| Trial ID: | L2808 |
| Source ID: | NCT01029704
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| Associated Drug: |
Egt0001442
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| Title: |
Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01029704/results
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| Conditions: |
Diabetes Mellitus Type 2
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| Interventions: |
DRUG: EGT0001442|DRUG: Placebo capsules to match EGT0001442
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| Outcome Measures: |
Primary: Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study, 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., Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29|Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4, 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., Pre-dose to 48 h post-dose|Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4, 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., Pre-dose to 48 h post-dose | Secondary: Change in the Body Weight From Baseline at Week 4, 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., Baseline and Day 29|Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4, 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), Baseline and Day 29|Change in Urinary Glucose Excretion From Baseline to 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)., Baseline, Day 1 and Day 28|Change in FPG Following Cessation of Treatment, 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)., Days 27/29 to Days 41/43
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| Sponsor/Collaborators: |
Sponsor: Theracos
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
151
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2009-12
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| Completion Date: |
2010-07
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| Results First Posted: |
2011-07-20
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| Last Update Posted: |
2021-06-16
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| Locations: |
Research Site #10, Birmingham, Alabama, United States|Research Site #04, National City, California, United States|Research Site #12, Denver, Colorado, United States|Research Site #07, Miami, Florida, United States|Research Site #08, Miami, Florida, United States|Research Site #06, Reading, Pennsylvania, United States|Research Site #11, DeSoto, Texas, United States|Research Site #01, San Antonio, Texas, United States|Research Site #15, San Antonio, Texas, United States|Research Site #03, Brampton, Ontario, Canada|Research Site #13, London, Ontario, Canada|Research Site #02, Mississauga, Ontario, Canada
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| URL: |
https://clinicaltrials.gov/show/NCT01029704
|
