NCT04653779

Brief Summary

Multi-center, open-label, single arm study to Evaluate the preference regarding convenience of medication, efficacy and safety of Sugamet XR tab. 5/1000mg in patients with Type 2 diabetes and renal diseases

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

November 19, 2020

Last Update Submit

December 10, 2020

Conditions

Diabetes Mellitus, Type 2Renal DiseaseDiabetes MellitusMetabolic DiseaseEndocrine System Diseases

Outcome Measures

Primary Outcomes (1)

  • The preference regarding convenience of medication

    Looking back on the experience of participating in the study, which would you prefer, any of the existing DPP-4 inhibitor/metformin 1000mg sustained-release combination drug or the SugarMet® sustained-release tablet 5/1000mg?

    12 weeks

Secondary Outcomes (9)

  • Change from baseline in HbA1c (%) After 12 weeks

    12 weeks

  • Change from baseline in HbA1C response rate(%) After 12 weeks

    12 weeks

  • Change from baseline in Glycated albumin After 12 weeks

    12 weeks

  • Change from baseline in e-GFR After 12 weeks

    12 weeks

  • Change from baseline in UACR After 12 weeks

    12 weeks

  • +4 more secondary outcomes

Study Arms (1)

Group A

EXPERIMENTAL

Patients receive Evogliptin 5mg/Metformin 1000mg once a day

Drug: Evogliptin 5mg/Metformin 1000mg

Interventions

Evogliptin 5mg/Metformin 1000mgDRUG

Size reduction of a tablet formulation

Also known as: SUGAMET®XR tablet 5/1000mg
Group A

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥60 years
  • Subjects with type 2 diabetes mellitus
  • Subjects treated with DPP-4 inhibitor and 1,000mg/day dose of metformin 1T/qd for at least 8 weeks prior to screening
  • Subjects with HbA1c≤7.5% at screening
  • Subjects with 45mL/min/1.73m2≤eGFR≤90mL/min/1.73m2 at screening
  • Subjects with fasting glucose≤200 at screening
  • Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening

You may not qualify if:

  • Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
  • ESRD or Patients who have kidney dialysis
  • Subjects with ALT and AST 3 times or higher than upper normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Suncheonhyang Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

Se-jong hospital

Bucheon-si, Gyeonggi-do, 14754, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Kidney DiseasesDiabetes MellitusMetabolic DiseasesEndocrine System Diseases

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-oneMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersNutritional and Metabolic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

Sung

CONTACT

82-2-920-8369jhsung@donga.co.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 4, 2020

Study Start

December 1, 2020

Primary Completion

May 1, 2021

Study Completion

July 1, 2021

Last Updated

December 11, 2020

Record last verified: 2020-12

Locations

KR(2)