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

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ClinicalTrials.gov Identifier: NCT02769481

Recruitment Status : Completed

First Posted : May 11, 2016

Results First Posted : May 27, 2021

Last Update Posted : May 27, 2021

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Sponsor:

Information provided by (Responsible Party):

Theracos

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Interventions	Drug: Bexagliflozin Drug: Placebo for Bexagliflozin Drug: Glimepiride Drug: Placebo for Glimepiride
Enrollment	426

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Bexagliflozin	Glimepiride
Arm/Group Description	Subjects will receive a bexaglifloz...	Subjects will receive a glimepiride...
Arm/Group Description	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 for the duration of the study. Bexagliflozin tablets: 20 mg Glimepiride capsules: Placebo, inactive capsule to match the 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. Bexagliflozin: Placebo, inactive tablet to match the active comparator Glimepiride capsules: 2, 4 or 6 mg
Period Title: Overall Study
Started	213	213
Study Complete at Week 60	193	192
Completed	180	177
Not Completed	33	36
Reason Not Completed
Protocol Violation	1	0
Adverse Event	3	6
Entry Criteria Not Met	1	2
Withdrawal by Subject	14	16
Lost to Follow-up	9	9
Physician Decision	0	1
Terminated by Sponsor	1	0
Death	0	1
Undefined	4	1

Baseline Characteristics

Arm/Group Title		Bexagliflozin	Glimepiride	Total
Arm/Group Description		Subjects will receive a bexaglifloz...	Subjects will receive a glimepiride...	Total of all reporting groups
Arm/Group Description		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 for the duration of the study. Bexagliflozin tablets: 20 mg Glimepiride capsules: Placebo, inactive capsule to match the 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. Bexagliflozin: Placebo, inactive tablet to match the active comparator Glimepiride capsules: 2, 4 or 6 mg	Total of all reporting groups
Overall Number of Baseline Participants		213	213	426
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	213 participants	213 participants	426 participants
		59.5 (9.06)	59.7 (10.35)	59.6 (9.71)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	213 participants	213 participants	426 participants
	Female	95 44.6%	83 39.0%	178 41.8%
	Male	118 55.4%	130 61.0%	248 58.2%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	213 participants	213 participants	426 participants
	Hispanic or Latino	46 21.6%	47 22.1%	93 21.8%
	Not Hispanic or Latino	167 78.4%	166 77.9%	333 78.2%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	213 participants	213 participants	426 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	9 4.2%	4 1.9%	13 3.1%
	Native Hawaiian or Other Pacific Islander	1 0.5%	0 0.0%	1 0.2%
	Black or African American	5 2.3%	4 1.9%	9 2.1%
	White	198 93.0%	204 95.8%	402 94.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	1 0.5%	1 0.2%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	213 participants	213 participants	426 participants
United States		65	63	128
Poland		74	79	153
Germany		28	29	57
Spain		46	42	88
Height Mean (Standard Deviation) Unit of measure: Cm
	Number Analyzed	213 participants	213 participants	426 participants
		166.7 (11.13)	167.1 (9.53)	166.9 (10.35)
Body Weight at Baseline Mean (Standard Deviation) Unit of measure: Kg
	Number Analyzed	213 participants	213 participants	426 participants
		87.95 (19.122)	90.23 (17.616)	89.09 (18.399)
BMI Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	213 participants	213 participants	426 participants
		31.45 (4.861)	32.22 (5.155)	31.83 (5.019)
Systolic Blood Pressure at Baseline Mean (Standard Deviation) Unit of measure: Mm Hg
	Number Analyzed	213 participants	213 participants	426 participants
		133.3 (14.88)	134.2 (14.37)	133.8 (14.62)
Systolic Blood Pressure Categories Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	213 participants	213 participants	426 participants
< 140 mm Hg		135 63.4%	138 64.8%	273 64.1%
> 140 mm Hg		78 36.6%	75 35.2%	153 35.9%

Outcome Measures

1.Primary Outcome


Title	Change From Baseline in HbA1c at Week 60
Description	The primary objective is to demonstrate that bexagliflozin is non-infe...
Description	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).
Time Frame	Baseline and Week 60

