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Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01029704
Recruitment Status : Completed
First Posted : December 10, 2009
Results First Posted : July 20, 2011
Last Update Posted : August 7, 2013
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 Diabetes Mellitus Type 2
Interventions Drug: EGT0001442
Drug: Placebo capsules to match EGT0001442
Enrollment 129
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg
Hide Arm/Group Description Received no drug (EGT0001442) during 28 days Received 5mg of EGT0001442 per day for 28 days Received 10mg of EGT0001442 per day for 28 days Received 20mg of EGT0001442 per day for 28 days Received 50mg of EGT0001442 per day for 28 days
Period Title: Overall Study
Started 28 24 23 28 26
Completed 28 24 23 28 26
Not Completed 0 0 0 0 0
Arm/Group Title Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg Total
Hide Arm/Group Description Received no drug (EGT0001442) during 28 days Received 5mg of EGT0001442 per day for 28 days Received 10mg of EGT0001442 per day for 28 days Received 20mg of EGT0001442 per day for 28 days Received 50mg of EGT0001442 per day for 28 days Total of all reporting groups
Overall Number of Baseline Participants 28 24 23 28 26 129
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 24 participants 23 participants 28 participants 26 participants 129 participants
58.7  (7.3) 57.8  (6.9) 54.9  (9) 59  (7.1) 54.7  (6.7) 57.1  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 23 participants 28 participants 26 participants 129 participants
Female
11
  39.3%
9
  37.5%
12
  52.2%
12
  42.9%
18
  69.2%
62
  48.1%
Male
17
  60.7%
15
  62.5%
11
  47.8%
16
  57.1%
8
  30.8%
67
  51.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 24 participants 23 participants 28 participants 26 participants 129 participants
Hispanic or Latino
20
  71.4%
16
  66.7%
15
  65.2%
19
  67.9%
19
  73.1%
89
  69.0%
Not Hispanic or Latino
8
  28.6%
8
  33.3%
8
  34.8%
9
  32.1%
7
  26.9%
40
  31.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Changes From the Baseline in the Fasting Plasma Glucose at End of 28 Days
Hide Description Fasting glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the fasting plasma glucose level during the study period was calculated by reducing the baseline glucose level (day 1) from glucose level at end of treatment (day 28) (i.e glucose level on day 28 minus glucose level on Day 1).
Time Frame baseline (day 1) and 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg
Hide Arm/Group Description:
Received no drug (EGT0001442) during 28 days
Received 5mg of EGT0001442 per day for 28 days
Received 10mg of EGT0001442 per day for 28 days
Received 20mg of EGT0001442 per day for 28 days
Received 50mg of EGT0001442 per day for 28 days
Overall Number of Participants Analyzed 28 24 23 28 26
Mean (Standard Deviation)
Unit of Measure: mg/dL
-6.63  (33.51) -24.25  (41.03) -29  (38.3) -36.14  (47.13) -41.64  (41.95)
2.Secondary Outcome
Title Change From the Baseline in the Body Weight at End of 28 Days
Hide Description Body weight was measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the body weight during the study period was calculated by reducing the baseline body weight (day 1) from body weight at end of treatment (day 28) (i.e body weight on day 28 minus body weight on Day 1).
Time Frame baseline (day 1) and 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg
Hide Arm/Group Description:
Received no drug (EGT0001442) during 28 days
Received 5mg of EGT0001442 per day for 28 days
Received 10mg of EGT0001442 per day for 28 days
Received 20mg of EGT0001442 per day for 28 days
Received 50mg of EGT0001442 per day for 28 days
Overall Number of Participants Analyzed 28 24 23 28 26
Mean (Standard Deviation)
Unit of Measure: Kg
0.16  (1.5) -0.76  (1.8) -0.64  (1.26) -1.64  (1.22) -1.74  (1.60)
3.Secondary Outcome
Title Changes From the Baseline in the Hemoglobin A1c (HbA1c) at End of 28 Days
Hide Description HbA1c levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the HbA1c level during the study period was calculated by reducing the baseline HbA1c level (day 1) from HbA1c level at end of treatment (day 28) (i.e HbA1c level on day 28 minus HbA1c level on Day 1).
Time Frame baseline (day 1) and 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg
Hide Arm/Group Description:
Received no drug (EGT0001442) during 28 days
Received 5mg of EGT0001442 per day for 28 days
Received 10mg of EGT0001442 per day for 28 days
Received 20mg of EGT0001442 per day for 28 days
Received 50mg of EGT0001442 per day for 28 days
Overall Number of Participants Analyzed 28 24 23 28 26
Mean (Standard Deviation)
Unit of Measure: Percent
0.2  (0.59) -0.21  (0.49) 0.02  (0.41) 0.19  (0.52) -0.2  (0.5)
4.Secondary Outcome
Title Changes From the Baseline in the Urinary Glucose Excretion at End of 28 Days
Hide Description Urinary glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (day 1) from urinary glucose level at end of treatment (day 28) (i.e urinary glucose level on day 28 minus urinary glucose level on Day 1).
Time Frame baseline (day 1) and 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg
Hide Arm/Group Description:
Received no drug (EGT0001442) during 28 days
Received 5mg of EGT0001442 per day for 28 days
Received 10mg of EGT0001442 per day for 28 days
Received 20mg of EGT0001442 per day for 28 days
Received 50mg of EGT0001442 per day for 28 days
Overall Number of Participants Analyzed 28 22 19 25 25
Mean (Standard Deviation)
Unit of Measure: g/24h
0.2  (14.98) 22.57  (16.56) 18.71  (20.46) 21.01  (16.43) 26.8  (19.36)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg
Hide Arm/Group Description Received no drug (EGT0001442) during 28 days Received 5mg of EGT0001442 per day for 28 days Received 10mg of EGT0001442 per day for 28 days Received 20mg of EGT0001442 per day for 28 days Received 50mg of EGT0001442 per day for 28 days
All-Cause Mortality
Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo EGT0001442 5mg EGT0001442 10mg EGT0001442 20mg EGT0001442 50mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Yuan-Di C. Halvorsen, PhD
Organization: Theracos, Inc.
Phone: 617-726-4236
Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT01029704     History of Changes
Other Study ID Numbers: THR-1442-C-402
First Submitted: December 9, 2009
First Posted: December 10, 2009
Results First Submitted: June 21, 2011
Results First Posted: July 20, 2011
Last Update Posted: August 7, 2013