Trial Outcomes & Findings for Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus (NCT NCT01377844)

NCT ID: NCT01377844

Last Updated: 2021-07-01

Results Overview

Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 288 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2021-07-01

Participant Flow

Participant milestones

Measure	EGT0001442 EGT0001442 capsule, 20 mg, orally once daily	Placebo Placebo capsule, orally once daily
Overall Study STARTED	145	143
Overall Study Safety Population	145	141
Overall Study COMPLETED	109	108
Overall Study NOT COMPLETED	36	35

Reasons for withdrawal

Measure	EGT0001442 EGT0001442 capsule, 20 mg, orally once daily	Placebo Placebo capsule, orally once daily
Overall Study Withdrawal by Subject	25	28
Overall Study Protocol Violation	2	3
Overall Study Adverse Event	3	0
Overall Study Physician Decision	6	3
Overall Study Study terminated by Sponsor	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	EGT0001442 n=145 Participants EGT0001442 capsule, 20 mg, orally once daily	Placebo n=141 Participants Placebo capsule, 20 mg, orally once daily	Total n=286 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 10.94 • n=5 Participants	54.7 years STANDARD_DEVIATION 10.30 • n=7 Participants	55.4 years STANDARD_DEVIATION 10.64 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	91 Participants n=7 Participants	169 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	50 Participants n=7 Participants	117 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	129 Participants n=5 Participants	125 Participants n=7 Participants	254 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants	112 Participants n=7 Participants	222 Participants n=5 Participants
Race (NIH/OMB) More than one race	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index	29.7 kg/m2 STANDARD_DEVIATION 5.35 • n=5 Participants	30.6 kg/m2 STANDARD_DEVIATION 5.41 • n=7 Participants	30.1 kg/m2 STANDARD_DEVIATION 5.39 • n=5 Participants
Baseline HbA1c Category < 8.5%	87 Participants n=5 Participants	100 Participants n=7 Participants	187 Participants n=5 Participants
Baseline HbA1c Category > 8.5%	58 Participants n=5 Participants	41 Participants n=7 Participants	99 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

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

Changes from baseline in HbA1c in placebo and treatment group at end of 24 weeks treatment

Outcome measures

Measure	EGT0001442 n=140 Participants EGT0001442 capsule, 20 mg, orally once daily	Placebo n=131 Participants Placebo capsule, orally once daily
Change From Baseline in Hemoglobin A1c at 24 Weeks	-0.28 percentage of glycated hemoglobin Standard Error 0.194	0.51 percentage of glycated hemoglobin Standard Error 0.200

SECONDARY outcome

Timeframe: Baseline and Week 24

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

Changes from baseline in systolic and diastolic blood pressure in placebo and treatment group after 24 weeks of treatment

Outcome measures

Measure	EGT0001442 n=140 Participants EGT0001442 capsule, 20 mg, orally once daily	Placebo n=131 Participants Placebo capsule, orally once daily
Changes in Systolic and Diastolic Blood Pressure at Week 24 Systolic blood pressure	-8.62 mm Hg Standard Error 1.903	-3.08 mm Hg Standard Error 1.964
Changes in Systolic and Diastolic Blood Pressure at Week 24 Diastolic blood pressure	-3.07 mm Hg Standard Error 1.223	-0.40 mm Hg Standard Error 1.275

SECONDARY outcome

Timeframe: Baseline and week 24

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

Changes from baseline in body weight in placebo and treatment group after 24 weeks of treatment

Outcome measures

Measure	EGT0001442 n=128 Participants EGT0001442 capsule, 20 mg, orally once daily	Placebo n=104 Participants Placebo capsule, orally once daily
Changes in Body Weight at Week 24	-2.95 kg Standard Error 0.555	-1.22 kg Standard Error 0.592

SECONDARY outcome

Timeframe: Baseline and up to 96 weeks

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

Change from baseline in HbA1c level over 96 weeks in placebo and treatment group. The treatment group was treated with EGT0001442 for 24 weeks.

