Diabetes Mellitus, Type 2Phase 3NCT01947855

Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing Empagliflozin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 2 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

To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment. Read more about this study

Who is it for?: Ages 20 to 74 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Empagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 2 sitesJapan
Study dates: Sep 2013to Dec 2013
Phase: Phase 3
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 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are:
drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
pre-treated with one oral antidiabetic drug (except sulfonylurea and thiazolidinedione); the present antidiabetic therapy has to be unchanged for at least 12 weeks prior to the informed consent. (Sulfonylurea is permitted as pre-treatment drug only if the dose is equal or less than a half of daily maximum approval dose.)
Glycosylated haemoglobin (HbA1c) at Visit 1 (screening)
for patients without antidiabetic therapy : HbA1c >=7.0 to =<10.0%
for patients with one oral antidiabetic drug : HbA1c >=7.0 to =<9.5%

Who cannot join

Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (MDRD) formula)
Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

1245.35.002 Boehringer Ingelheim Investigational Site
Shinjyuku-ku, Tokyo
1245.35.001 Boehringer Ingelheim Investigational Site
Suita-shi, Osaka

Other trials in Japan

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, 4-week Study to Evaluate the Efficacy of Empagliflozin (10 mg and 25 mg Administered Orally Once Daily) in Postprandial Glucose and 24-hour Glucose Variability in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo, Empagliflozin
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.

PlaceboDrug
Placebo tablet matching Empagliflozin low dose
EmpagliflozinDrug
Empagliflozin low dose
PlaceboDrug
Placebo tablet matching Empagliflozin high dose
PlaceboDrug
Placebo tablet matching Empagliflozin low dose
EmpagliflozinDrug
Empagliflozin high dose tablet once daily
PlaceboDrug
Placebo tablet matching Empagliflozin high dose

Study groups in NCT01947855
Study group	Role	What they receive
Empagliflozin low dose	Experimental	Empagliflozin low dose tablet once daily Receives: Drug: Empagliflozin; Drug: Placebo
Empagliflozin high dose	Experimental	Empagliflozin high dose tablet once daily Receives: Drug: Placebo; Drug: Empagliflozin
Placebo	Placebo comparator	Placebo tablet once daily Receives: Drug: Placebo

What is being measured

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

Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment
The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.
Measured: 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28

Timeline

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

Sep 2013Dec 2013

First posted23 Sep 2013 (estimated)
Study startSep 2013
Primary completionDec 2013
Study completionDec 2013

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 (3)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01947855
Sponsor's protocol ID: 1245.35
Status last verified: Dec 2014
First submitted: 18 Sep 2013
Last updated: 24 Dec 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
PubMed 35472672
Nishimura R, Tanaka Y, Koiwai K, Ishida K, Salsali A, Kaspers S, Kohler S, Lund SS. Effect of Empagliflozin on Free Fatty Acids and Ketone Bodies in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial. Adv Ther. 2019 Oct;36(10):2769-2782. doi: 10.1007/s12325-019-01045-x. Epub 2019 Aug 23.
PubMed 31444706
Nishimura R, Tanaka Y, Koiwai K, Inoue K, Hach T, Salsali A, Lund SS, Broedl UC. Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study. Cardiovasc Diabetol. 2015 Jan 30;14:11. doi: 10.1186/s12933-014-0169-9.
PubMed 25633683

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?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, 4-week Study to Evaluate the Efficacy of Empagliflozin (10 mg and 25 mg Administered Orally Once Daily) in Postprandial Glucose and 24-hour Glucose Variability in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
ClinicalTrials.gov ID: NCT01947855
Acronym / sponsor ID: 1245.35
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Sep 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 23 Sep 2013 (estimated)
Results: Posted 24 Dec 2014

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: 3

Arm	Type	Receives
Empagliflozin low dose	Experimental	Drug: Empagliflozin, Drug: PlaceboEmpagliflozin low dose tablet once daily
Empagliflozin high dose	Experimental	Drug: Placebo, Drug: EmpagliflozinEmpagliflozin high dose tablet once daily
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablet once daily

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are:
Glycosylated haemoglobin (HbA1c) at Visit 1 (screening)

Key exclusion criteria (4 listed)

Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (MDRD) formula)
Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

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
PlaceboPlacebo tablet matching Empagliflozin low dose	Drug	Empagliflozin high dose
EmpagliflozinEmpagliflozin low dose	Drug	Empagliflozin low dose
PlaceboPlacebo tablet matching Empagliflozin high dose	Drug	Placebo
PlaceboPlacebo tablet matching Empagliflozin low dose	Drug	Placebo
EmpagliflozinEmpagliflozin high dose tablet once daily	Drug	Empagliflozin high dose
PlaceboPlacebo tablet matching Empagliflozin high dose	Drug	Empagliflozin low dose

Primary outcome

Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment
Time frame: 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28
The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.

Results and safety

Results posted to the registry on 24 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	21	20
Empagliflozin 10 mg	20	20
Empagliflozin 25 mg	19	19

Primary outcome: Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment

Time frame: 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28. Least squares mean (Standard Error). Unit: mg*h/dL

Measure	Placebo n = 20	Empagliflozin 10 mg n = 20	Empagliflozin 25 mg n = 19
Value	-18.07 (13.89)	-103.56 (14.24)	-122.94 (14.35)

Placebo vs Empagliflozin 25 mg: Mean Difference (Net): -104.87 (95% CI -144.77 to -64.97), p <0.0001, ANCOVA
Placebo vs Empagliflozin 10 mg: Mean Difference (Net): -85.49 (95% CI -126.01 to -44.97), p <0.0001, ANCOVA

Population analysed: Full analysis set

Adverse events

Time frame: between the first drug intake of study medication and 7 days after last drug intake of study medication, up to 35 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 21 (0%)	1 of 21 (4.8%)	Not reported
Empagliflozin 10 mg	0 of 20 (0%)	2 of 20 (10%)	Not reported
Empagliflozin 25 mg	0 of 19 (0%)	3 of 19 (15.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35472672Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
Derived from this study: PubMed 31444706Nishimura R, Tanaka Y, Koiwai K, Ishida K, Salsali A, Kaspers S, Kohler S, Lund SS. Effect of Empagliflozin on Free Fatty Acids and Ketone Bodies in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial. Adv Ther. 2019 Oct;36(10):2769-2782. doi: 10.1007/s12325-019-01045-x. Epub 2019 Aug 23.
Derived from this study: PubMed 25633683Nishimura R, Tanaka Y, Koiwai K, Inoue K, Hach T, Salsali A, Lund SS, Broedl UC. Effect of empagliflozin monotherapy on postprandial glucose and 24-hour glucose variability in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, 4-week study. Cardiovasc Diabetol. 2015 Jan 30;14:11. doi: 10.1186/s12933-014-0169-9.
Related InfoLink provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 2 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 4 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 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 Dec 2014). 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?

Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment (time frame: 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28). 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 NCT01947855, which also lists 3 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 24 Dec 2014.