Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus
Sponsor
Theracos (Industry)
Overall Status
Completed
CT.gov ID
NCT01029704
Collaborator
(none)
151
12
2
7
12.6
1.8
Study Details
Study Description
Brief Summary
The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes.
The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This was a phase 2 study to evaluate the efficacy of
EGT0001442. The study included two segments:
Segment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic subjects per group who received 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. The subjects were in clinic for the first 3 days for safety and PK evaluation.
Segment 2 was a multi-center, double-blind, placebo-controlled parallel group study. One hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects per group were randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day or placebo once daily for 28 days in an outpatient setting.
Study Design
Study Type:
Interventional
Actual Enrollment
:
151 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase II, Four-week, Multi-center, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Safety and Efficacy of EGT0001442 in Subjects With Type 2 Diabetes Mellitus With an Ascending Dose Safety and Pharmacokinetic Evaluation Period
Actual Study Start Date
:
Dec 1, 2009
Actual Primary Completion Date
:
Jul 1, 2010
Actual Study Completion Date
:
Jul 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EGT0001442
|
Drug: EGT0001442
Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.
Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.
Other Names:
|
| Placebo Comparator: Placebo
|
Drug: Placebo capsules to match EGT0001442
Segment 1: Not applicable.
Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study [Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29]
Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.
- Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4 [Pre-dose to 48 h post-dose]
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
- Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 [Pre-dose to 48 h post-dose]
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
Secondary Outcome Measures
- Change in the Body Weight From Baseline at Week 4 [Baseline and Day 29]
Changes in the body weight during the study period was calculated by subtracting body weight on day 1 from body weight at the end of treatment on day 29.
- Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4 [Baseline and Day 29]
HbA1c levels were measured at two time points; on day 1 and day 29 (end of treatment). Changes in the HbA1c level during the study period was calculated by subtracting HbA1c level on day 1 from HbA1c level at the end of treatment (day 29)
- Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 [Baseline, Day 1 and Day 28]
Urinary glucose levels were measured at three time points; on Day 0 (baseline), Day 1 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).
- Change in FPG Following Cessation of Treatment [Days 27/29 to Days 41/43]
The mean change in FPG following cessation of treatment was obtained by calculating the difference between FPG values obtained on End of treatment (average of FPG values on days 27 and 29) and on Post Treatment (average of FPG values on days 41 and 43).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
-
Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).
-
HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.
-
Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.
-
Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).
-
If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
-
Female subjects must be surgically sterilized or postmenopausal.
Exclusion Criteria:
-
Type 1 diabetes or diabetes treated with insulin injection.
-
Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
-
Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.
-
Positive results on screen for drugs of abuse.
-
Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
-
Previous treatment with EGT0001474 or EGT0001442.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site #10 | Birmingham | Alabama | United States | |
| 2 | Research Site #04 | National City | California | United States | |
| 3 | Research Site #12 | Denver | Colorado | United States | |
| 4 | Research Site #07 | Miami | Florida | United States | |
| 5 | Research Site #08 | Miami | Florida | United States | |
| 6 | Research Site #06 | Reading | Pennsylvania | United States | |
| 7 | Research Site #11 | DeSoto | Texas | United States | |
| 8 | Research Site #01 | San Antonio | Texas | United States | |
| 9 | Research Site #15 | San Antonio | Texas | United States | |
| 10 | Research Site #03 | Brampton | Ontario | Canada | |
| 11 | Research Site #13 | London | Ontario | Canada | |
| 12 | Research Site #02 | Mississauga | Ontario | Canada |
Sponsors and Collaborators
- Theracos
Investigators
- Study Chair: Mason W Freeman, M.D., Massachusetts General Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Theracos