Outcome measures

Measure	EGT0001442 n=136 Participants EGT0001442 capsule, 20 mg, orally once daily	Placebo n=128 Participants Placebo capsule, orally once daily
Change From Baseline in HbA1c Over 96 Weeks Time Week 6	-0.11 percentage glycated hemoglobin Standard Error 0.137	0.49 percentage glycated hemoglobin Standard Error 0.141
Change From Baseline in HbA1c Over 96 Weeks Time Week 12	-0.19 percentage glycated hemoglobin Standard Error 0.180	0.53 percentage glycated hemoglobin Standard Error 0.186
Change From Baseline in HbA1c Over 96 Weeks Time Week 60	-0.57 percentage glycated hemoglobin Standard Error 0.219	0.41 percentage glycated hemoglobin Standard Error 0.226
Change From Baseline in HbA1c Over 96 Weeks Time Week 72	-0.43 percentage glycated hemoglobin Standard Error 0.213	0.50 percentage glycated hemoglobin Standard Error 0.220
Change From Baseline in HbA1c Over 96 Weeks Time Week 84	-0.60 percentage glycated hemoglobin Standard Error 0.218	0.38 percentage glycated hemoglobin Standard Error 0.225
Change From Baseline in HbA1c Over 96 Weeks Time Week 2	-0.10 percentage glycated hemoglobin Standard Error 0.083	0.22 percentage glycated hemoglobin Standard Error 0.084
Change From Baseline in HbA1c Over 96 Weeks Time Week 18	-0.28 percentage glycated hemoglobin Standard Error 0.195	0.43 percentage glycated hemoglobin Standard Error 0.201
Change From Baseline in HbA1c Over 96 Weeks Time Week 24	-0.28 percentage glycated hemoglobin Standard Error 0.194	0.51 percentage glycated hemoglobin Standard Error 0.200
Change From Baseline in HbA1c Over 96 Weeks Time Week 36	-0.52 percentage glycated hemoglobin Standard Error 0.202	0.42 percentage glycated hemoglobin Standard Error 0.209
Change From Baseline in HbA1c Over 96 Weeks Time Week 48	-0.45 percentage glycated hemoglobin Standard Error 0.215	0.54 percentage glycated hemoglobin Standard Error 0.222
Change From Baseline in HbA1c Over 96 Weeks Time Week 96	-0.48 percentage glycated hemoglobin Standard Error 0.215	0.54 percentage glycated hemoglobin Standard Error 0.222

SECONDARY outcome

Timeframe: 24 weeks

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

Changes from baseline in FPG in placebo and treatment group over 24 weeks of treatment

Outcome measures

Measure	EGT0001442 n=145 Participants EGT0001442 capsule, 20 mg, orally once daily	Placebo n=138 Participants Placebo capsule, orally once daily
Change From Baseline Over Time in Fasting Plasma Glucose (FPG) Week 2	-1.39 mmol/L Standard Error 0.407	0.85 mmol/L Standard Error 0.422
Change From Baseline Over Time in Fasting Plasma Glucose (FPG) Week 6	-1.23 mmol/L Standard Error 0.482	1.22 mmol/L Standard Error 0.499
Change From Baseline Over Time in Fasting Plasma Glucose (FPG) Week 12	-1.75 mmol/L Standard Error 0.489	0.67 mmol/L Standard Error 0.507
Change From Baseline Over Time in Fasting Plasma Glucose (FPG) Week 18	-1.87 mmol/L Standard Error 0.451	0.83 mmol/L Standard Error 0.467
Change From Baseline Over Time in Fasting Plasma Glucose (FPG) Week 24	-1.74 mmol/L Standard Error 0.462	0.89 mmol/L Standard Error 0.478

