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Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment

6. marts 2019 opdateret af: Novo Nordisk A/S

Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment.

The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

279

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Den Russiske Føderation
      • Barnaul, Den Russiske Føderation, 656045
        • Novo Nordisk Investigational Site
      • Kazan, Den Russiske Føderation, 420043
        • Novo Nordisk Investigational Site
      • Kursk, Den Russiske Føderation, 305035
        • Novo Nordisk Investigational Site
      • Moscow, Den Russiske Føderation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Den Russiske Føderation, 123448
        • Novo Nordisk Investigational Site
      • Moscow, Den Russiske Føderation, 127411
        • Novo Nordisk Investigational Site
      • Nizhniy Novgorod, Den Russiske Føderation, 603126
        • Novo Nordisk Investigational Site
      • Penza, Den Russiske Føderation, 440026
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Den Russiske Føderation, 195257
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Den Russiske Føderation, 194358
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Den Russiske Føderation, 199034
        • Novo Nordisk Investigational Site
      • Samara, Den Russiske Føderation, 443067
        • Novo Nordisk Investigational Site
      • Saratov, Den Russiske Føderation, 410039
        • Novo Nordisk Investigational Site
      • Saratov, Den Russiske Føderation, 410053
        • Novo Nordisk Investigational Site
      • Saratov, Den Russiske Føderation, 410031
        • Novo Nordisk Investigational Site
      • Smolensk, Den Russiske Føderation, 214019
        • Novo Nordisk Investigational Site
      • Volgograd, Den Russiske Føderation, 400138
        • Novo Nordisk Investigational Site
  • Det Forenede Kongerige
      • Bristol, Det Forenede Kongerige, BS10 5NB
        • Novo Nordisk Investigational Site
      • Dundee, Det Forenede Kongerige, DD1 9SY
        • Novo Nordisk Investigational Site
      • Edinburgh, Det Forenede Kongerige, EH4 2XU
        • Novo Nordisk Investigational Site
      • Hull, Det Forenede Kongerige, HU3 2RW
        • Novo Nordisk Investigational Site
      • Leicester, Det Forenede Kongerige, LE5 4PW
        • Novo Nordisk Investigational Site
      • Letchworth, Det Forenede Kongerige, SG6 4UB
        • Novo Nordisk Investigational Site
      • London, Det Forenede Kongerige, E1 2EF
        • Novo Nordisk Investigational Site
      • London, Det Forenede Kongerige, SE5 9RT
        • Novo Nordisk Investigational Site
      • Swansea, Det Forenede Kongerige, SA6 6NL
        • Novo Nordisk Investigational Site
  • Forenede Stater
    • California
      • Concord, California, Forenede Stater, 94520
        • Novo Nordisk Investigational Site
      • La Jolla, California, Forenede Stater, 92037
        • Novo Nordisk Investigational Site
      • Los Angeles, California, Forenede Stater, 90057
        • Novo Nordisk Investigational Site
      • Monterey, California, Forenede Stater, 93940
        • Novo Nordisk Investigational Site
      • San Diego, California, Forenede Stater, 92111
        • Novo Nordisk Investigational Site
      • San Ramon, California, Forenede Stater, 94583
        • Novo Nordisk Investigational Site
      • Torrance, California, Forenede Stater, 90502
        • Novo Nordisk Investigational Site
      • Tustin, California, Forenede Stater, 92780
        • Novo Nordisk Investigational Site
      • Ventura, California, Forenede Stater, 93003
        • Novo Nordisk Investigational Site
    • Colorado
      • Golden, Colorado, Forenede Stater, 80401
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, Forenede Stater, 33472
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, Forenede Stater, 32216
        • Novo Nordisk Investigational Site
      • Miami, Florida, Forenede Stater, 33156
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, Forenede Stater, 33027
        • Novo Nordisk Investigational Site
      • Plantation, Florida, Forenede Stater, 33324
        • Novo Nordisk Investigational Site
      • Saint Petersburg, Florida, Forenede Stater, 33711
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30303
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, Forenede Stater, 30076
        • Novo Nordisk Investigational Site
    • Indiana
      • Avon, Indiana, Forenede Stater, 46123
        • Novo Nordisk Investigational Site
      • Franklin, Indiana, Forenede Stater, 46131
        • Novo Nordisk Investigational Site
      • Greenfield, Indiana, Forenede Stater, 46140
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, Forenede Stater, 47304
        • Novo Nordisk Investigational Site
    • Louisiana
      • Slidell, Louisiana, Forenede Stater, 70461-4231
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Novo Nordisk Investigational Site
    • Michigan
      • Buckley, Michigan, Forenede Stater, 49620
        • Novo Nordisk Investigational Site
      • Southfield, Michigan, Forenede Stater, 48034-7661
        • Novo Nordisk Investigational Site
    • Montana
      • Great Falls, Montana, Forenede Stater, 59405
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, Forenede Stater, 03063
        • Novo Nordisk Investigational Site
    • New York
      • Rosedale, New York, Forenede Stater, 11422
        • Novo Nordisk Investigational Site
