Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus

• ClinicalTrials.gov Identifier: NCT01377844
• Recruitment Status: Completed
• First Posted: June 21, 2011
• Results First Posted: June 16, 2021
• Last Update Posted: July 1, 2021
• Sponsor: Theracos
• 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: Diabetes Mellitus
• Interventions: Drug: EGT0001442; Drug: Placebo
• Enrollment: 288

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	EGT0001442	Placebo
Arm/Group Description	EGT0001442 capsule, 20 mg, orally once daily	Placebo capsule, orally once daily
Period Title: Overall Study
Started	145	143
Safety Population [1]	145	141
Completed	109	108
Not Completed	36	35
Reason Not Completed
Withdrawal by Subject	25	28
Protocol Violation	2	3
Adverse Event	3	0
Physician Decision	6	3
Study terminated by Sponsor	0	1
[1] Two subjects did not meet the eligibility criteria and were not dosed. They were excluded from the safety population.

Baseline Characteristics

Arm/Group Title		EGT0001442	Placebo	Total
Arm/Group Description		EGT0001442 capsule, 20 mg, orally once daily	Placebo capsule, 20 mg, orally once daily	Total of all reporting groups
Overall Number of Baseline Participants		145	141	286
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	145 participants	141 participants	286 participants
		56.2 (10.94)	54.7 (10.30)	55.4 (10.64)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	145 participants	141 participants	286 participants
	Female	78 53.8%	91 64.5%	169 59.1%
	Male	67 46.2%	50 35.5%	117 40.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	145 participants	141 participants	286 participants
	Hispanic or Latino	129 89.0%	125 88.7%	254 88.8%
	Not Hispanic or Latino	16 11.0%	16 11.3%	32 11.2%
	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	145 participants	141 participants	286 participants
	American Indian or Alaska Native	1 0.7%	1 0.7%	2 0.7%
	Asian	0 0.0%	1 0.7%	1 0.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	3 2.1%	2 1.4%	5 1.7%
	White	110 75.9%	112 79.4%	222 77.6%
	More than one race	31 21.4%	25 17.7%	56 19.6%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Body Mass Index; Mean (Standard Deviation); Unit of measure: Kg/m2
	Number Analyzed	145 participants	141 participants	286 participants
		29.7 (5.35)	30.6 (5.41)	30.1 (5.39)
Baseline HbA1c Category; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	145 participants	141 participants	286 participants
	< 8.5%	87 60.0%	100 70.9%	187 65.4%
	> 8.5%	58 40.0%	41 29.1%	99 34.6%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Hemoglobin A1c at 24 Weeks
Description	Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	EGT0001442	Placebo
Arm/Group Description:	EGT0001442 capsule, 20 mg, orally once daily	Placebo capsule, orally once daily
Overall Number of Participants Analyzed	140	131
Least Squares Mean (Standard Error); Unit of Measure: percentage of glycated hemoglobin
	-0.28 (0.194)	0.51 (0.200)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.53
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Changes in Systolic and Diastolic Blood Pressure at Week 24
Description	Changes from baseline in systolic and diastolic blood pressure in placebo and treatment group after 24 weeks of treatment
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	EGT0001442	Placebo
Arm/Group Description:	EGT0001442 capsule, 20 mg, orally once daily	Placebo capsule, orally once daily
Overall Number of Participants Analyzed	140	131
Least Squares Mean (Standard Error); Unit of Measure: mm Hg
Systolic blood pressure	-8.62 (1.903)	-3.08 (1.964)
Diastolic blood pressure	-3.07 (1.223)	-0.40 (1.275)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline systolic BP, baseline HbA1c category, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-5.53
	Confidence Interval	(2-Sided) 95%; -8.02 to -3.04
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0015
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline diastolic BP, baseline HbA1c category, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-2.67
	Confidence Interval	(2-Sided) 95%; -4.30 to -1.04
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Changes in Body Weight at Week 24
Description	Changes from baseline in body weight in placebo and treatment group after 24 weeks of treatment
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	EGT0001442	Placebo
Arm/Group Description:	EGT0001442 capsule, 20 mg, orally once daily	Placebo capsule, orally once daily
Overall Number of Participants Analyzed	128	104
Least Squares Mean (Standard Error); Unit of Measure: kg
	-2.95 (0.555)	-1.22 (0.592)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline weight, baseline HbA1c category, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-1.72
	Confidence Interval	(2-Sided) 95%; -2.52 to -0.93
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change From Baseline in HbA1c Over 96 Weeks Time
Description	Change from baseline in HbA1c level over 96 weeks in placebo and treatment group. The treatment group was treated with EGT0001442 for 24 weeks.
Time Frame	Baseline and up to 96 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	EGT0001442	Placebo
Arm/Group Description:	EGT0001442 capsule, 20 mg, orally once daily	Placebo capsule, orally once daily
Overall Number of Participants Analyzed	136	128
Least Squares Mean (Standard Error); Unit of Measure: percentage glycated hemoglobin
Week 2	-0.10 (0.083)	0.22 (0.084)
Week 6	-0.11 (0.137)	0.49 (0.141)
Week 12	-0.19 (0.180)	0.53 (0.186)
Week 18	-0.28 (0.195)	0.43 (0.201)
Week 24	-0.28 (0.194)	0.51 (0.200)
Week 36	-0.52 (0.202)	0.42 (0.209)
Week 48	-0.45 (0.215)	0.54 (0.222)
Week 60	-0.57 (0.219)	0.41 (0.226)
Week 72	-0.43 (0.213)	0.50 (0.220)
Week 84	-0.60 (0.218)	0.38 (0.225)
Week 96	-0.48 (0.215)	0.54 (0.222)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.42 to -0.21
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 6
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -0.78 to -0.41
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.72
	Confidence Interval	(2-Sided) 95%; -0.96 to -0.48
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 18
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.71
	Confidence Interval	(2-Sided) 95%; -0.97 to -0.44
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.79
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.53
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 36
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.93
	Confidence Interval	(2-Sided) 95%; -1.21 to -0.66
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 48
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.99
	Confidence Interval	(2-Sided) 95%; -1.28 to -0.70
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 60
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.98
	Confidence Interval	(2-Sided) 95%; -1.27 to -0.68
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 72
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.93
	Confidence Interval	(2-Sided) 95%; -1.22 to -0.64
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 84
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-0.98
	Confidence Interval	(2-Sided) 95%; -1.27 to -0.69
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Change from baseline in HbA1c (%) at Week 96
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-1.02
	Confidence Interval	(2-Sided) 95%; -1.31 to -0.73
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Change From Baseline Over Time in Fasting Plasma Glucose (FPG)
Description	Changes from baseline in FPG in placebo and treatment group over 24 weeks of treatment
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Only included number of subjects with a value at baseline and at the specified visit

Arm/Group Title		EGT0001442	Placebo
Arm/Group Description:		EGT0001442 capsule, 20 mg, orally once daily	Placebo capsule, 20 mg, orally once daily
Overall Number of Participants Analyzed		145	138
Least Squares Mean (Standard Error); Unit of Measure: mmol/L
Week 2	Number Analyzed	138 participants	127 participants
		-1.39 (0.407)	0.85 (0.422)
Week 6	Number Analyzed	139 participants	131 participants
		-1.23 (0.482)	1.22 (0.499)
Week 12	Number Analyzed	140 participants	131 participants
		-1.75 (0.489)	0.67 (0.507)
Week 18	Number Analyzed	140 participants	131 participants
		-1.87 (0.451)	0.83 (0.467)
Week 24	Number Analyzed	140 participants	131 participants
		-1.74 (0.462)	0.89 (0.478)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 2, between EGT0001442 and Placebo group.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a two-sided t-test for the difference in means of change from baseline
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-2.24
	Confidence Interval	(2-Sided) 95%; -2.79 to -1.70
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 6, between EGT0001442 and Placebo group.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a two-sided t-test for the difference in means of change from baseline
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-2.45
	Confidence Interval	(2-Sided) 95%; -3.09 to -1.81
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 12, between EGT0001442 and Placebo group.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a two-sided t-test for the difference in means of change from baseline
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-2.42
	Confidence Interval	(2-Sided) 95%; -3.06 to -1.77
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 18, between EGT0001442 and Placebo group.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a two-sided t-test for the difference in means of change from baseline.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-2.71
	Confidence Interval	(2-Sided) 95%; -3.30 to -2.11
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	EGT0001442, Placebo
	Comments	Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 24, between EGT0001442 and Placebo group.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	The p-value is from a two-sided t-test for the difference in means of change from baseline.
	Method	ANCOVA
	Comments	Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race
Method of Estimation	Estimation Parameter	Difference of LS Means
	Estimated Value	-2.63
	Confidence Interval	(2-Sided) 95%; -3.24 to -2.02
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Percentage of Subjects Achieving HbA1c <7%
Description	The number and percentage of subjects achieving HbA1c response levels <7% for the FAS using LOCF is reported
Time Frame	Baseline and up to 96 weeks

