects

The purpose of this study is to examine the drug-drug interaction in your body when given the study drug, bexagliflozin, with three commonly used ant-diabetic medications, metformin, glimepiride or sitagliptin. The study will also evaluate how safe the study drug is and how well the study drug is tolerated when taken with metformin, glimepiride or sitagliptin.

Read the detailed description

A total of 54 healthy subjects were enrolled and assigned to one of three groups of eighteen. Each group participated in one of three open-label, randomized, three treatment period, crossover studies:

Group 1: Bexagliflozin/metformin drug-drug interaction (DDI)
Group 2: Bexagliflozin/glimepiride DDI
Group 3: Bexagliflozin/sitagliptin DDI For each Group, every subject received a single dose of bexagliflozin tablet, 20 mg, alone, a single dose of an oral hypoglycemic agent (OHA) (1000 mg metformin, 2 mg glimepiride, or 100 mg sitagliptin) alone, and the combination of both (bexagliflozin tablet and OHA) alternately in a crossover fashion, with three treatment periods separated by a washout period of at least 7 days. Within each Group, subjects were randomized to one of six treatment sequences in an equal ratio.

To prevent hypoglycemia, subjects assigned to Group 2 (bexagliflozin/glimepiride DDI) received approximately 300 mL of a solution containing 50 g of glucose with study medication at the time of dosing, as well as approximately 75 mL of a solution containing 12.5 g of glucose every 15 minutes for 4 hours post-dose.

For each treatment period in Group 1 (bexagliflozin/metformin DDI) and Group 2 (bexagliflozin/glimepiride DDI), subjects were admitted to the clinic on the day before dosing and stayed in the clinic until 48 h post-dose. For Group 3 (bexagliflozin/sitagliptin DDI), subjects stayed in the clinic until 72 h post-dose.

For all Groups, blood samples for PK analysis were collected in each period prior to dosing (pre-dose) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose. For Group 3, PK blood samples were also collected at 60 and 72 h post-dose. Plasma concentrations of bexagliflozin and OHAs were determined by validated liquid chromatography tandem mass spectrometry (LC MS/MS) assays.

Urine samples for PD analysis were collected in 12 h intervals. For all Groups, urine samples were collected pre-dose (-12 to 0 h) and post-dose at 0 to 12 h, 12 to 24 h, 24 to 36 h, and 36 to 48 h. For Group 3, additional samples at 48 to 60 h and 60 to 72 h post-dose were collected.

Conditions: Type2 Diabetes Mellitus
Being tested: Bexagliflozin, Metformin, Glimepiride, Sitagliptin

What participants receive

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

BexagliflozinDrug
Bexagliflozin tablets, 20 mg
MetforminDrug
1000 mg metformin
GlimepirideDrug
4 mg glimepiride
SitagliptinDrug
100 mg sitagliptin

Study groups in NCT02956044
Study group	Role	What they receive
Group 1: Bexagliflozin alone	Active comparator	Not described Receives: Drug: Bexagliflozin
Group 1: Metformin alone	Active comparator	Not described Receives: Drug: Metformin
Group 1: Bexagliflozin + Metformin	Active comparator	Not described Receives: Drug: Bexagliflozin; Drug: Metformin
Group 2: Bexagliflozin alone	Active comparator	Not described Receives: Drug: Bexagliflozin
Group 2: Glimepiride alone	Active comparator	Not described Receives: Drug: Glimepiride
Group 2: Bexagliflozin + Glimepiride	Active comparator	Not described Receives: Drug: Bexagliflozin; Drug: Glimepiride
Group 3: Bexagliflozin alone	Active comparator	Not described Receives: Drug: Bexagliflozin
Group 3: Sitagliptin alone	Active comparator	Not described Receives: Drug: Sitagliptin
Group 3: Bexagliflozin + Sitagliptin	Active comparator	Not described Receives: Drug: Bexagliflozin; Drug: Sitagliptin

What is being measured

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

Cmax (Maximum Observed Plasma Concentration)
Whole venous blood samples of 5 mL were be collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. Pharmacokinetic (PK) blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Cmax was obtained directly from experimental observations.
Measured: Up to 72 hours
Tmax (Time of Maximum Observed Plasma Concentration)
Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Tmax was obtained directly from experimental observations.
Measured: Up to 72 hours
T1/2 (Apparent Terminal Elimination Half-life)
Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. T1/2 was obtained directly from experimental observations.
Measured: Up to 72 hours
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)
Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. AUC0-inf was estimated for each subject.
Measured: Up to 72 hours