      • Staten Island, New York, Forenede Stater, 10301
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27834
        • Novo Nordisk Investigational Site
      • Mooresville, North Carolina, Forenede Stater, 28117
        • Novo Nordisk Investigational Site
    • Ohio
      • Franklin, Ohio, Forenede Stater, 45005
        • Novo Nordisk Investigational Site
      • Mason, Ohio, Forenede Stater, 45040-6815
        • Novo Nordisk Investigational Site
      • Wadsworth, Ohio, Forenede Stater, 44281-9236
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • McMurray, Pennsylvania, Forenede Stater, 15317
        • Novo Nordisk Investigational Site
      • Norristown, Pennsylvania, Forenede Stater, 19401
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Novo Nordisk Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37411
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, Forenede Stater, 37404-1192
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, Forenede Stater, 79423
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, Forenede Stater, 77479
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23606
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, Forenede Stater, 23294
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, Forenede Stater, 23219
        • Novo Nordisk Investigational Site
      • Richmond, Virginia, Forenede Stater, 23298
        • Novo Nordisk Investigational Site
      • Winchester, Virginia, Forenede Stater, 22601
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Novo Nordisk Investigational Site
  • Frankrig
      • Brest, Frankrig, 29609
        • Novo Nordisk Investigational Site
      • LA ROCHE-sur-YON cedex 9, Frankrig, 85295
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex, Frankrig, 17019
        • Novo Nordisk Investigational Site
      • Pointe À Pitre, Frankrig, 97159
        • Novo Nordisk Investigational Site
      • Strasbourg, Frankrig, 67000
        • Novo Nordisk Investigational Site
  • Polen
      • Bialystok, Polen, 15-435
        • Novo Nordisk Investigational Site
      • Bialystok, Polen, 15-381
        • Novo Nordisk Investigational Site
      • Gdansk, Polen, 80-546
        • Novo Nordisk Investigational Site
      • Katowice, Polen, 40-767
        • Novo Nordisk Investigational Site
      • Krakow, Polen, 31-261
        • Novo Nordisk Investigational Site
      • Poznan, Polen, 60-569
        • Novo Nordisk Investigational Site
      • Poznan, Polen, 60-111
        • Novo Nordisk Investigational Site
      • Zabrze, Polen, 41-800
        • Novo Nordisk Investigational Site
  • Ukraine
      • Kharkiv, Ukraine, 61000
        • Novo Nordisk Investigational Site
      • Kiev, Ukraine, 04053
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 04114
        • Novo Nordisk Investigational Site
      • Vinnytsia, Ukraine, 21010
        • Novo Nordisk Investigational Site
      • Zaporizhia, Ukraine, 69600
        • Novo Nordisk Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Or Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
  • HbA1c 7-10% (both inclusive)
  • Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit
  • Body Mass Index (BMI) 20-45 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
  • Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator
  • Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram))
  • Heart failure defined as New York Heart Association (NYHA) class IV
  • A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure above or equal to 100 mmHg
  • Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
  • Use of immunosuppressive treatment within 90 days prior to screening
  • Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  • Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: placebo
Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.
Eksperimentel: Lire 1,8 mg
Medicin: liraglutide
1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)
Tidsramme: Week 0, Week 26
Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.
Week 0, Week 26

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
Tidsramme: At week 26
Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.
At week 26
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment
Tidsramme: At week 26
Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.
At week 26
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles
Tidsramme: Week 0, week 26
SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.
Week 0, week 26
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)
Tidsramme: Week 0, week 26
Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.
Week 0, week 26
Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)
Tidsramme: Week 0, week 26
Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.
Week 0, week 26

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. juni 2012

Primær færdiggørelse (Faktiske)

20. august 2013

Studieafslutning (Faktiske)

20. august 2013

Datoer for studieregistrering

Først indsendt

13. juni 2012

Først indsendt, der opfyldte QC-kriterier

13. juni 2012

Først opslået (Skøn)

15. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN2211-3916
  • 2011-002968-24 (EudraCT nummer)
  • U1111-1122-3303 (Anden identifikator: WHO)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetes mellitus, type 2

Kliniske forsøg med liraglutide

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Algeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner