Clinical trial NCT03473262: Empagliflozin-based Quadruple Combination vs Insulin Glarine-based Combination Therapy in Patients With Type 2 Diabetes
Official title: Efficacy and Safety of Empagliflozin vs. Insulin Glargine add-on Therapy in Patients With Inadequately Controlled Type 2 Diabetes Under Triple Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Sodium glucose cotransporter 2 inhibitor
Empagliflozin
Insulin glargine
Lead sponsor: Chungbuk National University Hospital
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in HbA1c From Baseline to Week 24
timeFrame: Baseline, Week 24
measure: Changes in Fasting Plasma Glucose From Baseline to Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24
timeFrame: Baseline, Week 24
measure: Changes in HbA1c From Baseline to Week 12
timeFrame: Baseline, Week 12
measure: Changes in Fasting Plasma Glucose From Baseline to Week 12
timeFrame: Baseline, Week 24
measure: Changes in Weight Between Baseline and Week 24
timeFrame: Baseline, Week 24
measure: Changes in Body Mass Index Between Baseline and Week 24
timeFrame: Baseline, Week 24
measure: Changes in Total Cholesterol Between Baseline and Week 24
timeFrame: Baseline, Week 24
measure: Changes in HDL Cholesterol Between Baseline and Week 24
timeFrame: Baseline, Week 24
measure: Changes in LDL Cholesterol Between Baseline and Week 24
timeFrame: Baseline, Week 24
measure: Changes in Triglycerides Between Baseline and Week 24
timeFrame: Baseline, Week 24
measure: Changes in Systolic Blood Pressure Between Baseline and Week 24
timeFrame: Baseline, Week 24
measure: Changes in Dystolic Blood Pressure Between Baseline and Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Patients With Hypoglycemia Episodes Between Baseline and Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections Between Baseline and Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
Study officials:
References: