Empagliflozin-based Quadruple Combination vs Insulin Glarine-based Combination Therapy in Patients With Type 2 Diabetes

Efficacy and Safety of Empagliflozin vs. Insulin Glargine add-on Therapy in Patients With Inadequately Controlled Type 2 Diabetes Under Triple Combination Therapy

This study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared to insulin glargine-based antidiabetic agents (OADs) combination thearpy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2

• Study Type: Observational
• Enrollment (Actual): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The targeted population consists of adult patients with type 2 diabetes mellitus treated in outpatient setting by specialists.

Description

Inclusion Criteria:

• Are inadequately controlled with triple OADs (metformin, sulfonylurea, dipeptidyl peptidase inhibitor) as evidenced by HbA1c >7.5% and <12.0%

Exclusion Criteria:

• Type 1 diabetes
• Gestional diabetes
• Diabetes due to secondary causes
• Receiving anticancer treatment
• Receiving glucocorticoids or immune-suppressants
• Have been treated with sodium glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering the study
• Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
EMPA; Empagliflozin 25 mg/day
INS; Insulin Glargine dose-titrated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in HbA1c From Baseline to Week 24	Baseline, Week 24
Changes in Fasting Plasma Glucose From Baseline to Week 24	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24		Baseline, Week 24
Changes in HbA1c From Baseline to Week 12		Baseline, Week 12
Changes in Fasting Plasma Glucose From Baseline to Week 12		Baseline, Week 24
Changes in Weight Between Baseline and Week 24		Baseline, Week 24
Changes in Body Mass Index Between Baseline and Week 24		Baseline, Week 24
Changes in Total Cholesterol Between Baseline and Week 24		Baseline, Week 24
Changes in HDL Cholesterol Between Baseline and Week 24		Baseline, Week 24
Changes in LDL Cholesterol Between Baseline and Week 24		Baseline, Week 24
Changes in Triglycerides Between Baseline and Week 24		Baseline, Week 24
Changes in Systolic Blood Pressure Between Baseline and Week 24		Baseline, Week 24
Changes in Dystolic Blood Pressure Between Baseline and Week 24		Baseline, Week 24
Percentage of Patients With Hypoglycemia Episodes Between Baseline and Week 24	All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.	Baseline, Week 24
Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections Between Baseline and Week 24		Baseline, Week 24

Collaborators and Investigators

• Sponsor: Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): July 18, 2018

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Empagliflozin; Insulin glargine; Sodium glucose cotransporter 2 inhibitor
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2017-03-011; eujeongku (Registry Identifier: Eu Jeong Ku)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No