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Diabetes Mellitus, Type 2NCT03473262

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

An observational study of Diabetes Mellitus, Type 2, run by Chungbuk National University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
How many people
200 participants
Where
No sites listed yet
Study dates
1 Jan 2017to 18 Jul 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

About this study

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

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.

Keywords
Type 2 diabetes, Sodium glucose cotransporter 2 inhibitor, Empagliflozin, Insulin glargine
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03473262
Study groupRoleWhat they receive
EMPAEmpagliflozin 25 mg/day
INSInsulin Glargine dose-titrated

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in HbA1c From Baseline to Week 24

    Measured: Baseline, Week 24

  2. Changes in Fasting Plasma Glucose From Baseline to Week 24

    Measured: Baseline, Week 24

Secondary outcomes (13)

  1. Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤7.0% at Week 24

    Measured: Baseline, Week 24

  2. Changes in HbA1c From Baseline to Week 12

    Measured: Baseline, Week 12

  3. Changes in Fasting Plasma Glucose From Baseline to Week 12

    Measured: Baseline, Week 24

  4. Changes in Weight Between Baseline and Week 24

    Measured: Baseline, Week 24

  5. Changes in Body Mass Index Between Baseline and Week 24

    Measured: Baseline, Week 24

  6. Changes in Total Cholesterol Between Baseline and Week 24

    Measured: Baseline, Week 24

  7. Changes in HDL Cholesterol Between Baseline and Week 24

    Measured: Baseline, Week 24

  8. Changes in LDL Cholesterol Between Baseline and Week 24

    Measured: Baseline, Week 24

  9. Changes in Triglycerides Between Baseline and Week 24

    Measured: Baseline, Week 24

  10. Changes in Systolic Blood Pressure Between Baseline and Week 24

    Measured: Baseline, Week 24

  11. Changes in Dystolic Blood Pressure Between Baseline and Week 24

    Measured: Baseline, Week 24

  12. 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.

    Measured: Baseline, Week 24

  13. Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections Between Baseline and Week 24

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2018
  2. Study start1 Jan 2017
  3. Primary completion18 Jul 2018
  4. Study completion18 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03473262
Sponsor's protocol ID
2017-03-011
Other IDs
eujeongku
Status last verified
Mar 2018
First submitted
15 Mar 2018
Last updated
19 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Chungbuk National University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in HbA1c From Baseline to Week 24 (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473262.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.

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