Type2 DiabetesPhase 4NCT03458715
The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin
A Phase 4 study testing SGLT2 inhibitor (Empagliflozin 25 MG) and DPP4 inhibitor (Linagliptin 5 MG) in people with Type2 Diabetes, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The population of type 2 diabetes increased enormously worldwide. As disease progression, uncontrolled type 2 diabetes patients need multiple daily insulin injections, but the risk of body weight gain and hypoglycemia will increase. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- SGLT2 inhibitor (Empagliflozin 25 MG) and DPP4 inhibitor (Linagliptin 5 MG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Sep 2017to 21 Nov 2018
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patient received premix insulin twice daily and HbA1c>7%
- >20 years old
Who cannot join
- Type 1 diabetes and gestational diabetes
- Diabetic ketoacidosis in previous 6 months
- Urinary tract infection in previous 6 months
- Pancreatitis in previous 6 months
- estimated GFR<45 mL/min/1.73m2
- Patient whom already received DPP4 inhibitor or SGLT2 inhibitor
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
Taipei, 10449
Yi-Hong Zeng, MD, +886-2-25433535 ext. 2174, starrydouchain@yahoo.com.tw
Sung-Chen Liu, MD
About this study
Official title: The Efficacy and Safety of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase 4 Inhibitor Added to Premix Insulin Injection Twice Daily in Uncontrolled Type 2 Diabetes Patients
The population of type 2 diabetes increased enormously worldwide. As disease progression, uncontrolled type 2 diabetes patients need multiple daily insulin injections, but the risk of body weight gain and hypoglycemia will increase. In recent years, the newly oral anti-hypoglycemic agents developed, such as dipeptidyl peptidase-4 inhibitors (DPP4i) and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The former indirectly stimulate insulin secretion and suppress glucagon through increase incretin. The later inhibit re-absorption of blood glucose in proximal renal tubule to improve hyperglycemia. According to the guideline published in 2017 by American diabetes Associations, if patients received premix insulin injections twice daily and their glycemic control can't meet the target, increase the frequency of injection such as basal bolus would be considered. However, it is difficult for some patients and it may cause more hypoglycemia and gain of body weight. Because previous report revealed dipeptidyl peptidase-4 inhibitors or sodium-glucose co-transporter 2 inhibitors added to insulin resulted in better glycemic control, but there was no direct comparison, so we design this study to observe the efficacy of these two drugs in uncontrolled diabetes patient received twice daily insulin injections.
- Conditions
- Type2 Diabetes
- Being tested
- SGLT2 inhibitor (Empagliflozin 25 MG), DPP4 inhibitor (Linagliptin 5 MG)
- Keywords
- SGLT2 inhibitor, DPP4 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitor (Empagliflozin 25 MG)Drug
Also called Jardiance
We randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy.
DPP4 inhibitor (Linagliptin 5 MG)Drug
Also called Trajenta
We randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy.
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 inhibitor (Empagliflozin 25 MG) | Experimental | We add SGLT2 inhibitor (Empagliflozin 25 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy for 6 months. Receives: Drug: SGLT2 inhibitor (Empagliflozin 25 MG) |
| DPP4 inhibitor (Linagliptin 5 MG) | Active comparator | We add DPP4 inhibitor (Linagliptin 5 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy.for 6 months. Receives: Drug: DPP4 inhibitor (Linagliptin 5 MG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c)
change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24
Measured: measurement at baseline, 12 week and 24 week
Secondary outcomes (4)
Fasting blood glucose
change in fasting blood glucose in mg/dl from baseline to week 24
Measured: measurement at baseline, 12 week and 24 week
Postprandial blood glucose
change in postprandial blood glucose in mg/dl from baseline to week 24
Measured: measurement at baseline, 12 week and 24 week
Body weight
change in body weight in kilogram from baseline to week 24
Measured: measurement at baseline, 12 week and 24 week
Hypoglycemia event
documented hypoglycemia (glucose monitor <70mg/dl with hypoglycemia associated symptoms) from baseline to week 24
Measured: recorded at 12 week and 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start21 Sep 2017
- Primary completion21 Sep 2018 (estimated)
- Study completion21 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458715
- Sponsor's protocol ID
- 17MMHIS083
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2017
- Last updated
- 8 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zeng YH, Liu SC, Lee CC, Sun FJ, Liu JJ. Effect of empagliflozin versus linagliptin on body composition in Asian patients with type 2 diabetes treated with premixed insulin. Sci Rep. 2022 Oct 12;12(1):17065. doi: 10.1038/s41598-022-21486-9.
