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

24 settembre 2018 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

275

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

20 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Linagliptin
patient to receive 5 mg linagliptin once daily
Droga: Linagliptin
Altri nomi:
  • tavoletta
Droga: Empagliflozin placebo + linagliptin placebo low dose
Matching placebo empagliflozin + linagliptin
Droga: Empa + lina highdose placebo
Sperimentale: Empagliflozin + linagliptin low dose
patient to receive one tablet once daily
Droga: Empagliflozin + linagliptin low dose
tablet
Droga: Linagliptin placebo
Matching placebo linagliptin
Sperimentale: Empagliflozin + linagliptin high dose
patient to receive one tablet once daily
Droga: Linagliptin placebo
Matching placebo linagliptin
Droga: Empagliflozin + linagliptin high dose
tablet
Comparatore placebo: Linagliptin placebo
Droga: Empagliflozin + linagliptin low dose
tablet
Droga: Linagliptin placebo
Matching placebo linagliptin
Droga: Empagliflozin + linagliptin high dose
tablet
Comparatore placebo: Empagliflozin + linagliptin high dose placebo
Droga: Linagliptin
Altri nomi:
  • tavoletta
Droga: Empa + lina highdose placebo
Comparatore placebo: Empagliflozin + linagliptin low dose placebo
Droga: Linagliptin
Altri nomi:
  • tavoletta
Droga: Empagliflozin placebo + linagliptin placebo low dose
Matching placebo empagliflozin + linagliptin

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in HbA1c From Week 28 at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Only)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Collaboratori

Eli Lilly and Company

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 maggio 2015

Completamento primario (Effettivo)

26 agosto 2016

Completamento dello studio (Effettivo)

27 marzo 2017

Date di iscrizione allo studio

Primo inviato

21 maggio 2015

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2015

Primo Inserito (Stima)

25 maggio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 febbraio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2018

Ultimo verificato

1 settembre 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1275.19

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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