Diabetes Mellitus, Type 2Phase 4NCT02589639
Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Empagliflozin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 48 sites in Japan.
Trial summary
This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 269 participants
- Where
- 48 sitesJapan
- Study dates
- 28 Oct 2015to 5 Jan 2018
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes mellitus
- Patients on diet and exercise regimen who are pre-treated with any insulin therapy alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to screening
- Fasting C-peptide must be > 0.5 ng/mL
- HbA1c at screening in Patients who are treated with insulin alone must be >=7.5% and <=10.0%
- HbA1c in Patients who are treated with insulin with 1 oral antidiabetic drug (OAD) must be >=7.0% and <=9.5% at screening, and >=7.5% and <=10.0% at placebo run-in period
- Age at informed consent must be >=20 and <75 years
- BMI at screening must be >22 and <=40 kg/m2
- Further inclusion criteria apply
Who cannot join
- Patients who experience uncontrolled hyperglycaemia before randomization
- Patients who are treated with sulfonylurea whose dose is more than a half of daily maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and sodium-glucose co-transporter 2 (SGLT-2) inhibitor
- Patients with recent cardiovascular and/or stroke events
- Patients with hepatic and/or renal dysfunction
- Patients who received anti-obesity drugs or other treatment leading to unstable body weight
- Patients who have known allergy or hypersensitivity to insulin and/or empagliflozin
- Pre-menopausal women who are nursing or pregnant
- Further exclusion criteria apply
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
Japan48 sites
Nakayama Clinic
Aichi, 456-0058
Kashiwa City Hospital
Chiba, Kashiwa, 277-0825
Kunisaki Makoto Clinic
Fukuoka, 819-0168
Saiseikai Fukuoka General Hospital
Fukuoka, Fukuoka, 810-0001
Seiwakai Medical Corporation Nagata Hospital
Fukuoka, Yanagawa, 832-0059
Saiseikai Maebashi Hospital
Gunma, Maebashi, 371-0821
Nippon Kokan Fukuyama Hospital
Hiroshima, Fukuyama, 721-0927
Jiyugaoka Yokoyama Naika Clinic
Hokkaido, Obihiro, 080-0016
Jiyugaoka Yamada Clinic
Hokkaido, Obihiro, 080-0848
Souen Diabetes Clinic
Hokkaido, Sapporo, 060-0011
Kotani Diabetes Clinic
Hyogo, Kobe, 657-0028
Nishinomiya Municipal Central Hospital
Hyogo, Nishinomiya, 663-8014
Noritake Clinic
Ibaraki, Ushiku, 300-1207
Yokoi Medical Clinic, Kagawa, I.M.
Kagawa, 761-8075
Fukumoto clinic
Kagoshima, 891-0401
Izuro Imamura Hospital
Kagoshima, Kagoshima, 892-0824
Wakamatsu Memorial Hospital
Kagoshima, Satsumasendai, 895-0052
STOP DM SUZUKI DIABETES CLINIC, Kanagawa, I.M.
Kanagawa, Atsugi, 243-0035
Takai Naika Clinic
Kanagawa, Kamakura, 247-0056
Kokan Clinic
Kanagawa, Kawasaki, 210-0852
Yoshimasa Diabetes & Endocrine Clinic
Kyoto, Kyoto, 604-8151
Medical Corporation KEISEIKAI Kajiyama clinic
Kyoto, Kyoto, 615-0035
Saka General Clinic
Miyagi, Tagajo, 985-0835
North Alps Medical Center Azumi Hospital
Nagano, Kitaazumi-gun, 399-8695
Asama Nanroku Komoro Medical center
Nagano, Komoro, 384-8588
Abe Clinic
Oita, Oita, 870-0039
Tsuyama Chuo Hospital
Okayama, Tsuyama, 708-0841
AMC Nishi-umeda Clinic
Osaka, 530-0001
Shiraiwa Medical Clinic
Osaka, 582-0005
Medical Corporation Kyojinkai Clinic Komatsu
Osaka, Neyagawa, 572-8567
Minamiosaka Hospital
Osaka, Osaka, 559-0012
OCROM Clinic
Osaka, Suita, 565-0853
Ageo Central General Hospital
Saitama, Ageo, 362-8588
Medical Corporation Kaishinkai Masunaga Clinic
Saitama, Fujimi, 354-0031
Medical Corporation Fusa Shimizu Clinic Fusa
Saitama, Saitama, 336-0963
Seiwa Clinic
Tokyo, Adachi-ku, 123-0845
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Chiyoda Houjin Clinic
Tokyo, Chiyoda-ku, 101-0024
HDC Atlas Clinic
Tokyo, Chiyoda-ku, 102-0082
Fukuwa Clinic
Tokyo, Chuo-ku, 103-0027
Tokyo-Eki Center-building Clinic
Tokyo, Chuo-ku, 103-0027
Tokyo Center Clinic
Tokyo, Chuo-ku, 103-0028
Shin Clinic
Tokyo, Ota-ku, 144-0051
Shinjuku Research Park Clinic
Tokyo, Shinjuku-ku, 169-0073
Sumida Chuou Hospital
Tokyo, Sumida-ku, 131-0046
Sagae City Hospital
Yamagata, Sagae, 991-8508
Clinic Sugiyama
Yamagata, Yamagata, 990-0885
Yamanashi Prefectural Central Hospital
Yamanashi, Kofu, 400-8506
About this study
Official title: A 52-week Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Empagliflozin Once Daily, as an add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Empagliflozin, 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.
EmpagliflozinDrug
PlaceboDrug
PlaceboDrug
For blinding purposes
| Study group | Role | What they receive |
|---|---|---|
| empagliflozin 10 mg | Experimental | Not described Receives: Drug: Empagliflozin; Drug: Placebo |
| empagliflozin 25 mg | Experimental | Not described Receives: Drug: Empagliflozin; Drug: Placebo |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.
The primary endpoint was the change from baseline in HbA1c after 16 weeks of treatment.
The term "baseline" refers to the last observation prior to the administration of any randomised study drug.
Means presented are the adjusted means.
Measured: Baseline and 16 weeks
Secondary outcomes (1)
Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs)
Percentage of patients with investigator defined drug-related Adverse Events (AEs) are presented
Measured: From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start28 Oct 2015
- Primary completion18 Apr 2017
- Study completion5 Jan 2018
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
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589639
- Sponsor's protocol ID
- 1245.107
- Status last verified
- Dec 2018
- First submitted
- 27 Oct 2015
- Last updated
- 27 Mar 2019
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Empagliflozin Once Daily, as an add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
- ClinicalTrials.gov ID
- NCT02589639
- Acronym / sponsor ID
- 1245.107
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 18 Apr 2017 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Posted 27 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| empagliflozin 10 mg | Experimental | Drug: Empagliflozin, Drug: Placebo |
| empagliflozin 25 mg | Experimental | Drug: Empagliflozin, Drug: Placebo |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of type 2 diabetes mellitus
- Patients on diet and exercise regimen who are pre-treated with any insulin therapy alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to screening
- Fasting C-peptide must be > 0.5 ng/mL
- HbA1c at screening in Patients who are treated with insulin alone must be >=7.5% and <=10.0%
- HbA1c in Patients who are treated with insulin with 1 oral antidiabetic drug (OAD) must be >=7.0% and <=9.5% at screening, and >=7.5% and <=10.0% at placebo run-in period
Key exclusion criteria (8 listed)
- Patients who experience uncontrolled hyperglycaemia before randomization
- Patients who are treated with sulfonylurea whose dose is more than a half of daily maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and sodium-glucose co-transporter 2 (SGLT-2) inhibitor
- Patients with recent cardiovascular and/or stroke events
- Patients with hepatic and/or renal dysfunction
- Patients who received anti-obesity drugs or other treatment leading to unstable body weight
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 | Drug | empagliflozin 10 mg, empagliflozin 25 mg |
| Placebo | Drug | placebo |
| PlaceboFor blinding purposes | Drug | empagliflozin 10 mg, empagliflozin 25 mg, placebo |
Primary outcome
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.
Time frame: Baseline and 16 weeks
The primary endpoint was the change from baseline in HbA1c after 16 weeks of treatment. The term "baseline" refers to the last observation prior to the administration of any randomised study drug. Means presented are the adjusted means.
1 secondary outcome
Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs)
Time frame: From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- 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.
- 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
48 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 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 48 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 8 inclusion and 8 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 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 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 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 27 Mar 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?
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment. (time frame: Baseline and 16 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 NCT02589639, 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 27 Mar 2019.