Outcome Measure Data

Analysis Population Description

Only included number of subjects with a value at baseline and at the specified visit

Arm/Group Title		EGT0001442	Placebo
Arm/Group Description:		EGT0001442 capsule, 20 mg, orally once daily	Placebo capsule, orally once daily
Overall Number of Participants Analyzed		145	138
Measure Type: Count of Participants; Unit of Measure: Participants
Week 2	Number Analyzed	136 participants	128 participants
		14 10.3%	13 10.2%
Week 6	Number Analyzed	139 participants	131 participants
		22 15.8%	15 11.5%
Week 12	Number Analyzed	140 participants	131 participants
		27 19.3%	17 13.0%
Week 18	Number Analyzed	140 participants	131 participants
		29 20.7%	14 10.7%
Week 24	Number Analyzed	140 participants	131 participants
		33 23.6%	14 10.7%
Week 36	Number Analyzed	140 participants	131 participants
		35 25.0%	14 10.7%
Week 48	Number Analyzed	140 participants	131 participants
		41 29.3%	20 15.3%
Week 60	Number Analyzed	140 participants	131 participants
		39 27.9%	18 13.7%
Week 72	Number Analyzed	140 participants	131 participants
		39 27.9%	17 13.0%
Week 84	Number Analyzed	140 participants	131 participants
		43 30.7%	16 12.2%
Week 96	Number Analyzed	140 participants	131 participants
		44 31.4%	14 10.7%

Adverse Events

Time Frame	The adverse event data were collected from Week 0 (Visit 3) up to Week 97 (Visit 15, 1 week follow-up after completion of study).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	EGT0001442	Placebo
Arm/Group Description	EGT0001442 capsule, 20 mg, orally once daily	Placebo capsule, 20 mg, orally once daily
All-Cause Mortality
	EGT0001442	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/145 (0.69%)	0/141 (0.00%)
Serious Adverse Events
	EGT0001442	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/145 (2.07%)	12/141 (8.51%)
Cardiac disorders
Cardiac arrest †	1/145 (0.69%)	0/141 (0.00%)
Tachycardia †	0/145 (0.00%)	1/141 (0.71%)
Hypertensive crisis †	0/145 (0.00%)	1/141 (0.71%)
Gastrointestinal disorders
Diverticulitis †	1/145 (0.69%)	0/141 (0.00%)
Infections and infestations
Pneumonia †	0/145 (0.00%)	1/141 (0.71%)
Urinary tract infection †	0/145 (0.00%)	1/141 (0.71%)
Cellulitis †	2/145 (1.38%)	0/141 (0.00%)
Herpes zoster †	0/145 (0.00%)	1/141 (0.71%)
Injury, poisoning and procedural complications
Wrist fracture †	1/145 (0.69%)	0/141 (0.00%)
Patella fracture †	0/145 (0.00%)	1/141 (0.71%)
Musculoskeletal and connective tissue disorders
Osteoarthritis †	0/145 (0.00%)	1/141 (0.71%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma †	1/145 (0.69%)	0/141 (0.00%)
Tonsil cancer †	0/145 (0.00%)	1/141 (0.71%)
Nervous system disorders
Spinal column stenosis †	0/145 (0.00%)	1/141 (0.71%)
Peripheral nerve lesion †	0/145 (0.00%)	1/141 (0.71%)
Acute polyneuropathy †	0/145 (0.00%)	1/141 (0.71%)
Lumbar spinal stenosis †	0/145 (0.00%)	1/141 (0.71%)
Respiratory, thoracic and mediastinal disorders
Respiratory disorder †	0/145 (0.00%)	1/141 (0.71%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	EGT0001442	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	50/145 (34.48%)	62/141 (43.97%)
Infections and infestations
Urinary Tract Infection †	17/145 (11.72%)	28/141 (19.86%)
Metabolism and nutrition disorders
Hypoglycemia †	24/145 (16.55%)	24/141 (17.02%)
Dyslipidaemia †	5/145 (3.45%)	8/141 (5.67%)
Hypertriglyceridaemia †	5/145 (3.45%)	8/141 (5.67%)
Nervous system disorders
Headache †	7/145 (4.83%)	9/141 (6.38%)
† 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.

