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Diabetes Mellitus, Type 2Phase 3NCT02489968

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus

A Phase 3 study testing empagliflozin 10 mg + linagliptin 5 mg, empagliflozin 10 mg and empagliflozin 25 mg + linagliptin 5 mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 83 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg + linagliptin. All analyses will be carried out separately for these study parts. 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 10 mg + linagliptin 5 mg, empagliflozin 10 mg and empagliflozin 25 mg + linagliptin 5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
880 participants
Where
83 sitesJapan
Study dates
12 May 2015to 16 Jun 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of type 2 diabetes prior to informed consent
  • Male and female patients on diet and exercise regimen for at least 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 (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). Individual antidiabetic drug will have to be discontinued at Visit 1.
  • haemoglobin A1c (HbA1c) at Visit 1 (screening)
  • for patients without antidiabetic therapy : HbA1c >=8.0 to =<10.5%
  • for patients with one oral antidiabetic drug : HbA1c >=7.5 to =<10.5%
  • HbA1c >=7.5 to =<10.0% at Visit 4 for randomisation into the double blind treatment period

Who cannot join

  • Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15.0 mmol/L) during the open label stabilisation period and placebo run in period
  • Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (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

83 sites in 1 country.

83 sites in 1 country

Japan83 sites

  • Tokai Memorial Hospital

    Aichi, Kasugai, 487-0031

  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital

    Aichi, Nagoya, 455-8530

  • Tokuyama Clinic

    Chiba, Chiba, 261-0004

  • Matsuyama Shimin Hospital

    Ehime, Matsuyama, 790-0067

  • Tanaka Int. Clinic, Ehime, DIA Med.,CV Med.

    Ehime, Niihama, 792-0045

  • Murakami Memorial Hp., Ehime, I.M.

    Ehime, Saijo, 793-0030

  • Kunisaki Makoto Clinic, Fukuoka, I.M./CV Med.

    Fukuoka, Fukuoka, 819-0168

  • Fukuoka Shin Mizumaki Hospital

    Fukuoka, Onga, 807-0051

  • Shin Yukuhashi Hospital

    Fukuoka, Yukuhashi, 824-0026

  • Hashimoto I.M., Gifu, I.M.

    Gifu, Gifu, 500-8225

  • Kikuchi Naika Clinic, Gunma, I.M.

    Gunma, Maebashi, 370-3573

  • Hasegawa Internal Medicine Clinic

    Hokkaido, Chitose, 066-0032

  • Ebetsu Internal Medicine Clinic

    Hokkaido, Ebetsu, 067-0041

  • Hakodate Koseiin Hakodate Central General Hospital

    Hokkaido, Hakodate, 040-8585

  • Iida Medical Clinic

    Hokkaido, Hakodate, 042-0942

  • Kurihara Clinic

    Hokkaido, Sapporo, 004-0053

  • Uehara Clinic

    Hokkaido, Sapporo, 006-0031

  • Manda Memorial Hospital

    Hokkaido, Sapporo, 060-0062

  • Sapporo Diabetes, Thyroid Clinic

    Hokkaido, Sapporo, 060-0807

  • Japan Community Health Care Organization Hokkaido Hospital

    Hokkaido, Sapporo, 062-8618

  • Ashiya Municipal Hospital

    Hyogo, Ashiya, 659-8502

  • Itabashi DIA Med. and DERM Clinic, Ibaraki, I.M.

    Ibaraki, Koga, 306-0232

  • Namegata District General Hospital

    Ibaraki, Namegata, 311-3516

  • Hokuriku Hp., Ishikawa, I.M.

    Ishikawa, Kanazawa, 921-8035

  • Oikawa Clinic

    Iwate, Morioka, 020-0066

  • Hirano Medical Clinic

    Iwate, Morioka, 020-0132

  • Iwamoto Clinic, Kagawa, DIAB I.M.

    Kagawa, Zentsuji, 765-0071

  • Tenpozan Clinic of I.M., Kagoshima, I.M.

    Kagoshima, Kagoshima, 890-0061

  • Hayashi DIA Clinic, Kanagawa, DIA Tract Med.·I.M.

    Kanagawa, Chigasaki, 253-0044

  • Takai Naika Clinic

    Kanagawa, Kamakura, 247-0056

  • Nagatsuta Family Clinic, Kanagawa, I.M.

    Kanagawa, Yokohama, 226-0027

  • Motomachi Takatsuka Naika Clinic, Kanagawa, I.M.

    Kanagawa, Yokohama, 231-0023

  • Yokohama Minoru Clinic

    Kanagawa, Yokohama, 232-0064

  • Morinagaueno clinic, Kumamoto, Digestive Tract I.M.

    Kumamoto, Kumamoto, 860-0863

  • Kumamoto University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Jinnouchi Clinic Diabetes Care Center

    Kumamoto, Kumamoto, 862-0976

  • Kajiyama Clinic, Kyoto, I.M.

    Kyoto, Kyoto, 615-0035

  • Matsumoto Nakagawa Hospital

    Nagano, Matsumoto, 399-0006

  • Ota DIA I.M. Clinic, Nagano, I.M.

    Nagano, Nagano, 380-0802

  • Saiseikai Niigata Daini Hp., Niigata, METAB ENDO

    Niigata, Niigata, 950-1104

  • Tsuyama Chuo Hospital

    Okayama, Tsuyama, 708-0841

  • Yaesu Clinic, Okinawa, I.M.

    Okinawa, Naha, 900-0032

  • Tanaka Clinic, Okinawa, I.M.

    Okinawa, Tomigusuku, 901-0244

  • AMC Nishi-umeda Clinic

    Osaka, 530-0001

  • Shiraiwa Medical Clinic, Osaka, I.M.

    Osaka, 582-0005

  • Umeda Oak Clinic, Osaka, I.M.

    Osaka, Osaka, 530-0057

  • Kinugawa CARDIOL Clinic, Osaka, I.M.

    Osaka, Osaka, 532-0026

  • Ikeoka Clinic, Osaka, I.M.

    Osaka, Osaka, 536-0008

  • Nanko Clinic, Osaka, I.M.

    Osaka, Osaka, 559-0011

  • OCROM Clinic

    Osaka, Suita, 565-0853

  • Saga Memorial Hospital

    Saga, Saga, 849-0917

  • Odayaka Life Naika Clinic, Saitama, I.M.

    Saitama, Koshigaya, 343-0828

  • Medical corporation Chisei-kai Watanabe clinic

    Saitama, Okegawa, 363-0022

  • Medical Corporation Toujinkai Sakado Central Hospital

    Saitama, Sakado, 350-0233

  • SAINO Clinic,

    Saitama, Tokorozawa, 359-1141

  • Hamamatsu Rosai Hospital

    Shizuoka, Hamamatsu, 430-8525

  • Plumeria Clinic, Shizuoka, I.M.

    Shizuoka, Shizuoka, 422-8006

  • Wakakusa Clinic, Tochigi, I.M.

    Tochigi, Shimotsuke, 329-0433

  • Kanda Clinic, Tokyo, I.M.

    Tokyo, 101-0047

  • Nihonbashi Sakura Clinic

    Tokyo, Chuo-ku, 103-0025

  • Fukuwa Clinic

    Tokyo, Chuo-ku, 103-0027

  • Nihonbashi Enomoto Internal Medicine

    Tokyo, Chuo-ku, 103-0027

  • Tokyo-Eki Center-building Clinic

    Tokyo, Chuo-ku, 103-0027

  • Tokyo Center Clinic

    Tokyo, Chuo-ku, 103-0028

  • Hosono Clinic

    Tokyo, Chuo-ku, 104-0031

  • AGE Makita Medical Clinic

    Tokyo, Chuo-ku, 104-0061

  • Kasai Diabetes Clinic

    Tokyo, Edogawa-ku, 134-0084

  • New Medical Research System Clinic

    Tokyo, Hachioji, 192-0046

  • Medical Corporation Keikokai P1-Clinic

    Tokyo, Hachioji, 192-0071

  • Minamino Heart Clinic

    Tokyo, Hachioji, 192-0918

  • Shinkoiwa Ekimae Sougou Clinic

    Tokyo, Katushika-ku, 124-0024

  • Musashino Polyclinic

    Tokyo, Kiyose, 204-0021

  • Pedi Shiodome Clinic

    Tokyo, Minato-ku, 105-7390

  • Shinagawa East one Medical Clinic

    Tokyo, Minato-ku, 108-0075

  • Shimamura Kinen Hospital

    Tokyo, Nerima-ku, 177-0051

  • Kenkoukan Suzuki Clinic

    Tokyo, Ota-ku, 143-0015

  • Honda Hidehiko Clinic

    Tokyo, Ota-ku, 143-0023

  • Sakayori Clinic

    Tokyo, Shinagawa-ku, 140-0011

  • Miho Clinic

    Tokyo, Shinagawa-ku, 141-0032

  • ToCROM Clinic

    Tokyo, Shinjuku-ku, 160-0022

  • Ikebukuro Metropolitan Clinic

    Tokyo, Toshima-ku, 171-0021

  • Fujikoshi Hp., Toyama, I.M.

    Toyama, Toyama, 930-0964

  • Clinic Sugiyama, Yamagata, I.M.

    Yamagata, Yamagata, 990-0885

Other trials in Japan

About this study

Official title: A Phase III, Randomised, Double-blind, Parallel Group, 24-week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and Linagliptin 5 mg Fixed Dose Combination Compared With Empagliflozin 10 mg Plus Placebo and a 52-week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 25 mg and Linagliptin 5 mg Fixed Dose Combination Compared With Empagliflozin 25 mg Plus Placebo in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16-week Treatment With Empagliflozin (10 mg or 25 mg) Alone Once Daily.

Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg + linagliptin. All analyses will be carried out separately for these study parts. The objective of Part A is to investigate the efficacy, safety and tolerability of the fixed dose combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin 10 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM (Type 2 Diabetes Mellitus) who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg plus FDC matching placebo after 24 weeks of treatment. The objective of Part B is to investigate the efficacy, safety and tolerability of the FDC of empagliflozin 25 mg / linagliptin 5 mg compared with empagliflozin 25 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 25 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over empagliflozin 25 mg plus FDC matching placebo after 24 weeks of treatment. The 24 week treatment period will be followed by a 28 week extension treatment period to evaluate further efficacy and safety up to 52 weeks.

Being tested
empagliflozin 10 mg + linagliptin 5 mg, empagliflozin 10 mg, empagliflozin 25 mg + linagliptin 5 mg, 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 10 mg + linagliptin 5 mgDrug

    empagliflozin low dose + linagliptin once daily

  • empagliflozin 10 mgDrug

    empagliflozin low dose once daily

  • empagliflozin 25 mg + linagliptin 5 mgDrug

    empagliflozin high dose + linagliptin once daily

  • empagliflozin 25 mgDrug

    empagliflozin high dose once daily

  • PlaceboDrug

Study groups in NCT02489968
Study groupRoleWhat they receive
empagliflozin 10 mg + linagliptin 5 mgExperimentalpatient to receive a tablet containing low dose empagliflozin and linagliptin once daily
Receives: Drug: empagliflozin 10 mg + linagliptin 5 mg
empagliflozin 10 mgExperimentalpatient to receive a tablet containing low dose empagliflozin once daily
Receives: Drug: empagliflozin 10 mg; Drug: Placebo
empagliflozin 25 mg + linagliptin 5 mgExperimentalpatient to receive a tablet containing high dose empagliflozin and linagliptin once daily
Receives: Drug: empagliflozin 25 mg + linagliptin 5 mg
empagliflozin 25 mgExperimentalpatients to receive a tablet containing high dose empagliflozin once daily
Receives: Drug: empagliflozin 25 mg; Drug: Placebo

What is being measured

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

  1. Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment

    Change from baseline in HbA1c (%) after 24 weeks of treatment with double-blind trial medication. Change was calculated as: HbA1c value at 24-week - HbA1c value at baseline, for each patient. Baseline was defined as the last observation before the first intake of double-blind randomised trial medication. Statistical analysis presented is based on a restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach. Full Analysis Set (Observed Cases) [FAS (OC)]: This analysis set consisted of all patients who were randomised and treated with at least 1 dose of trial drug during the double-blind part of the trial and who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the 24-week double-blind part of the trial. Observed cases analysis included only the available data that were observed while patients were on treatment, i.e., excluding the missing data.

    Measured: Baseline and 24 week

Timeline

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

  1. First posted3 Jul 2015 (estimated)
  2. Study start12 May 2015
  3. Primary completion18 Nov 2016
  4. Study completion16 Jun 2017

Resources

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
Who is masked
Participant, Investigator
Enrolment
880 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02489968
Sponsor's protocol ID
1275.13
Status last verified
Sep 2018
First submitted
27 May 2015
Last updated
6 Sep 2018

Publications

  • Kaku K, Haneda M, Tanaka Y, Lee G, Shiki K, Miyamoto Y, Solimando F, Lee J, Lee C, George J. Linagliptin as add-on to empagliflozin in a fixed-dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a two-part, randomized, placebo-controlled trial. Diabetes Obes Metab. 2019 Jan;21(1):136-145. doi: 10.1111/dom.13496. Epub 2018 Sep 6.

    PubMed 30091172

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing empagliflozin 10 mg + linagliptin 5 mg, empagliflozin 10 mg and empagliflozin 25 mg + linagliptin 5 mg in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 83 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 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 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 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 6 Sep 2018). 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 Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment (time frame: Baseline 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 NCT02489968, 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 6 Sep 2018.

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