Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04706637
Status:
UNKNOWN
Last Update Posted:
2021-01-13
First Post:
2020-12-29
Brief Title:
A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin
Sponsor:
Kyung Hee University Hospital at Gangdong
Organization:
Kyung Hee University Hospital at Gangdong
Study Overview
Official Title:
A Multicenter Randomized Exploratory Clinical Trial to Evaluate the Effect of Bone Metabolism and the Efficacy of Evogliptin and Dapagliflozin for Blood Sugar in the Menopause Female Patients With Osteopenia and Type 2 Diabetes
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
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:
EVOMETA
Brief Summary:
This multi-center randomized and exploratory clinical trial is designed to evaluate the effect of bone metabolism and blood sugar of evogliptin and dapagliflozin in the menopause female patients with osteopenia and type 2 diabetes
The trial will evaluate bone metabolism bone markers and bone density and blood sugar AGE and glucose variability after 12 weeks and 48 weeks
This clinical trial conducts in two arms and each arm recruits 60 subjects
The trial will evaluate bone metabolism bone markers and bone density and blood sugar AGE and glucose variability after 12 weeks and 48 weeks
This clinical trial conducts in two arms and each arm recruits 60 subjects
Detailed Description:
This clinical trial is to evaluate the effect of bone metabolism and blood sugar of evogliptin and dapagliflozin in the menopause female patients with osteopenia and type 2 diabetes
Bone metabolism bone markers and bone density and blood sugar AGE and glucose variability after 12 weeks and 48 weeks will be evaluated
This clinical trial conducts in two arms and each arm recruits 60 subjects If a subject voluntarily agrees to participate and meets the inclusion and exclusion criteria for the clinical trial the subject will be randomly assigned to one of the two arms
The total period after the subject enrollment is 48 weeks and a total of six visits are made with screening baseline 12 weeks 24 weeks 36 weeks and 48 weeks
Efficacy evaluation will be carried out changes on blood sugar bone markers and density and after 12 and 48 weeks
The results of this study are intended to be a reference to future clinical trials
Bone metabolism bone markers and bone density and blood sugar AGE and glucose variability after 12 weeks and 48 weeks will be evaluated
This clinical trial conducts in two arms and each arm recruits 60 subjects If a subject voluntarily agrees to participate and meets the inclusion and exclusion criteria for the clinical trial the subject will be randomly assigned to one of the two arms
The total period after the subject enrollment is 48 weeks and a total of six visits are made with screening baseline 12 weeks 24 weeks 36 weeks and 48 weeks
Efficacy evaluation will be carried out changes on blood sugar bone markers and density and after 12 and 48 weeks
The results of this study are intended to be a reference to future clinical trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None