Secondary outcomes (1)

Urinary Glucose Excretion up to 0-72 hr
Pre-dose urine samples were collected from -12 to 0 h for baseline measurement. Subjects was instructed to empty their bladder prior to dosing. Post-dose urine was collected in 4 batches for Groups 1 and 2 at 0 to 12 h, 12 to 24 h, 24 o 36 h, and 36 to 48 h collections. Post-dose urine was collected in batches for Group 3 at 0 to 12 h, 12 to 24 h, 24 to 36 h, 36 to 48 h, 48 to 60 h and 60 to 72 h.
Measured: up to 0-72 hr

Timeline

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

Nov 2016Mar 2017

First posted4 Nov 2016 (estimated)
Study startNov 2016
Primary completionMar 2017
Study completionMar 2017

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 Type2 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02956044
Sponsor's protocol ID: THR-1442-C-453
Status last verified: Jul 2021
First submitted: 2 Nov 2016
Last updated: 22 Jul 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 Type2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, Three-period, Crossover Study to Evaluate Pharmacokinetic Interaction Between Bexagliflozin Tablets and Metformin, Glimepiride, or Sitagliptin in Healthy Subjects
ClinicalTrials.gov ID: NCT02956044
Acronym / sponsor ID: THR-1442-C-453
Conditions: Type2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: TheracosIndustry (pharma, biotech, devices)
Study start: Nov 2016
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 4 Nov 2016 (estimated)
Results: Posted 22 Jul 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

Group 1: Bexagliflozin/metformin drug-drug interaction (DDI)
Group 2: Bexagliflozin/glimepiride DDI
Group 3: Bexagliflozin/sitagliptin DDI For each Group, every subject received a single dose of bexagliflozin tablet, 20 mg, alone, a single dose of an oral hypoglycemic agent (OHA) (1000 mg metformin, 2 mg glimepiride, or 100 mg sitagliptin) alone, and the combination of both (bexagliflozin tablet and OHA) alternately in a crossover fashion, with three treatment periods separated by a washout period of at least 7 days. Within each Group, subjects were randomized to one of six treatment sequences in an equal ratio.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Group 1: Bexagliflozin alone	Active comparator	Drug: Bexagliflozin
Group 1: Metformin alone	Active comparator	Drug: Metformin
Group 1: Bexagliflozin + Metformin	Active comparator	Drug: Bexagliflozin, Drug: Metformin
Group 2: Bexagliflozin alone	Active comparator	Drug: Bexagliflozin
Group 2: Glimepiride alone	Active comparator	Drug: Glimepiride
Group 2: Bexagliflozin + Glimepiride	Active comparator	Drug: Bexagliflozin, Drug: Glimepiride
Group 3: Bexagliflozin alone	Active comparator	Drug: Bexagliflozin
Group 3: Sitagliptin alone	Active comparator	Drug: Sitagliptin
Group 3: Bexagliflozin + Sitagliptin	Active comparator	Drug: Bexagliflozin, Drug: Sitagliptin

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects with body-mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2
Subjects who are non-smokers for at least 3 months prior to screening
Subjects who are willing and able to be confined to the clinical research facility as required by the protocol

Key exclusion criteria (7 listed)

Subjects with a clinically significant history of allergy to drugs or latex.
Subjects with a history of alcohol or drug dependence in the past 12 months.
Subjects who have donated a significant amount of blood in the past 2 months
Female subjects who are pregnant or breastfeeding
Subjects who are not willing to use an adequate form of birth control during the study and for 30 days after discharge from clinic

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
BexagliflozinBexagliflozin tablets, 20 mg	Drug	Group 1: Bexagliflozin + Metformin, Group 1: Bexagliflozin alone, Group 2: Bexagliflozin + Glimepiride, Group 2: Bexagliflozin alone, Group 3: Bexagliflozin + Sitagliptin, Group 3: Bexagliflozin alone
Metformin1000 mg metformin	Drug	Group 1: Bexagliflozin + Metformin, Group 1: Metformin alone
Glimepiride4 mg glimepiride	Drug	Group 2: Bexagliflozin + Glimepiride, Group 2: Glimepiride alone
Sitagliptin100 mg sitagliptin	Drug	Group 3: Bexagliflozin + Sitagliptin, Group 3: Sitagliptin alone