ClinicalTrials.gov Identifier:
NCT01029704
Other Study ID Numbers:
- THR-1442-C-402
First Posted:
Dec 10, 2009
Last Update Posted:
Jun 16, 2021
Last Verified:
Jun 1, 2021
Keywords provided by Theracos
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Segment 1 (Dose Escalation): EGT0001442 5mg | Segment 1 (Dose Escalation): EGT0001442 10mg | Segment 1 (Dose Escalation): EGT0001442 20mg | Segment 1 (Dose Escalation): EGT0001442 50mg | Segment 2 (Double-blind): Placebo | Segment 2 (Double-blind): EGT0001442 5mg | Segment 2 (Double-blind): EGT0001442 10mg | Segment 2 (Double-blind): EGT0001442 20mg | Segment 2 (Double-blind): EGT0001442 50mg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Received 5mg of EGT0001442 once daily for 28 days | Received 10mg of EGT0001442 once daily for 28 days | Received 20mg of EGT0001442 once daily for 28 days | Received 50mg of EGT0001442 once daily for 28 days | Received placebo once daily for 28 days | Received 5mg of EGT0001442 once daily for 28 days | Received 10mg of EGT0001442 once daily for 28 days | Received 20mg of EGT0001442 once daily for 28 days | Received 50mg of EGT0001442 once daily for 28 days |
| Period Title: Overall Study | |||||||||
| STARTED | 5 | 5 | 5 | 5 | 28 | 24 | 23 | 28 | 26 |
| COMPLETED | 5 | 5 | 5 | 5 | 23 | 20 | 19 | 22 | 25 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 5 | 4 | 4 | 6 | 1 |
Baseline Characteristics
| Arm/Group Title | Segment 1 (Dose Escalation): EGT0001442 5mg | Segment 1 (Dose Escalation): EGT0001442 10mg | Segment 1 (Dose Escalation): EGT0001442 20mg | Segment 1 (Dose Escalation): EGT0001442 50mg | Segment 2 (Double-blind): Placebo | Segment 2 (Double-blind): EGT0001442 5mg | Segment 2 (Double-blind): EGT0001442 10mg | Segment 2 (Double-blind): EGT0001442 20mg | Segment 2 (Double-blind): EGT0001442 50mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Received 5mg of EGT0001442 once daily for 28 days | Received 10mg of EGT0001442 once daily for 28 days | Received 20mg of EGT0001442 once daily for 28 days | Received 50mg of EGT0001442 once daily for 28 days | Received placebo once daily for 28 days | Received 5mg of EGT0001442 once daily for 28 days | Received 10mg of EGT0001442 once daily for 28 days | Received 20mg of EGT0001442 once daily for 28 days | Received 50mg of EGT0001442 once daily for 28 days | Total of all reporting groups |
| Overall Participants | 5 | 5 | 5 | 5 | 28 | 24 | 23 | 28 | 26 | 149 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||
| Segment 1 |
62.2
(7.9)
|
49.4
(14.2)
|
51.4
(11.7)
|
53.2
(5.8)
|
54.1
(10.8)
|
|||||
| Segment 2 |
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 (Count of Participants) | ||||||||||
| Female |
1
20%
|
1
20%
|
3
60%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
6
4%
|
| Male |
4
80%
|
4
80%
|
2
40%
|
4
80%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
14
9.4%
|
| Female |
11
220%
|
9
180%
|
12
240%
|
12
240%
|
18
64.3%
|
62
258.3%
|
||||
| Male |
17
340%
|
15
300%
|
11
220%
|
16
320%
|
8
28.6%
|
67
279.2%
|
||||
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||||
| Hispanic or Latino |
4
80%
|
4
80%
|
3
60%
|
4
80%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
15
10.1%
|
| Not Hispanic or Latino |
1
20%
|
1
20%
|
2
40%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
5
3.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hispanic or Latino |
20
400%
|
16
320%
|
15
300%
|
19
380%
|
19
67.9%
|
89
370.8%
|
||||
| Not Hispanic or Latino |
8
160%
|
8
160%
|
8
160%
|
9
180%
|
7
25%
|
40
166.7%
|
||||
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||||
| Race (NIH/OMB) (Count of Participants) | ||||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
1
20%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
1.3%
|
| White |
5
100%
|
5
100%
|
4
80%
|
4
80%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
18
12.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||||
| Asian |
5
100%
|
2
40%
|
3
60%
|
4
80%
|
1
3.6%
|
15
62.5%
|
||||
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||||
| Black or African American |
2
40%
|
2
40%
|
1
20%
|
1
20%
|
0
0%
|
6
25%
|
||||
| White |
21
420%
|
20
400%
|
19
380%
|
22
440%
|
24
85.7%
|
106
441.7%
|
||||
| More than one race |
0
0%
|
0
0%
|
0
0%
|
1
20%
|
1
3.6%
|
2
8.3%
|
||||
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
||||
| Height (cm) [Mean (Standard Deviation) ] | ||||||||||
| Segment 1 |
172.04
(11.49)
|
167.34
(11.42)
|
163.74
(9.10)
|
172.80
(9.00)
|
168.98
(10.20)
|
|||||
| Segment 2 |
167.76
(11.09)
|
170.15
(9.32)
|
167.50
(9.83)
|
166.71
(9.60)
|
164.92
(10.98)
|
167.36
(10.19)
|
||||
| Weight (kg) [Mean (Standard Deviation) ] | ||||||||||
| Segment 1 |
91.04
(14.48)
|
83.72
(9.86)
|
92.18
(16.65)
|
87.22
(12.81)
|
88.54
(13.01)
|
|||||
| Segment 2 |
84.34
(15.83)
|
86.75
(13.53)
|
81.40
(15.03)
|
81.03
(12.17)
|
84.18
(17.61)
|
83.51
(14.86)
|
||||
| BMI (kg/m2) [Mean (Standard Deviation) ] | ||||||||||
| Segment 1 |
30.58
(1.85)
|
30.00
(3.39)
