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Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus

24 września 2018 zaktualizowane przez: Boehringer Ingelheim

A Phase III, Randomised, Double-blind, Parallel Group, 52 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin and Linagliptin Fixed Dose Combination Compared With Linagliptin Plus Placebo in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control After 16 Weeks Treatment With Once Daily Linagliptin 5 mg.

This trial will compare the use of fixed dose combination of empagliflozin and linagliptin to linagliptin alone in patient with type 2 diabetes mellitus

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

275

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Japonia
      • Aichi, Nagoya, Japonia, 454-0933
        • Nagoya Kyoritsu Hospital
      • Chiba, Kashiwa, Japonia, 277-0825
        • Kashiwa City Hospital
      • Fukuoka, Fukuoka, Japonia, 811-1346
        • Otabe internal medicine clinic
      • Fukuoka, Itoshima, Japonia, 819-1104
        • Nakamura Cardiovascular Clinic
      • Fukuoka, Kurume, Japonia, 830-0023
        • Tanaka I.M. Clinic, Fukuoka, I.M.
      • Fukushima, Koriyama, Japonia, 963-8851
        • Seino I.M. Clinic, Fukushima, I.M.
      • Hiroshima, Hiroshima, Japonia, 733-0011
        • Hiraoka Naika Clinic, Hiroshima, I.M.
      • Hokkaido, Sapporo, Japonia, 003-0026
        • Matsuda Cardiovascular Clinic
      • Hokkaido, Sapporo, Japonia, 006-0811
        • Teine Keijinkai Clinic
      • Hokkaido, Sapporo, Japonia, 006-0852
        • Mita Internal Medicine Cardiology Clinic
      • Hokkaido, Sapporo, Japonia, 063-0826
        • Miyanosawa Clinic of Internal Medicine and Cardiology
      • Ibaraki, Koga, Japonia, 306-0232
        • Itabashi Diabetic medicine and Dermatology Clinic
      • Ibaraki, Naka, Japonia, 311-0113
        • Nakakinen clinic
      • Kanagawa, Kawasaki, Japonia, 214-0014
        • Kubota Clinic
      • Kanagawa, Sagamihara, Japonia, 252-0375
        • Kitasato University Hospital
      • Kanagawa, Yokohama, Japonia, 235-0045
        • H.E.C Science Clinic
      • Kyoto, Kyoto, Japonia, 604-8151
        • Yoshimasa Diabetes & Endocrine Clinic
      • Kyoto, Kyoto, Japonia, 615-8125
        • Medical Corporation Hayashi Katagihara Clinic
      • Kyoto, Kyoto, Japonia, 607-8062
        • Rakuwakai Otowa Hospital
      • Nagano, Matsumoto, Japonia, 390-0848
        • Miyamoto Naika Clinic, Nagano, I.M.
      • Nagano, Matsumoto, Japonia, 399-0036
        • Gibo Hepatology Clinic, Nagano, Digestive Tract I.M.
      • Osaka, Higashi-Osaka, Japonia, 577-0803
        • Takekawa Clinic, Osaka, I.M.
      • Osaka, Osaka, Japonia, 532-0003
        • Medical Corporation Koseikai Fukuda Naika Clinic
      • Osaka, Osaka, Japonia, 532-0026
        • Kinugawa Cardiovascular Internal Medicine clinic
      • Osaka, Osaka, Japonia, 536-0023
        • Sato Hospital
      • Osaka, Osaka, Japonia, 555-0032
        • Nakaoka Clinic
      • Osaka, Suita, Japonia, 565-0853
        • OCROM Clinic
      • Osaka, Takatsuki, Japonia, 569-1123
        • Miyauchi Medical Center
      • Saitama, Hanno, Japonia, 357-0024
        • Medical Corporation Shinseikai Mashiba Clinic
      • Saitama, Kawagoe, Japonia, 350-0851
        • Asano Clinic
      • Saitama, Saitama, Japonia, 336-0963
        • Medical Corporation Fusa Shimizu Clinic Fusa
      • Saitama, Tokorozawa, Japonia, 359-1161
        • Ogino Clinic
      • Tokyo, Chiyoda-ku, Japonia, 101-0047
        • Kanda Clinic
      • Tokyo, Chuo-ku, Japonia, 103-0027
        • Fukuwa Clinic
      • Tokyo, Chuo-ku, Japonia, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Tokyo, Hachioji, Japonia, 192-0046
        • Myojin Tou Clinic
      • Tokyo, Koto-ku, Japonia, 136-0073
        • Sawai Medical Clinic
      • Tokyo, Meguro-ku, Japonia, 153-0051
        • Mishuku Hospital
      • Tokyo, Shinagawa-ku, Japonia, 140-8522
        • Toshiba General Hospital
      • Tokyo, Shinjuku-ku, Japonia, 160-0022
        • ToCROM Clinic