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Bexagliflozin	Glimepiride
Arm/Group Description:	Subjects will receive a bexaglifloz...	Subjects will receive a glimepiride...
Arm/Group Description:	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 for the duration of the study. Bexagliflozin tablets: 20 mg Glimepiride capsules: Placebo, inactive capsule to match the 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. Bexagliflozin: Placebo, inactive tablet to match the active comparator Glimepiride capsules: 2, 4 or 6 mg
Overall Number of Participants Analyzed	193	191
Least Squares Mean (Standard Error) Unit of Measure: percentage of glycated hemoglin
	-0.70 (0.058)	-0.66 (0.058)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bexagliflozin, Glimepiride
	Comments	The null hypothesis for the primary endpoint was that the change in HbA1c from baseline to week 60 in the bexagliflozin arm would be greater than change in the glimepiride arm by greater than 0.35%.
	Type of Statistical Test	Non-Inferiority
	Comments	A 95% CI was to be calculated to estimate the range of values in which the treatment difference was likely to lie. If the 95% CI fell below the specified non inferiority margin of 0.35%, the non inferiority of bexagliflozin treatment to glimepiride treatment would be demonstrated and the null hypothesis would be rejected.

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95% -0.21 to 0.11
	Estimation Comments	A lower value represents a better treatment effect.

2.Secondary Outcome


Title	Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2
Description	Least squares (LS) mean treatment difference between the bexagliflozin...
Description	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.
Time Frame	Baseline and 60 weeks

Outcome Measure Data

Analysis Population Description

Number of subjects with a value at baseline and at the specified visit


Arm/Group Title	Bexagliflozin	Glimepiride
Arm/Group Description:	Subjects will receive a bexaglifloz...	Subjects will receive a glimepiride...
Arm/Group Description:	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 for the duration of the study. Bexagliflozin tablets: 20 mg Glimepiride capsules: Placebo, inactive capsule to match the 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. Bexagliflozin: Placebo, inactive tablet to match the active comparator Glimepiride capsules: 2, 4 or 6 mg
Overall Number of Participants Analyzed	182	182
Least Squares Mean (Standard Error) Unit of Measure: kg
	-3.71 (0.285)	0.59 (0.284)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bexagliflozin, Glimepiride
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	P-value is based on one sided statistical tests using a 0.025 level of significance.
	Method	Mixed-effects repeated measures
	Comments	Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.

Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-4.31
	Confidence Interval	(2-Sided) 95% -5.10 to -3.52
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg
Description	Least squares (LS) mean treatment difference between the bexagliflozin...
Description	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.
Time Frame	Baseline and 60 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Bexagliflozin	Glimepiride
Arm/Group Description:	Subjects will receive a bexaglifloz...	Subjects will receive a glimepiride...
Arm/Group Description:	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 for the duration of the study. Bexagliflozin tablets: 20 mg Glimepiride capsules: Placebo, inactive capsule to match the 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. Bexagliflozin: Placebo, inactive tablet to match the active comparator Glimepiride capsules: 2, 4 or 6 mg
Overall Number of Participants Analyzed	74	68
Least Squares Mean (Standard Error) Unit of Measure: mm Hg
	-13.48 (1.404)	-6.95 (1.460)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bexagliflozin, Glimepiride
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0008
	Comments	P-value is based on one sided statistical tests using a 0.025 level of significance.
	Method	Mixed-effects repeated measures
	Comments	Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.

Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-6.53
	Confidence Interval	(2-Sided) 95% -10.56 to -2.51
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks
Description	The difference in proportion of subjects with ≥ 1 severe or docu...
Description	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.
Time Frame	During the 96 week treatment period

Outcome Measure Data

Analysis Population Description

Subjects with post-baseline assessment.


Arm/Group Title	Bexagliflozin	Glimepiride
Arm/Group Description:	Subjects will receive a bexaglifloz...	Subjects will receive a glimepiride...
Arm/Group Description:	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 for the duration of the study. Bexagliflozin tablets: 20 mg Glimepiride capsules: Placebo, inactive capsule to match the 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. Bexagliflozin: Placebo, inactive tablet to match the active comparator Glimepiride capsules: 2, 4 or 6 mg
Overall Number of Participants Analyzed	213	212
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Proportion of participants
	0.02 (0.01 to 0.05)	0.15 (0.10 to 0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bexagliflozin, Glimepiride
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	P-value is based on one sided statistical tests using a 0.025 level of significance.
	Method	Regression, Logistic
	Comments	Region, baseline HbA1c, background treatment, eGFR at baseline, treatment as a fixed effect covariate.