PubMed 36224294Liu SC, Lee CC, Chuang SM, Sun FJ, Zeng YH. Comparison of efficacy and safety of empagliflozin vs linagliptin added to premixed insulin in patients with uncontrolled type 2 diabetes: A randomized, open-label study. Diabetes Metab. 2021 May;47(3):101184. doi: 10.1016/j.diabet.2020.08.001. Epub 2020 Aug 19.
PubMed 32827752
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase 4 Inhibitor Added to Premix Insulin Injection Twice Daily in Uncontrolled Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT03458715
- Acronym / sponsor ID
- 17MMHIS083
- Conditions
- Type2 Diabetes
- Keywords
- SGLT2 inhibitor, DPP4 inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 21 Sep 2018 (estimated)
- Study completion
- 21 Nov 2018 (estimated)
- First posted
- 8 Mar 2018 (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.
The population of type 2 diabetes increased enormously worldwide. As disease progression, uncontrolled type 2 diabetes patients need multiple daily insulin injections, but the risk of body weight gain and hypoglycemia will increase. In recent years, the newly oral anti-hypoglycemic agents developed, such as dipeptidyl peptidase-4 inhibitors (DPP4i) and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The former indirectly stimulate insulin secretion and suppress glucagon through increase incretin. The later inhibit re-absorption of blood glucose in proximal renal tubule to improve hyperglycemia. According to the guideline published in 2017 by American diabetes Associations, if patients received premix insulin injections twice daily and their glycemic control can't meet the target, increase the frequency of injection such as basal bolus would be considered. However, it is difficult for some patients and it may cause more hypoglycemia and gain of body weight. Because previous report revealed dipeptidyl peptidase-4 inhibitors or sodium-glucose co-transporter 2 inhibitors added to insulin resulted in better glycemic control, but there was no direct comparison, so we design this study to observe the efficacy of these two drugs in uncontrolled diabetes patient received twice daily insulin injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2 inhibitor (Empagliflozin 25 MG) | Experimental | Drug: SGLT2 inhibitor (Empagliflozin 25 MG)We add SGLT2 inhibitor (Empagliflozin 25 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy for 6 months. |
| DPP4 inhibitor (Linagliptin 5 MG) | Active comparator | Drug: DPP4 inhibitor (Linagliptin 5 MG)We add DPP4 inhibitor (Linagliptin 5 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy.for 6 months. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes patient received premix insulin twice daily and HbA1c>7%
- >20 years old
Key exclusion criteria (6 listed)
- Type 1 diabetes and gestational diabetes
- Diabetic ketoacidosis in previous 6 months
- Urinary tract infection in previous 6 months
- Pancreatitis in previous 6 months
- estimated GFR<45 mL/min/1.73m2
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 |
|---|---|---|
| SGLT2 inhibitor (Empagliflozin 25 MG)Also: JardianceWe randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy. | Drug | SGLT2 inhibitor (Empagliflozin 25 MG) |
| DPP4 inhibitor (Linagliptin 5 MG)Also: TrajentaWe randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy. | Drug | DPP4 inhibitor (Linagliptin 5 MG) |
Primary outcome
Glycated hemoglobin (HbA1c)
Time frame: measurement at baseline, 12 week and 24 week
change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24
4 secondary outcomes
Fasting blood glucose
Time frame: measurement at baseline, 12 week and 24 week
Postprandial blood glucose
Time frame: measurement at baseline, 12 week and 24 week
Body weight
Time frame: measurement at baseline, 12 week and 24 week
Hypoglycemia event
Time frame: recorded at 12 week and 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Derived from this study: PubMed 36224294Zeng YH, Liu SC, Lee CC, Sun FJ, Liu JJ. Effect of empagliflozin versus linagliptin on body composition in Asian patients with type 2 diabetes treated with premixed insulin. Sci Rep. 2022 Oct 12;12(1):17065. doi: 10.1038/s41598-022-21486-9.
- Derived from this study: PubMed 32827752Liu SC, Lee CC, Chuang SM, Sun FJ, Zeng YH. Comparison of efficacy and safety of empagliflozin vs linagliptin added to premixed insulin in patients with uncontrolled type 2 diabetes: A randomized, open-label study. Diabetes Metab. 2021 May;47(3):101184. doi: 10.1016/j.diabet.2020.08.001. Epub 2020 Aug 19.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SGLT2 inhibitor (Empagliflozin 25 MG) and DPP4 inhibitor (Linagliptin 5 MG) in people with Type2 Diabetes, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yi-Hong Zeng, MD (+886-975835827, starrydouchain@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (HbA1c) (time frame: measurement at baseline, 12 week and 24 week). 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 NCT03458715, which also lists 2 linked publications.
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 8 Mar 2018.