Primary outcome

Cmax (Maximum Observed Plasma Concentration)
Time frame: Up to 72 hours
Whole venous blood samples of 5 mL were be collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. Pharmacokinetic (PK) blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Cmax was obtained directly from experimental observations.
Tmax (Time of Maximum Observed Plasma Concentration)
Time frame: Up to 72 hours
Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. Tmax was obtained directly from experimental observations.
T1/2 (Apparent Terminal Elimination Half-life)
Time frame: Up to 72 hours
Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. T1/2 was obtained directly from experimental observations.
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)
Time frame: Up to 72 hours
Whole venous blood samples of 5 mL were collected from a peripheral vein in each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h post-dose for Group 1 and 2. PK blood samples were collected at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose for Group 3. Plasma was obtained from centrifugation, frozen and analyzed. AUC0-inf was estimated for each subject.

1 secondary outcome

Urinary Glucose Excretion up to 0-72 hr
Time frame: up to 0-72 hr

Results and safety

Results posted to the registry on 22 Jul 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
Group 1: Bexagliflozin + Metformin	18	18
Group 2: Bexagliflozin + Glimepiride	18	18
Group 3: Bexagliflozin + Sitagliptin	18	18

Primary outcome: Cmax (Maximum Observed Plasma Concentration)

Time frame: Up to 72 hours. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Group 1: Bexagliflozin Alone n = 18	Group 1: Metformin Alone n = 18	Group 1: Bexagliflozin + Metformin n = 18	Group 2: Bexagliflozin Alone n = 17	Group 2: Glimepiride Alone n = 18	Group 2: Bexagliflozin + Glimepiride n = 18	Group 3: Bexagliflozin Alone n = 18	Group 3: Sitagliptin Alone n = 18	Group 3: Bexagliflozin + Sitagliptin n = 18
Bexagliflozin PK parameters	124.6 (43.7)	–	135.5 (40.0)	158.6 (53.9)	–	143.7 (37.9)	117.1 (34.6)	–	148.3 (22.1)
Metformin PK parameters	–	2067.6 (27.2)	1965.2 (33.6)	–	–	–	–	–	–
Glimepiride PK parameters	–	–	–	–	59.9 (32.2)	67.1 (29.5)	–	–	–
Sitagliptin PK parameters	–	–	–	–	–	–	–	356.6 (22.3)	351.2 (32.9)

Group 1: Bexagliflozin Alone vs Group 1: Bexagliflozin + Metformin: Ratio of Geometric LSM: 108.73 (95% CI 94.35 to 125.30)
Group 1: Metformin Alone vs Group 1: Bexagliflozin + Metformin: Ratio of Geometric LSM: 95.05 (90% CI 84.73 to 106.63)
Group 2: Bexagliflozin Alone vs Group 2: Bexagliflozin + Glimepiride: Ratio of Geometric LSM: 89.44 (90% CI 70.39 to 113.65)

Population analysed: The study was designed to evaluate the potential bexagliflozin drug interactions. Study participants were dosed with bexagliflozin alone, other drug alone or both drugs sequentially. The pharmacokinetic parameters were calculated based on the specific analyte using samples collected after dosing of the drug. Therefore, not all samples were analyzed for all outcome measurements.

Primary outcome: Tmax (Time of Maximum Observed Plasma Concentration)

Time frame: Up to 72 hours. Median (Full Range). Unit: hours

Measure	Group 1: Bexagliflozin Alone n = 18	Group 1: Metformin Alone n = 18	Group 1: Bexagliflozin + Metformin n = 18	Group 2: Bexagliflozin Alone n = 17	Group 2: Glimepiride Alone n = 18	Group 2: Bexagliflozin + Glimepiride n = 18	Group 3: Bexagliflozin Alone n = 18	Group 3: Sitagliptin Alone n = 18	Group 3: Bexagliflozin + Sitagliptin n = 18
Bexagliflozin PK parameters	4.0 (1 to 5)	–	3.0 (1 to 5)	8.0 (5 to 10)	–	6.0 (5 to 10)	3.0 (2 to 5)	–	4.0 (2 to 5)
Metformin PK parameters	–	2.5 (1 to 3)	2.0 (1 to 5)	–	0 (0 to 0)	–	–	–	–
Glimepiride PK parameters	–	–	–	–	5.5 (1 to 10)	7.0 (1 to 10)	–	–	–
Sitagliptin PK parameters	–	–	–	–	–	–	–	2.5 (1 to 5)	2.5 (1 to 6)

