Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01377844
Status:
COMPLETED
Last Update Posted:
2021-07-01
First Post:
2011-06-13
Brief Title:
Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus
Sponsor:
Theracos
Organization:
Theracos
Study Overview
Official Title:
Efficacy and Safety of EGT0001442 Compared With Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled by Diet and Exercise and up to One Oral Anti-diabetes Agent
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin HbA1c A laboratory test to diagnose three months average of blood sugarlevels at 24th week from baseline when compared to placebo groupno diabetic medication given The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the results with placebo group This study assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association ADA target of HbA1c of 7 in EGT0001442 group and comparison with placebo The study also evaluates the effect of EGT0001442 on systolic diastolic pressures body weight and compare with the respective placebo groupsThis study also assess the change from baseline in HbA1c overtime from week 1 to week 96 Finally to assess the safety of EGT0001442 in the Type 2 Diabetic patients adultmaturity onset
Detailed Description:
EGT0001442 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters The use of EGT0001442 may enhance the elimination of glucose from the blood by increasing the amount of urine produced Hence the blood glucose levels are significantly decreased and the efficacy of EGT001442 can be established by assessing the three months average blood glucose levels HbA1c Due to the increased urinary output the effect of EGT001442 on blood pressure levels are also assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None