Diabetes Mellitus, Type 2Phase 4NCT02589626

Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA

A Phase 4 study testing empagliflozin 10mg and empagliflozin 25 mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 16 sites in Japan.

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 is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: empagliflozin 10mg and empagliflozin 25 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 16 sitesJapan
Study dates: 29 Oct 2015to 2 Jun 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of type 2 diabetes mellitus
Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be >=7.0% and <=10.0% at screening
Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10 weeks prior to Visit 1 must be >=7.0% and <=9.0% at screening and >=7.0% and <=10.0% at placebo run-in
Male and female patients on diet and exercise regimen who are pre-treated with OAD alone for at least 10 weeks prior to Visit 1 must be >=7.0% and <=10.0% at both screening and placebo run-in
Age at informed consent must be >=20 years
BMI at screening must be <=40 kg/m2
Further inclusion criteria apply

Who cannot join

Uncontrolled hyperglycaemia with a glucose values >270 mg/dL (>15.0 mmol/L) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement
Patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks prior to informed consent.
Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period
Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period
Further exclusion criteria apply

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Japan16 sites

Kunisaki Makoto Clinic
Fukuoka, Fukuoka, 819-0168
Seino I.M. Clinic, Fukushima, I.M.
Fukushima, Koriyama, 963-8851
Nippon Kokan Fukuyama Hospital
Hiroshima, Fukuyama, 721-0927
Nakakinen Clinic
Ibaraki, Naka, 311-0113
Kubota Clinic
Kanagawa, Kawasaki, 214-0014
Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
Kanagawa, Yamato-shi, 242-0004
Yokohama Minoru Clinic
Kanagawa, Yokohama, 232-0064
Yokkaichi Diabetes Clinic
Mie, Yokkaichi, 510-0829
Shiraiwa Medical Clinic
Osaka, Kashiwara-shi, 582-0005
AMC Nishi-umeda Clinic
Osaka, Osaka-shi, 530-0001
OCROM Clinic
Osaka, Suita, 565-0853
Fukuwa Clinic
Tokyo, Chuo-ku, 103-0027
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, 103-0027
Minamino Heart Clinic
Tokyo, Hachioji, 192-0918
ToCROM Clinic
Tokyo, Shinjuku-ku, 160-0022
Shinjuku Research Park Clinic
Tokyo, Shinjuku-ku, 169-0073

Other trials in Japan

About this study

Official title: A 52-week Randomised, Double-blind, Parallel Group, Safety and Efficacy Study of Empagliflozin Once Daily as add-on Therapy to Glucagon-like Peptide-1 Receptor Agonist in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control

Conditions: Diabetes Mellitus, Type 2
Being tested: empagliflozin 10mg, empagliflozin 25 mg, Placebo
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 10mgDrug
empagliflozin 25 mgDrug
PlaceboDrug
For blinding purposes

Study groups in NCT02589626
Study group	Role	What they receive
empagliflozin 10 mg	Experimental	empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet Receives: Drug: empagliflozin 10mg; Drug: Placebo
empagliflozin 25 mg	Experimental	empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet Receives: Drug: empagliflozin 25 mg; Drug: Placebo

What is being measured

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

Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented
Measured: 52 weeks

Secondary outcomes (1)

Change From Baseline in HbA1c After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means.
Measured: baseline and 52 weeks

Timeline

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

29 Oct 20152 Jun 2017

First posted28 Oct 2015 (estimated)
Study start29 Oct 2015
Primary completion2 Jun 2017
Study completion2 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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: Double blind
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02589626
Sponsor's protocol ID: 1245.106
Status last verified: Jan 2019
First submitted: 27 Oct 2015
Last updated: 7 Jan 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Terauchi Y, Utsunomiya K, Yasui A, Seki T, Cheng G, Shiki K, Lee J. Safety and Efficacy of Empagliflozin as Add-On Therapy to GLP-1 Receptor Agonist (Liraglutide) in Japanese Patients with Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Parallel-Group Phase 4 Study. Diabetes Ther. 2019 Jun;10(3):951-963. doi: 10.1007/s13300-019-0604-8. Epub 2019 Mar 25.
PubMed 30912033

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 52-week Randomised, Double-blind, Parallel Group, Safety and Efficacy Study of Empagliflozin Once Daily as add-on Therapy to Glucagon-like Peptide-1 Receptor Agonist in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control
ClinicalTrials.gov ID: NCT02589626
Acronym / sponsor ID: 1245.106
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 29 Oct 2015 (actual)
Primary completion: 2 Jun 2017 (actual)
Study completion: 2 Jun 2017 (actual)
First posted: 28 Oct 2015 (estimated)
Results: Posted 7 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
empagliflozin 10 mg	Experimental	Drug: empagliflozin 10mg, Drug: Placeboempagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
empagliflozin 25 mg	Experimental	Drug: empagliflozin 25 mg, Drug: Placeboempagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of type 2 diabetes mellitus
Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be >=7.0% and <=10.0% at screening
Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10 weeks prior to Visit 1 must be >=7.0% and <=9.0% at screening and >=7.0% and <=10.0% at placebo run-in
Male and female patients on diet and exercise regimen who are pre-treated with OAD alone for at least 10 weeks prior to Visit 1 must be >=7.0% and <=10.0% at both screening and placebo run-in
Age at informed consent must be >=20 years

Key exclusion criteria (6 listed)

Uncontrolled hyperglycaemia with a glucose values >270 mg/dL (>15.0 mmol/L) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement
Patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks prior to informed consent.
Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period
Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period

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 10mg	Drug	empagliflozin 10 mg
empagliflozin 25 mg	Drug	empagliflozin 25 mg
PlaceboFor blinding purposes	Drug	empagliflozin 10 mg, empagliflozin 25 mg

Primary outcome

Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
Time frame: 52 weeks
Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented

1 secondary outcome

Change From Baseline in HbA1c After 52 Weeks of Treatment
Time frame: baseline and 52 weeks

Results and safety

Results posted to the registry on 7 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Empagliflozin 10 mg	32	29
Empagliflozin 25 mg	33	31

Primary outcome: Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment

Time frame: 52 weeks. Number. Unit: Percentage of participants

Measure	Empagliflozin 10 mg n = 32	Empagliflozin 25 mg n = 33
Value	9.4	21.2

Population analysed: The treated set (TS) consisted of all patients who were randomised and treated with at least 1 dose of the study drug. The assignment of patients to treatment group was based on the first study drug intake in the double-blind treatment period.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All AEs which occurred through the treatment phase and throughout the residual effect period (REP); up to 53 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Empagliflozin 10 mg	2 of 32 (6.3%)	10 of 32 (31.3%)	0 of 32
Empagliflozin 25mg	1 of 33 (3%)	15 of 33 (45.5%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30912033Terauchi Y, Utsunomiya K, Yasui A, Seki T, Cheng G, Shiki K, Lee J. Safety and Efficacy of Empagliflozin as Add-On Therapy to GLP-1 Receptor Agonist (Liraglutide) in Japanese Patients with Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Parallel-Group Phase 4 Study. Diabetes Ther. 2019 Jun;10(3):951-963. doi: 10.1007/s13300-019-0604-8. Epub 2019 Mar 25.
Related InfoLink provided by the sponsor.

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Not yet recruitingPhase 3
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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing empagliflozin 10mg and empagliflozin 25 mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 16 sites in Japan.

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 7 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: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 7 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment (time frame: 52 weeks). 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 NCT02589626, 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 7 Jan 2019.