The PI is not allowed to publish trial results.

Results Point of Contact

• Name/Title: Albert Collinson, Ph.D.
• Organization: Theracos Sub, LLC
• Phone: (508) 688-4221
• EMail: acollinson@theracos.com

Publications:

American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care. 2011 Jan;34 Suppl 1(Suppl 1):S11-61. doi: 10.2337/dc11-S011. No abstract available.

Ehrenkranz JR, Lewis NG, Kahn CR, Roth J. Phlorizin: a review. Diabetes Metab Res Rev. 2005 Jan-Feb;21(1):31-8. doi: 10.1002/dmrr.532.

Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010 Oct;33(10):2217-24. doi: 10.2337/dc10-0612. Epub 2010 Jun 21.

Han S, Hagan DL, Taylor JR, Xin L, Meng W, Biller SA, Wetterau JR, Washburn WN, Whaley JM. Dapagliflozin, a selective SGLT2 inhibitor, improves glucose homeostasis in normal and diabetic rats. Diabetes. 2008 Jun;57(6):1723-9. doi: 10.2337/db07-1472. Epub 2008 Mar 20.

Komoroski B, Vachharajani N, Boulton D, Kornhauser D, Geraldes M, Li L, Pfister M. Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent glucosuria in healthy subjects. Clin Pharmacol Ther. 2009 May;85(5):520-6. doi: 10.1038/clpt.2008.251. Epub 2009 Jan 7.

Komoroski B, Vachharajani N, Feng Y, Li L, Kornhauser D, Pfister M. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009 May;85(5):513-9. doi: 10.1038/clpt.2008.250. Epub 2009 Jan 7. Erratum In: Clin Pharmacol Ther. 2009 May;85(5):558.

Neumiller JJ, White JR Jr, Campbell RK. Sodium-glucose co-transport inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Drugs. 2010 Mar 5;70(4):377-85. doi: 10.2165/11318680-000000000-00000.

Santer R, Kinner M, Lassen CL, Schneppenheim R, Eggert P, Bald M, Brodehl J, Daschner M, Ehrich JH, Kemper M, Li Volti S, Neuhaus T, Skovby F, Swift PG, Schaub J, Klaerke D. Molecular analysis of the SGLT2 gene in patients with renal glucosuria. J Am Soc Nephrol. 2003 Nov;14(11):2873-82. doi: 10.1097/01.asn.0000092790.89332.d2.

Sicree, R., Shaw, J., and Zimmet, P. (2010). The Global Burden - Diabetes and Impaired Glucose Tolerance (Baker IDI Heart and Diabetes Institute).

van den Heuvel LP, Assink K, Willemsen M, Monnens L. Autosomal recessive renal glucosuria attributable to a mutation in the sodium glucose cotransporter (SGLT2). Hum Genet. 2002 Dec;111(6):544-7. doi: 10.1007/s00439-002-0820-5. Epub 2002 Sep 27.

• Responsible Party: Theracos
• ClinicalTrials.gov Identifier: NCT01377844
• Other Study ID Numbers: THR-1442-C-418
• First Submitted: June 13, 2011
• First Posted: June 21, 2011
• Results First Submitted: May 21, 2021
• Results First Posted: June 16, 2021
• Last Update Posted: July 1, 2021