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion criteria:

  1. Diagnosis of Type-2 Diabetes Mellitus (T2DM) prior to informed consent

  2. Male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:

    • 1 drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent, or
    • 2 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 informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent, for linagliptin 5 mg at least 16 weeks prior to Visit 1). Individual antidiabetic drug (except linagliptin) will have to be discontinued at Visit 1.

  3. HbA1c at Visit 1

    • 1 HbA1c =8.0% and =10.5% for patients who are drug-naïve, or
    • 2 HbA1c =7.5% and =10.5% for patients with one oral antidiabetic drug (except linagliptin), or
    • 3 HbA1c =7.5% and =10.0% for patients with linagliptin 5 mg
  4. HbA1c =7.5% and =10.0% at Visit 4 for randomisation into the double-blind treatment period. Patient who are pre-treated with linagliptin 5 mg for 16 weeks or more prior to Visit 1 and meet the criteria of HbA1c can directly move on to the run-in (Visit 4).
  5. Age =20 years at informed consent
  6. BMI =40.0 kg/m2 at Visit 1 (screening)
  7. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

  1. Uncontrolled hyperglycemia with a glucose level >270 mg/dL (>15.0 mmol/L) after an overnight fast during the open-label stabilisation period (from Visit 2 to Visit 4) and run-in period (from Visit 4 to Visit 5) , confirmed by a second measurement (not on the same day and done either at the central or at local laboratory).
  2. Acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 12 weeks prior to informed consent
  3. Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT Serum glutamic pyruvate transaminase [SGPT]), aspartate aminotransferase (AST, Serum glutamic oxaloacetic transaminase [SGOT]), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN) as determined during screening, open-label stabilisation period and/or run-in period
  4. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 (MDRD formula) as determined during screening, open-label stabilisation period and/or run-in period
  5. Known hereditary galactose intolerance
  6. Known contraindications to linagliptin and empagliflozin according to the Japanese label
  7. Any previous (within 2 years prior to informed consent) or planned bariatric surgery (or any other weight loss surgery) or other gastrointestinal surgery that induce chronic malabsorption
  8. Medical history of cancer (except for resected non-invasive basal cell or squamous carcinoma) and/or treatment for cancer within the last 5 years
  9. Known blood dyscrasias or any disorders causing haemolysis or unstable red blood cell (RBC) count (e.g. malaria, babesiosis, haemolytic anaemia).
  10. Treatment with insulin, Glucagon-like peptide-1 agonists, within 12 weeks prior to informed consent
  11. Treatment with anti-obesity drugs within 12 weeks prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight
  12. Current treatment with systemic steroids (other than inhaled or topical steroids) at informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM

  13. Pre-menopausal women (last menstruation =1 year prior to informed consent) who:

    • 1 are nursing or pregnant or
    • 2 are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, intra uterine devices/systems, oral contraceptives, complete sexual abstinence, double barrier method and vasectomised partner
  14. Known or suspected allergy or hypersensitivity to trial products or related products (e.g., Dipeptidyl-peptidase-4 inhibitors or Sodium-glucose co-transporter-2 inhibitors)
  15. Alcohol or drug abuse within the 12 weeks prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to trial procedures or trial drug intake, by the judgment of the investigator
  16. Intake of an investigational drug in another trial within 30 days prior to Visit 1 or participation in the follow-up period of another trial (participation in observational studies is permitted)
  17. Any other clinical condition that, in the opinion of the investigator, would jeopardize patient's safety while participating in this clinical trial

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Linagliptin
patient to receive 5 mg linagliptin once daily
Lek: Linagliptyna
Inne nazwy:
  • tablet
Lek: Empagliflozin placebo + linagliptin placebo low dose
Matching placebo empagliflozin + linagliptin
Lek: Empa + lina highdose placebo
Eksperymentalny: Empagliflozin + linagliptin low dose
patient to receive one tablet once daily
Lek: Empagliflozin + linagliptin low dose
tablet
Lek: Linagliptin placebo
Matching placebo linagliptin
Eksperymentalny: Empagliflozin + linagliptin high dose
patient to receive one tablet once daily
Lek: Linagliptin placebo
Matching placebo linagliptin
Lek: Empagliflozin + linagliptin high dose
tablet
Komparator placebo: Linagliptin placebo
Lek: Empagliflozin + linagliptin low dose
tablet
Lek: Linagliptin placebo
Matching placebo linagliptin
Lek: Empagliflozin + linagliptin high dose
tablet
Komparator placebo: Empagliflozin + linagliptin high dose placebo
Lek: Linagliptyna
Inne nazwy:
  • tablet
Lek: Empa + lina highdose placebo
Komparator placebo: Empagliflozin + linagliptin low dose placebo
Lek: Linagliptyna
Inne nazwy:
  • tablet
Lek: Empagliflozin placebo + linagliptin placebo low dose
Matching placebo empagliflozin + linagliptin

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline)
Ramy czasowe: Baseline and 24 week
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) at Week 24 was calculated as: HbA1c at Week 24 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Baseline and 24 week

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in HbA1c From Week 28 at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Only)
Ramy czasowe: 28 Week (pre up-titration) and 52 Week

Change from Week 28 in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at Week 28. Week 28 (pre up-titration) is referred to the last observed measurement prior to the first administration of any double-blind randomized trial medication in the up-titration period. Adjusted mean (Least square mean) and its standard error (SE) is presented.

This endpoint was based on 1 group of the Full analysis set with up-titration (FASUT-II) whose dose was up-titrated to Empagliflozin 25 mg/Linagliptin 5 mg fixed dose combination thus there is no comparison group. Hence, no comparison is made. A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline eGFR, prior use of antidiabetic drug, visit as fixed effect(s). The covariance used to fit the model was unstructured.
28 Week (pre up-titration) and 52 Week
Change in HbA1c From Baseline at Week 52 (All Empagliflozin Versus All Placebo)
Ramy czasowe: Baseline and 52 week
Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Baseline and 52 week
Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus Linagliptin 5 mg + Placebo 25 mg)
Ramy czasowe: Baseline and 52 week
Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Baseline and 52 week
Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus All Placebo)
Ramy czasowe: Baseline and 52 week
Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Baseline and 52 week

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Boehringer Ingelheim

Współpracownicy

Eli Lilly and Company

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

14 maja 2015

Zakończenie podstawowe (Rzeczywisty)

26 sierpnia 2016

Ukończenie studiów (Rzeczywisty)

27 marca 2017

Daty rejestracji na studia

Pierwszy przesłany

21 maja 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 maja 2015

Pierwszy wysłany (Oszacować)

25 maja 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 lutego 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 września 2018

Ostatnia weryfikacja

1 września 2018

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1275.19

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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