SECONDARY outcome

Timeframe: Baseline and up to 96 weeks

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

The number and percentage of subjects achieving HbA1c response levels <7% for the FAS using LOCF is reported

Outcome measures

Measure	EGT0001442 n=145 Participants EGT0001442 capsule, 20 mg, orally once daily	Placebo n=138 Participants Placebo capsule, orally once daily
Percentage of Subjects Achieving HbA1c <7% Week 36	35 Participants	14 Participants
Percentage of Subjects Achieving HbA1c <7% Week 2	14 Participants	13 Participants
Percentage of Subjects Achieving HbA1c <7% Week 6	22 Participants	15 Participants
Percentage of Subjects Achieving HbA1c <7% Week 12	27 Participants	17 Participants
Percentage of Subjects Achieving HbA1c <7% Week 18	29 Participants	14 Participants
Percentage of Subjects Achieving HbA1c <7% Week 24	33 Participants	14 Participants
Percentage of Subjects Achieving HbA1c <7% Week 48	41 Participants	20 Participants
Percentage of Subjects Achieving HbA1c <7% Week 60	39 Participants	18 Participants
Percentage of Subjects Achieving HbA1c <7% Week 72	39 Participants	17 Participants
Percentage of Subjects Achieving HbA1c <7% Week 84	43 Participants	16 Participants
Percentage of Subjects Achieving HbA1c <7% Week 96	44 Participants	14 Participants

Adverse Events

EGT0001442

Serious events: 3 serious events

Other events: 50 other events

Deaths: 1 deaths

Placebo

Serious events: 12 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	EGT0001442 n=145 participants at risk EGT0001442 capsule, 20 mg, orally once daily	Placebo n=141 participants at risk Placebo capsule, 20 mg, orally once daily
Cardiac disorders Cardiac arrest	0.69% 1/145 • 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).	0.00% 0/141 • 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).
Cardiac disorders Tachycardia	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Cardiac disorders Hypertensive crisis	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Infections and infestations Pneumonia	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Infections and infestations Urinary tract infection	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Infections and infestations Cellulitis	1.4% 2/145 • 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).	0.00% 0/141 • 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).
Gastrointestinal disorders Diverticulitis	0.69% 1/145 • 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).	0.00% 0/141 • 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).
Infections and infestations Herpes zoster	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.69% 1/145 • 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).	0.00% 0/141 • 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Nervous system disorders Spinal column stenosis	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Nervous system disorders Peripheral nerve lesion	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Nervous system disorders Acute polyneuropathy	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Nervous system disorders Lumbar spinal stenosis	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Injury, poisoning and procedural complications Wrist fracture	0.69% 1/145 • 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).	0.00% 0/141 • 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).
Injury, poisoning and procedural complications Patella fracture	0.00% 0/145 • 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).	0.71% 1/141 • 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).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/145 • 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).	0.71% 1/141 • 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).

Other adverse events

Measure	EGT0001442 n=145 participants at risk EGT0001442 capsule, 20 mg, orally once daily	Placebo n=141 participants at risk Placebo capsule, 20 mg, orally once daily
Metabolism and nutrition disorders Hypoglycemia	16.6% 24/145 • 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).	17.0% 24/141 • 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).
Metabolism and nutrition disorders Dyslipidaemia	3.4% 5/145 • 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).	5.7% 8/141 • 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).
Metabolism and nutrition disorders Hypertriglyceridaemia	3.4% 5/145 • 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).	5.7% 8/141 • 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).
Infections and infestations Urinary Tract Infection	11.7% 17/145 • 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).	19.9% 28/141 • 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).
Nervous system disorders Headache	4.8% 7/145 • 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).	6.4% 9/141 • 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).

Additional Information

Albert Collinson, Ph.D.

Theracos Sub, LLC

Phone: (508) 688-4221

Email: acollinson@theracos.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI is not allowed to publish trial results.
• Publication restrictions are in place

Restriction type: OTHER