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 95% 0.05 to 0.28
	Estimation Comments	Odds ratio is calculated as the odds ratio of bexagliflozin over glimepiride.

5.Secondary Outcome


Title	Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.
Description	Superiority of bexagliflozin over glimepiride in HbA1c reduction from ...
Description	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.
Time Frame	Baseline to Week 60

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Bexagliflozin	Glimepiride
Arm/Group Description:	Subjects will receive a bexaglifloz...	Subjects will receive a glimepiride...
Arm/Group Description:	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 for the duration of the study. Bexagliflozin tablets: 20 mg Glimepiride capsules: Placebo, inactive capsule to match the 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. Bexagliflozin: Placebo, inactive tablet to match the active comparator Glimepiride capsules: 2, 4 or 6 mg
Overall Number of Participants Analyzed	193	191
Least Squares Mean (Standard Error) Unit of Measure: percentage of glycated hemoglobin
	-0.70 (0.058)	-0.66 (0.058)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bexagliflozin, Glimepiride
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% confidence interval is less than 0

Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 95% -0.21 to 0.11
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Adverse event data was collected from Week -8 (V2, wash-out) to Week 98 (V18, follow-up).
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Bexagliflozin	Glimepiride
Arm/Group Description	Subjects will receive a bexaglifloz...	Subjects will receive a glimepiride...
Arm/Group Description	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 for the duration of the study. Bexagliflozin tablets: 20 mg Glimepiride capsules: Placebo, inactive capsule to match the 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. Bexagliflozin: Placebo, inactive tablet to match the active comparator Glimepiride capsules: 2, 4 or 6 mg
All-Cause Mortality
	Bexagliflozin	Glimepiride
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/213 (0.00%)	1/213 (0.47%)
Serious Adverse Events Serious Adverse Events
	Bexagliflozin	Glimepiride
	Affected / at Risk (%)	Affected / at Risk (%)
Total	25/213 (11.74%)	26/213 (12.21%)
Cardiac disorders
Acute myocardial infarction ^† 1	2/213 (0.94%)	1/213 (0.47%)
Myocardial ischemia ^† 1	1/213 (0.47%)	2/213 (0.94%)
Acute coronary syndrome ^† 1	1/213 (0.47%)	1/213 (0.47%)
Angina unstable ^† 1	0/213 (0.00%)	1/213 (0.47%)
Bradycardia ^† 1	0/213 (0.00%)	1/213 (0.47%)
Cardiac failure congestive ^† 1	0/213 (0.00%)	1/213 (0.47%)
Myocardial infarction ^† 1	0/213 (0.00%)	1/213 (0.47%)
Myocarditis ^† 1	1/213 (0.47%)	0/213 (0.00%)
Palpitation ^† 1	1/213 (0.47%)	0/213 (0.00%)
Congenital, familial and genetic disorders
Phimosis ^† 1	1/213 (0.47%)	0/213 (0.00%)
Ear and labyrinth disorders
Deafness unilateral ^† 1	0/213 (0.00%)	1/213 (0.47%)
Eye disorders
Ectropion ^† 1	1/213 (0.47%)	0/213 (0.00%)
Entropion ^† 1	1/213 (0.47%)	0/213 (0.00%)
Retinal detachment ^† 1	0/213 (0.00%)	1/213 (0.47%)
Gastrointestinal disorders
Faecaloma ^† 1	1/213 (0.47%)	0/213 (0.00%)
Inguinal hernia ^† 1	1/213 (0.47%)	0/213 (0.00%)