|
34.18
(3.58)
|
29.14
(2.94)
|
30.98
(3.40)
|
|||||
| Segment 2 |
29.77
(3.03)
|
29.96
(3.98)
|
28.91
(4.02)
|
29.10
(3.30)
|
30.75
(4.47)
|
29.70
(3.77)
|
||||
Outcome Measures
| Title | Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study |
|---|---|
| Description | Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG. |
| Time Frame | Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects participated in Segment 2 of the study were included in the analysis. |
| Arm/Group Title | Placebo | EGT0001442 5mg | EGT0001442 10mg | EGT0001442 20mg | EGT0001442 50mg |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 28 | 24 | 23 | 28 | 26 |
| Least Squares Mean (Standard Error) [mg/dL] |
-12.595
(7.025)
|
-29.518
(7.767)
|
-30.429
(8.386)
|
-32.586
(7.305)
|
-44.605
(7.299)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 5mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0989 |
| Comments | P-values are from two-sided test at 5% level | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -16.923 | |
| Confidence Interval |
(2-Sided) 95% -37.076 to 3.230 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 10mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0964 |
| Comments | P-values are from two-sided test at 5% level | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -17.834 | |
| Confidence Interval |
(2-Sided) 95% -38.909 to 3.242 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 20mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0465 |
| Comments | P-values are from two-sided test at 5% level | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -19.991 | |
| Confidence Interval |
(2-Sided) 95% -39.670 to -0.312 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 50mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0015 |
| Comments | P-values are from two-sided test at 5% level | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -32.010 | |
| Confidence Interval |
(2-Sided) 95% -51.487 to -12.533 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4 |
|---|---|
| Description | Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods. |
| Time Frame | Pre-dose to 48 h post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2. |
| Arm/Group Title | Segment 1 (Dose Escalation): EGT0001442 5mg | Segment 1 (Dose Escalation): EGT0001442 10mg | Segment 1 (Dose Escalation): EGT0001442 20mg | Segment 1 (Dose Escalation): EGT0001442 50mg |
|---|---|---|---|---|
| Arm/Group Description | Received 5mg of EGT0001442 once daily for 28 days | Received 10mg of EGT0001442 once daily for 28 days | Received 20mg of EGT0001442 once daily for 28 days | Received 50mg of EGT0001442 once daily for 28 days |
| Measure Participants | 5 | 5 | 5 | 5 |
| Mean (Standard Deviation) [ng/mL] |
40.42
(15.21)
|
83.38
(30.93)
|
164.20
(40.21)
|
541.20
(192.20)
|
| Title | Change in the Body Weight From Baseline at Week 4 |
|---|---|
| Description | Changes in the body weight during the study period was calculated by subtracting body weight on day 1 from body weight at the end of treatment on day 29. |
| Time Frame | Baseline and Day 29 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects participated in Segment 2 of the study were included in the analysis. |
| Arm/Group Title | Placebo | EGT0001442 5mg | EGT0001442 10mg | EGT0001442 20mg | EGT0001442 50mg |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 28 | 24 | 23 | 28 | 26 |
| Least Squares Mean (Standard Error) [Kg] |
0.258
(0.304)
|
-1.176
(0.345)
|
-0.779
(0.346)
|
-1.796
(0.324)
|
-0.914
(0.315)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 5mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0025 |
| Comments | P-values are from a two-sided test. | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -1.434 | |
| Confidence Interval |
(2-Sided) 95% -2.349 to -0.520 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 10mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0269 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -1.037 | |
| Confidence Interval |
(2-Sided) 95% -1.952 to -0.122 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 20mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -2.054 | |
| Confidence Interval |
(2-Sided) 95% -2.938 to -1.170 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 50mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0090 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -1.172 | |
| Confidence Interval |
(2-Sided) 95% -2.044 to -0.301 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4 |
|---|---|
| Description | HbA1c levels were measured at two time points; on day 1 and day 29 (end of treatment). Changes in the HbA1c level during the study period was calculated by subtracting HbA1c level on day 1 from HbA1c level at the end of treatment (day 29) |
| Time Frame | Baseline and Day 29 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects participated in Segment 2 of the study were included in the analysis. |
