NCT02964572

Brief Summary

  • Single-center, prospective, active-controlled, open, randomized, 2 arm parallel, interventional, exploratory pilot
  • Type 2 diabetic patients with high cardiovascular risks who have inadequate glycaemic control with metformin-based oral hypoglycemic agents will be prescribed glimepiride (comparison group) or empagliflozin (study group) for 60 days (plus or minus 32 days) as add-on therapy
  • Changes in IL-1beta secretion, serum beta-hydroxybutyrate concentration, and NLRP3 inflammasome activity from baseline to final timepoint will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

8 months

First QC Date

November 11, 2016

Last Update Submit

August 24, 2020

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • changes in the secretion of IL-1 beta from peripheral blood mononuclear cells

    The effect of empagliflozin on the secretion of IL-1beta from peripheral blood mononuclear cells

    Day 60

Secondary Outcomes (15)

  • Changes in the secretion of TNF-alpha from peripheral blood mononuclear cells, before and after the administration of empagliflozin or glimepiride

    Day 60 plus or minus 32 days

  • Changes in serum concentrations of beta-hydroxybutyrate, before and after the administration of empagliflozin or glimepiride

    Day 60 plus or minus 32 days

  • Changes in body weight (kg), before and after the administration of empagliflozin or glimepiride

    Day 60 plus or minus 32 days

  • Changes in serum concentrations of insulin (µU/mL), before and after the administration of empagliflozin or glimepiride

    Day 60 plus or minus 32 days

  • Changes in serum concentrations of glucagon (pg/mL), before and after the administration of empagliflozin or glimepiride

    Day 60 plus or minus 32 days

  • +10 more secondary outcomes

Study Arms (2)

Glimepiride

ACTIVE COMPARATOR

Glimepiride (anti-diabetic drug) as a comparison group

Drug: Glimepiride

Empagliflozin

EXPERIMENTAL

Empagliflozin (anti-diabetic drug) as a study group

Drug: Empagliflozin

Interventions

GlimepirideDRUG

In accordance with the standard treatment guidelines of diabetes, glimepiride as a drug of active comparator will be administered to improve blood sugar in patients with poorly controlled blood sugar.

Also known as: Amaryl
Glimepiride
EmpagliflozinDRUG

Empagliflozin as a drug of experimental will be administered to improve blood sugar in patients with poorly controlled blood sugar.

Also known as: Jardiance
Empagliflozin

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥19 years
  • inadequate glycaemic control : HbA1c ≥6.5% or fasting glucose \>120 mg/dl or random glucose \>180 mg/dl
  • High risk of cardiovascular events defined as the presence of ≥1 of the following:
  • History of myocardial infarction
  • Evidence of multi-vessel coronary artery disease
  • Evidence of single-vessel coronary artery disease with a positive non-invasive stress test for ischemia or history of hospitalization for unstable angina
  • History of stroke
  • Evidence of occlusive peripheral artery disease
  • Evidence of carotid atherosclerosis
  • Metabolic syndrome
  • Healthy volunteers

You may not qualify if:

  • Type 1 diabetes
  • Organ transplantation
  • Pregnant women
  • eGFR \<45
  • Cortisol or growth hormone deficiency, pituitary diseases
  • Gastric surgery
  • Hematologic disorders
  • Active cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes center

Seoul, 03722, South Korea

Location

Related Publications (1)

  • Kim ER, Kim SR, Cho W, Lee SG, Kim SH, Kim JH, Choi E, Kim JH, Yu JW, Lee BW, Kang ES, Cha BS, Lee MS, Cho JW, Jeon JY, Lee YH. Short Term Isocaloric Ketogenic Diet Modulates NLRP3 Inflammasome Via B-hydroxybutyrate and Fibroblast Growth Factor 21. Front Immunol. 2022 Apr 28;13:843520. doi: 10.3389/fimmu.2022.843520. eCollection 2022.

    PMID: 35572519DERIVED

MeSH Terms

Interventions

glimepirideempagliflozin

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 16, 2016

Study Start

November 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

KR(1)