Small intestinal obstruction ^† 1	0/213 (0.00%)	1/213 (0.47%)
General disorders
Non-cardiac chest pain ^† 1	1/213 (0.47%)	0/213 (0.00%)
Hepatobiliary disorders
Cholelithiasis ^† 1	1/213 (0.47%)	1/213 (0.47%)
Infections and infestations
Pneumonia ^† 1	2/213 (0.94%)	2/213 (0.94%)
Erysipelas ^† 1	0/213 (0.00%)	1/213 (0.47%)
Otitis media chronic ^† 1	0/213 (0.00%)	1/213 (0.47%)
Pyelonephritis acute ^† 1	1/213 (0.47%)	0/213 (0.00%)
Metabolism and nutrition disorders
Hyponatremia ^† 1	0/213 (0.00%)	1/213 (0.47%)
Musculoskeletal and connective tissue disorders
Osteoarthritis ^† 1	1/213 (0.47%)	1/213 (0.47%)
Osteochondrosis ^† 1	0/213 (0.00%)	1/213 (0.47%)
Polyarthritis ^† 1	1/213 (0.47%)	0/213 (0.00%)
Spinal osteoarthritis ^† 1	1/213 (0.47%)	0/213 (0.00%)
Ankle fracture ^† 1	0/213 (0.00%)	1/213 (0.47%)
Contusion ^† 1	1/213 (0.47%)	0/213 (0.00%)
Muscle rupture ^† 1	1/213 (0.47%)	0/213 (0.00%)
Tibia fracture ^† 1	0/213 (0.00%)	1/213 (0.47%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma ^† 1	1/213 (0.47%)	0/213 (0.00%)
Small cell lung cancer ^† 1	0/213 (0.00%)	1/213 (0.47%)
Nervous system disorders
Transient ischemic attack ^† 1	1/213 (0.47%)	1/213 (0.47%)
Carotid artery stenosis ^† 1	1/213 (0.47%)	0/213 (0.00%)
Cerebrovascular accident ^† 1	1/213 (0.47%)	0/213 (0.00%)
Ischemic stroke ^† 1	0/213 (0.00%)	1/213 (0.47%)
Nervous system disorder ^† 1	0/213 (0.00%)	1/213 (0.47%)
Thalamic infarction ^† 1	1/213 (0.47%)	0/213 (0.00%)
Renal and urinary disorders
Nephrolithiasis ^† 1	0/213 (0.00%)	2/213 (0.94%)
Bladder disorder ^† 1	0/213 (0.00%)	1/213 (0.47%)
Reproductive system and breast disorders
Genital hemorrhage ^† 1	0/213 (0.00%)	1/213 (0.47%)
Uterine prolapse ^† 1	1/213 (0.47%)	0/213 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis ^† 1	0/213 (0.00%)	1/213 (0.47%)
Ecchymosis ^† 1	0/213 (0.00%)	1/213 (0.47%)
Vascular disorders
Arterial occlusive disease ^† 1	0/213 (0.00%)	1/213 (0.47%)
1 Term from vocabulary, MedDRA 19.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Bexagliflozin	Glimepiride
	Affected / at Risk (%)	Affected / at Risk (%)
Total	98/213 (46.01%)	112/213 (52.58%)
Infections and infestations
Nasopharyngitis ^† 1	29/213 (13.62%)	29/213 (13.62%)
Urinary Tract Infection ^† 1	25/213 (11.74%)	10/213 (4.69%)
Bronchitis ^† 1	14/213 (6.57%)	16/213 (7.51%)
Metabolism and nutrition disorders
Hypoglycemia ^† 1	36/213 (16.90%)	71/213 (33.33%)
Diabetes mellitus inadequate control ^† 1	1/213 (0.47%)	17/213 (7.98%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	6/213 (2.82%)	16/213 (7.51%)
Arthralgia ^† 1	13/213 (6.10%)	4/213 (1.88%)
1 Term from vocabulary, MedDRA 19.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Investigator has no publication right.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Albert Collinson
Organization:	Theracos Sub, LLC
Phone:	(508) 630-2129
EMail:	acollinson@theracos.com

Layout table for additonal information

Responsible Party:	Theracos
ClinicalTrials.gov Identifier:	NCT02769481
Other Study ID Numbers:	THR-1442-C-480
First Submitted:	May 3, 2016
First Posted:	May 11, 2016
Results First Submitted:	March 25, 2021
Results First Posted:	May 27, 2021
Last Update Posted:	May 27, 2021

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