| Arm/Group Title | Placebo | EGT0001442 5mg | EGT0001442 10mg | EGT0001442 20mg | EGT0001442 50mg |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 28 | 24 | 23 | 28 | 26 |
| Geometric Least Squares Mean (Standard Error) [percentage of HbA1c] |
0.178
(0.107)
|
-0.176
(0.122)
|
0.022
(0.123)
|
0.173
(0.115)
|
-0.167
(0.112)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 5mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0281 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -0.353 | |
| Confidence Interval |
(2-Sided) 95% -0.668 to -0.039 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 10mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3215 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -0.155 | |
| Confidence Interval |
(2-Sided) 95% -0.464 to 0.154 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 20mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9776 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -0.004 | |
| Confidence Interval |
(2-Sided) 95% -0.304 to 0.295 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 50mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0242 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | -0.344 | |
| Confidence Interval |
(2-Sided) 95% -0.642 to -0.046 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28 |
|---|---|
| Description | Urinary glucose levels were measured at three time points; on Day 0 (baseline), Day 1 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 Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only number of subjects with data available in the specific treatment group is included |
| Arm/Group Title | Placebo | EGT0001442 5mg | EGT0001442 10mg | EGT0001442 20mg | EGT0001442 50mg |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 28 | 23 | 22 | 28 | 26 |
| Change in 24 h UGE from baseline to Day 1 |
-3.55
(13.05)
|
26.21
(11.08)
|
24.17
(16.89)
|
25.13
(12.72)
|
29.61
(20.00)
|
| Change in 24 h UGE from baseline to Day 28 |
-0.20
(14.98)
|
22.57
(16.56)
|
18.71
(20.46)
|
21.01
(16.43)
|
26.80
(19.36)
|
| Title | Change in FPG Following Cessation of Treatment |
|---|---|
| Description | The mean change in FPG following cessation of treatment was obtained by calculating the difference between FPG values obtained on End of treatment (average of FPG values on days 27 and 29) and on Post Treatment (average of FPG values on days 41 and 43). |
| Time Frame | Days 27/29 to Days 41/43 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects participated in Segment 2 of the study and had fasting plasma glucose (FPG) values at the end of treatment (mean FPG value on days 27 and 29) and at post-treatment (mean FPG values on days 41 and 43) are included in the analysis. |
| Arm/Group Title | Placebo | EGT0001442 5mg | EGT0001442 10mg | EGT0001442 20mg | EGT0001442 50mg |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 26 | 21 | 19 | 21 | 25 |
| Least Squares Mean (Standard Error) [mg/dL] |
0.058
(8.256)
|
17.746
(8.896)
|
17.148
(10.421)
|
24.437
(7.989)
|
20.807
(8.021)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 5mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1613 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | 17.688 | |
| Confidence Interval |
(2-Sided) 95% -7.210 to 42.587 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 10mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2079 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | 17.091 | |
| Confidence Interval |
(2-Sided) 95% -9.696 to 43.877 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 20mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0410 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | 24.379 | |
| Confidence Interval |
(2-Sided) 95% 1.028 to 47.731 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, EGT0001442 50mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0862 |
| Comments | P-values are from a two-sided test | |
| Method | ANCOVA | |
| Comments | Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate. | |
| Method of Estimation | Estimation Parameter | Difference of LS Means |
| Estimated Value | 20.749 | |
| Confidence Interval |
(2-Sided) 95% -3.019 to 44.518 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4 |
|---|---|
| Description | Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods. |
| Time Frame | Pre-dose to 48 h post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2. AUC0-24 values for two participants in 5 mg arm were not calculated. |
| Arm/Group Title | Segment 1 (Dose Escalation): EGT0001442 5mg | Segment 1 (Dose Escalation): EGT0001442 10mg | Segment 1 (Dose Escalation): EGT0001442 20mg | Segment 1 (Dose Escalation): EGT0001442 50mg |
|---|---|---|---|---|
| Arm/Group Description | Received 5mg of EGT0001442 once daily for 28 days | Received 10mg of EGT0001442 once daily for 28 days | Received 20mg of EGT0001442 once daily for 28 days | Received 50mg of EGT0001442 once daily for 28 days |
| Measure Participants | 5 | 5 | 5 | 5 |
| AUC0-t |
334.02
(51.80)
|
681.88
(74.66)
|
1312.36
(487.28)
|
3308.88
