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Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

evogliptin

Sitagliptin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with 6.5%≤HbA1c≤11.0% at screening
Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening
Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

Subjects with fasting plasma glucose≥270mg/dL at screening
Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
Subjects with ALT and AST 2.5 times or higher than upper normal range

Sites / Locations

Kangbuk Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

evogliptin

sitagliptin

Arm Description

evogliptin 5mg qd add-on to metformin

sitagliptin 100mg qd add-on to metformin

Outcomes

Primary Outcome Measures

HbA1c

unit: %

Secondary Outcome Measures

fasting plasma glucose

unit : mg/dL

HOMA-beta

unit: %

HbA1c response rate

unit: %

Full Information

NCT ID

NCT02949193

First Posted

February 23, 2014

Last Updated

October 27, 2016

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02949193

Brief Title

Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

Official Title

A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Detailed Description

Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks. Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

222 (Actual)

8. Arms, Groups, and Interventions

Arm Title

evogliptin

Arm Type

Experimental

Arm Description

evogliptin 5mg qd add-on to metformin

Arm Title

sitagliptin

Arm Type

Active Comparator

Arm Description

sitagliptin 100mg qd add-on to metformin

Intervention Type

Drug

Intervention Name(s)

evogliptin

Other Intervention Name(s)

Suganon

Intervention Description

evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Other Intervention Name(s)

januvia

Intervention Description

sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg

Primary Outcome Measure Information:

Title

HbA1c

Description

unit: %

Time Frame

Change from baseline at 24 week

Secondary Outcome Measure Information:

Title

fasting plasma glucose

Description

unit : mg/dL

Time Frame

Change from baseline at 24 week

Title

HOMA-beta

Description

unit: %

Time Frame

Change from baseline at 24 week

Title

HbA1c response rate

Description

unit: %

Time Frame

Change from baseline at 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with 6.5%≤HbA1c≤11.0% at screening Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening Subjects with 20kg/m2≤BMI≤40kg/m2 at screening Exclusion Criteria: Subjects with fasting plasma glucose≥270mg/dL at screening Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening Subjects with ALT and AST 2.5 times or higher than upper normal range

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sung Woo Park, M.D., Ph.D.

Organizational Affiliation

Kangbuk Samsung Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kangbuk Samsung Medical Center

City

Seoul

ZIP/Postal Code

110-746

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

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