Diabetes Mellitus, Type 2LUCIDNCT05103306
Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy
An observational study of Diabetes Mellitus, Type 2, run by Chungbuk National University Hospital.
Trial summary
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy 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
- What is being tested?
- Empagliflozin 25 MG and INS
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2022
- How long will I take part?
- 3 Years
- 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: Type 2 diabetes, uncontrolled with triple OADs
Who may be able to join
- Inadequately controlled with triple OADs (metformin, glimepiride, dipeptidyl peptidase-4 inhibitor) showing HbA1c 7.5-12.0%
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: Long-term Effectiveness and Safety of Empagliflozin-based Quadruple Oral Antidiabetic Agents Therapy Compared to Basal Insulin-based Combination Therapy in Patients With Type 2 Diabetes
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
Read the detailed description
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Empagliflozin 25 MG, INS
- Keywords
- Type 2 diabetes mellitus, Sodium-glucose co-transporter 2 inhibitor, Empagliflozin, Insulin glargine, Insulin degludec
- 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.
Empagliflozin 25 MGDrug
Empagliflozin 25mg/day add-on to triple combination oral antidiabetic agents consisted with metformin, glimepiride, and DPP4 inhibitor
INSDrug
Also called Basal insulin
Basal insulin add on the background OADs
| Study group | Role | What they receive |
|---|---|---|
| Triple OADs failure | Inadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor Receives: Drug: Empagliflozin 25 MG; Drug: INS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c From Baseline to months 36
Changes in HbA1c From Baseline to months 36 (3-year)
Measured: Baseline, month 36 (3-year)
Secondary outcomes (8)
Achievement of target HbA1c
Percentage of Patients Who Achieved Glycemic Target of HbA1c at month 36
Measured: Baseline, month 36
Changes in HbA1c
Changes in HbA1c From Baseline to each time frame
Measured: Baseline, month 3, 6, 12, 18, 24, 30
Changes in FPG
Changes in fasting plasma glucose level from baseline to each month
Measured: Baseline, month 3, 6, 12, 18, 24, 30, 36
Changes in lipid profiles
Changes in total cholesterol, triglyceride, HDL-cholesterol and LDL cholesterol from baseline to month 36
Measured: Baseline, month 36
Changes in body weight
Changes in body weight from baseline to month 36
Measured: Baseline, month 36
Changes in blood pressure
Changes in systolic and diastolic blood pressure from baseline to month 36
Measured: Baseline, month 36
Percentage of patients with hypoglycemic episodes
All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected.
Measured: Baseline, month 36
Percentage of patients with at least 1 episode of genitourinary tract infections
Percentage of Patients With At Least 1 Episode of Genitourinary Tract Infections
Measured: Baseline, month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study startJan 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chungbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eu Jeong Ku, Chungbuk National University Hospital
- Investigators
- Eu Jeong Ku, MD, PhD, Principal investigator, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103306
- Sponsor's protocol ID
- CBNUH-LUCID
- Acronym
- LUCID
- Status last verified
- Jul 2022
- First submitted
- 1 Nov 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ku EJ, Oh TK. Long-Term Effectiveness of Quadruple Combination Therapy with Empagliflozin Versus Basal Long-Acting Insulin Therapy in Patients with Type 2 Diabetes: 3-Year Retrospective Observational Study. Diabetes Ther. 2023 Sep;14(9):1471-1479. doi: 10.1007/s13300-023-01437-x. Epub 2023 Jun 27.
PubMed 37369826
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effectiveness and Safety of Empagliflozin-based Quadruple Oral Antidiabetic Agents Therapy Compared to Basal Insulin-based Combination Therapy in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05103306
- Acronym / sponsor ID
- LUCID / CBNUH-LUCID
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus, Sodium-glucose co-transporter 2 inhibitor, Empagliflozin, Insulin glargine, Insulin degludec
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chungbuk National University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
Detailed description
This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple OADs failure | – | Drug: Empagliflozin 25 MG, Drug: INSInadequatelly controlled type 2 diabetes patients despite triple combination therapy with metformin, glimepiride, and DPP-4 inhibitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes, uncontrolled with triple OADs
Key inclusion criteria (1 listed)
- Inadequately controlled with triple OADs (metformin, glimepiride, dipeptidyl peptidase-4 inhibitor) showing HbA1c 7.5-12.0%
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Gestional diabetes
- Diabetes due to secondary causes
- Receiving anticancer treatment
- Receiving glucocorticoids or immune-suppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 25 MGEmpagliflozin 25mg/day add-on to triple combination oral antidiabetic agents consisted with metformin, glimepiride, and DPP4 inhibitor | Drug | Triple OADs failure |
| INSAlso: Basal insulinBasal insulin add on the background OADs | Drug | Triple OADs failure |
Primary outcome
Changes in HbA1c From Baseline to months 36
Time frame: Baseline, month 36 (3-year)
Changes in HbA1c From Baseline to months 36 (3-year)
8 secondary outcomes
Achievement of target HbA1c
Time frame: Baseline, month 36
Changes in HbA1c
Time frame: Baseline, month 3, 6, 12, 18, 24, 30
Changes in FPG
Time frame: Baseline, month 3, 6, 12, 18, 24, 30, 36
Changes in lipid profiles
Time frame: Baseline, month 36
Changes in body weight
Time frame: Baseline, month 36
Changes in blood pressure
Time frame: Baseline, month 36
Percentage of patients with hypoglycemic episodes
Time frame: Baseline, month 36
Percentage of patients with at least 1 episode of genitourinary tract infections
Time frame: Baseline, month 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 37369826Ku EJ, Oh TK. Long-Term Effectiveness of Quadruple Combination Therapy with Empagliflozin Versus Basal Long-Acting Insulin Therapy in Patients with Type 2 Diabetes: 3-Year Retrospective Observational Study. Diabetes Ther. 2023 Sep;14(9):1471-1479. doi: 10.1007/s13300-023-01437-x. Epub 2023 Jun 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eu Jeong Ku, MD, PhD principal investigator
Chungbuk National University Hospital
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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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?
Results are not available in the source record.
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 months 36 (time frame: Baseline, month 36 (3-year)). 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 NCT05103306, which also lists 1 linked publication.
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 20 Jul 2022.