Primary outcome: T1/2 (Apparent Terminal Elimination Half-life)

Time frame: Up to 72 hours. Geometric mean (Geometric Coefficient of Variation). Unit: hours

Measure	Group 1: Bexagliflozin Alone n = 18	Group 1: Metformin Alone n = 18	Group 1: Bexagliflozin + Metformin n = 18	Group 2: Bexagliflozin Alone n = 17	Group 2: Glimepiride Alone n = 18	Group 2: Bexagliflozin + Glimepiride n = 18	Group 3: Bexagliflozin Alone n = 17	Group 3: Sitagliptin Alone n = 18	Group 3: Bexagliflozin + Sitagliptin n = 18
Bexagliflozin PK parameters	10.3 (30.4)	–	7.8 (48.6)	8.0 (33.3)	–	7.8 (34.4)	12.6 (48)	–	13.3 (38.2)
Metformin PK parameters	–	9.0 (31.8)	10.2 (32.5)	–	–	–	–	–	–
Glimepiride PK parameters	–	–	–	–	7.8 (46.8)	6.6 (57.8)	–	–	–
Sitagliptin PK parameters	–	–	–	–	–	–	–	14.3 (22.3)	14.8 (24.5)

Primary outcome: AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)

Time frame: Up to 72 hours. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Group 1: Bexagliflozin Alone n = 18	Group 1: Metformin Alone n = 18	Group 1: Bexagliflozin + Metformin n = 18	Group 2: Bexagliflozin Alone n = 17	Group 2: Glimepiride Alone n = 18	Group 2: Bexagliflozin + Glimepiride n = 18	Group 3: Bexagliflozin Alone n = 18	Group 3: Sitagliptin Alone n = 18	Group 3: Bexagliflozin + Sitagliptin n = 18
Bexagliflozin PK parameters	1154.4 (35.1)	–	1008.6 (40.2)	1204.9 (48.6)	–	1162.2 (47.8)	1011.8 (21.5)	–	1158.1 (21.9)
Metformin PK parameters	–	13351.9 (22.5)	13784.6 (26.0)	–	–	–	–	–	–
Glimepiride PK parameters	–	–	–	–	496.1 (53.3)	633.0 (38.5)	–	–	–
Sitagliptin PK parameters	–	–	–	–	–	–	–	3579.6 (14.7)	3692.8 (16.9)

Group 1: Bexagliflozin Alone vs Group 1: Bexagliflozin + Metformin: Ratio of Geometric LSM: 87.36 (90% CI 80.02 to 95.38)
Group 1: Metformin Alone vs Group 1: Bexagliflozin + Metformin: Ratio of Geometric LSM: 103.24 (90% CI 94.59 to 112.68)
Group 2: Bexagliflozin Alone vs Group 2: Bexagliflozin + Glimepiride: Ratio of Geometric LSM: 94.46 (90% CI 80.34 to 111.06)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event collection began on the first clinical admission day (Day 0) and continued through D17. The subjects were actively monitored for serious adverse events for at least 14 days after discharge from the study.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Bexagliflozin Alone	0 of 18 (0%)	3 of 18 (16.7%)	0 of 18
Group 1: Metformin Alone	0 of 18 (0%)	11 of 18 (61.1%)	0 of 18
Group 1: Bexagliflozin + Metformin	0 of 18 (0%)	13 of 18 (72.2%)	0 of 18
Group 2: Bexagliflozin Alone	0 of 18 (0%)	6 of 18 (33.3%)	0 of 18
Group 2: Glimepiride Alone	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18
Group 2: Bexagliflozin + Glimepiride	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18
Group 3: Bexagliflozin Alone	0 of 18 (0%)	3 of 18 (16.7%)	0 of 18
Group 3: Sitagliptin Alone	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18
Group 3: Bexagliflozin + Sitagliptin	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Mason Freeman, M.D. study chair

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bexagliflozin, Metformin and Glimepiride in people with Type2 Diabetes Mellitus, run by Theracos at 1 site in United States.

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 3 inclusion and 7 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 22 Jul 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?

Cmax (Maximum Observed Plasma Concentration) (time frame: Up to 72 hours). The study lists 4 primary outcomes in all. 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 NCT02956044.

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 22 Jul 2021.