(785.59)
|
| AUC0-24 |
328.85
(56.07)
|
548.15
(70.41)
|
1076.39
(373.15)
|
2755.68
(586.08)
|
Adverse Events
| Time Frame | Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||
| Arm/Group Title | Segment 1 (Dose Escalation): EGT0001442 5mg | Segment 1 (Dose Escalation): EGT0001442 10mg | Segment 1 (Dose Escalation): EGT0001442 20mg | Segment 1 (Dose Escalation): EGT0001442 50mg | Placebo | EGT0001442 5mg | EGT0001442 10mg | EGT0001442 20mg | EGT0001442 50mg | |||||||||
| Arm/Group Description | Received 5mg of EGT0001442 once daily for 28 days | Received 10mg of EGT0001442 once daily for 28 days | Received 20mg of EGT0001442 once daily for 28 days | Received 50mg of EGT0001442 once daily for 28 days | 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 |
||||||||||||||||||
| Segment 1 (Dose Escalation): EGT0001442 5mg | Segment 1 (Dose Escalation): EGT0001442 10mg | Segment 1 (Dose Escalation): EGT0001442 20mg | Segment 1 (Dose Escalation): EGT0001442 50mg | Placebo | EGT0001442 5mg | EGT0001442 10mg | EGT0001442 20mg | EGT0001442 50mg | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| Segment 1 (Dose Escalation): EGT0001442 5mg | Segment 1 (Dose Escalation): EGT0001442 10mg | Segment 1 (Dose Escalation): EGT0001442 20mg | Segment 1 (Dose Escalation): EGT0001442 50mg | Placebo | EGT0001442 5mg | EGT0001442 10mg | EGT0001442 20mg | EGT0001442 50mg | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 1/24 (4.2%) | 1/23 (4.3%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||
| Breast cancer | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 1/23 (4.3%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Vascular disorders | ||||||||||||||||||
| Thrombophlebitis superficial | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 1/24 (4.2%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| Segment 1 (Dose Escalation): EGT0001442 5mg | Segment 1 (Dose Escalation): EGT0001442 10mg | Segment 1 (Dose Escalation): EGT0001442 20mg | Segment 1 (Dose Escalation): EGT0001442 50mg | Placebo | EGT0001442 5mg | EGT0001442 10mg | EGT0001442 20mg | EGT0001442 50mg | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/5 (60%) | 3/5 (60%) | 3/5 (60%) | 2/5 (40%) | 4/28 (14.3%) | 3/24 (12.5%) | 6/23 (26.1%) | 6/28 (21.4%) | 6/26 (23.1%) | |||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||
| Leucopenia | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Abdominal pain upper | 1/5 (20%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Constipation | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 1/5 (20%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Dyspepsia | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Nausea | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| General disorders | ||||||||||||||||||
| Fatigue | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 2/28 (7.1%) | 0/24 (0%) | 1/23 (4.3%) | 0/28 (0%) | 1/26 (3.8%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Balanitis candida | 1/5 (20%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 1/26 (3.8%) | |||||||||
| Urinary tract infection | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 2/23 (8.7%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Contusion | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Scratch | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||
| Hypomagnesaemia | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| Dizziness | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Headache | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 0/5 (0%) | 1/28 (3.6%) | 3/24 (12.5%) | 1/23 (4.3%) | 4/28 (14.3%) | 3/26 (11.5%) | |||||||||
| Renal and urinary disorders | ||||||||||||||||||
| Pollakiuria | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 2/23 (8.7%) | 1/28 (3.6%) | 1/26 (3.8%) | |||||||||
| Polyuria | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 1/28 (3.6%) | 0/24 (0%) | 0/23 (0%) | 2/28 (7.1%) | 0/26 (0%) | |||||||||
| Reproductive system and breast disorders | ||||||||||||||||||
| Vulvovaginal pain | 1/5 (20%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Vulvovaginal pruritus | 1/5 (20%) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Cough | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Nasal discomfort | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) | 0/5 (0%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 0/26 (0%) | |||||||||
| Oropharyngeal pain | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) | 0/28 (0%) | 0/24 (0%) | 0/23 (0%) | 0/28 (0%) | 2/26 (7.7%) | |||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Investigator does not have the right to publish trial results.
Results Point of Contact
| Name/Title | Albert Collinson |
|---|---|
| Organization | Theracos, Inc. |
| Phone | (508) 630-2129 |
| acollinson@theracos.com |
Responsible Party:
Theracos
ClinicalTrials.gov Identifier:
NCT01029704
Other Study ID Numbers:
- THR-1442-C-402
First Posted:
Dec 10, 2009
Last Update Posted:
Jun 16, 2021
Last Verified:
Jun 1, 2021