Ignite Creation Date:
2024-05-06 @ 8:11 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02689362
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2016-02-10
Brief Title:
Evogliptin in Type 2 Diabetes Mellitus EVOLUTION EVOgLiptina no Diabetes Mellitus TIpO 2
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Double-Dummy Active Controlled Clinical Trial for the Validation of Optimum Dose and Preliminary Evaluation of Efficacy and Safety of Evogliptin in Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2018-08
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:
EVOLUTION
Brief Summary:
This phase II multicenter randomized double-blind double-dummy study with four parallel treatment groups with active control will be performed only in brazilian sites under the sponsorship of Eurofarma Laboratórios SA The enrollment for participants in the study will start after the relevant ethical and regulatory approvals and will have an estimated duration of 18 months
One hundred and forty-four participants with T2DM according to the criteria of ADA who consent to participation in the study by signing the Informed Consent Form ICF will be enrolled in the study In order to be enrolled the patients must meet all the inclusion criteria and none of the exclusion criteria The eligible participants will be randomized 1111 to receive evogliptin EVO at the doses of 25 mgday N 36 50 mgday N 36 or 10 mgday N 36 or sitagliptin SITA at the dose of 100 mgday N 36 as a single daily dose for 12 weeks
One hundred and forty-four participants with T2DM according to the criteria of ADA who consent to participation in the study by signing the Informed Consent Form ICF will be enrolled in the study In order to be enrolled the patients must meet all the inclusion criteria and none of the exclusion criteria The eligible participants will be randomized 1111 to receive evogliptin EVO at the doses of 25 mgday N 36 50 mgday N 36 or 10 mgday N 36 or sitagliptin SITA at the dose of 100 mgday N 36 as a single daily dose for 12 weeks
Detailed Description:
None
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