Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

18. april 2017 opdateret af: AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

497

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3C 3P1
        • Local Institution
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3V9
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Local Institution
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
        • Local Institution
    • Ontario
      • Ajax, Ontario, Canada, L1S 7J5
        • Local Institution
      • Toronto, Ontario, Canada, M9W 4L6
        • Local Institution
      • Waterloo, Ontario, Canada, N2T 2Z6
        • Local Institution
    • Quebec
      • Drummondville, Quebec, Canada, J2B 7T1
        • Local Institution
      • L'Ancienne Lorette, Quebec, Canada, G2E 2X1
        • Local Institution
      • St-Leonard, Quebec, Canada, H1S 3A9
        • Local Institution
  • Den Russiske Føderation
      • Kursk, Den Russiske Føderation, 305035
        • Local Institution
      • Saint-Petersburg, Den Russiske Føderation, 191015
        • Local Institution
      • Saratov, Den Russiske Føderation, 410012
        • Local Institution
      • Smolensk, Den Russiske Føderation, 214018
        • Local Institution
      • St. Petersburg, Den Russiske Føderation, 195112
        • Local Institution
      • St. Petersburg, Den Russiske Føderation, 195257
        • Local Institution
      • St. Petersburg, Den Russiske Føderation, 197341
        • Local Institution
      • St.Petersburg, Den Russiske Føderation, 197022
        • Local Institution
  • Forenede Stater
    • Arizona
      • Litchfield Park, Arizona, Forenede Stater, 85340
        • Dedicated Clinical Research
      • Phoenix, Arizona, Forenede Stater, 85051
        • 43rd Medical Associates, P.C.
      • Tempe, Arizona, Forenede Stater, 85282
        • Clinical Research Advantage, Inc.
    • California
      • Fresno, California, Forenede Stater, 93720
        • Valley Research
      • Lomita, California, Forenede Stater, 90717
        • Marina Raikhel, Md, Faafp
      • Los Gatos, California, Forenede Stater, 95032
        • Richard S. Cherlin, MD
      • Tustin, California, Forenede Stater, 92780
        • Orange County Research Center
    • Colorado
      • Greeley, Colorado, Forenede Stater, 80634
        • Family Physicians Of Greeley
    • Connecticut
      • New London, Connecticut, Forenede Stater, 06320
        • Coastal Connecticut Research, LLC
    • Florida
      • Altamonte Springs, Florida, Forenede Stater, 32701
        • Central Florida Clinical Trials, Inc.
      • Jacksonville, Florida, Forenede Stater, 32205
        • Westside Center for Clinical Research
      • Marianna, Florida, Forenede Stater, 32446
        • Panhandle Family Care Associates
    • Georgia
      • Roswell, Georgia, Forenede Stater, 30076
        • Endocrine Research Solutions, Inc.
    • Mississippi
      • Belzoni, Mississippi, Forenede Stater, 39038
        • Belzoni Clinical Research
    • New Jersey
      • Hamilton, New Jersey, Forenede Stater, 08690
        • R-Research
    • New York
      • Syracuse, New York, Forenede Stater, 13210
        • Internist Associates Of Central New York
      • West Seneca, New York, Forenede Stater, 14224
        • Southgate Medical Group
    • North Carolina
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Down East Medical Associates, PA
    • Ohio
      • Akron, Ohio, Forenede Stater, 44319
        • James J. Brown, Md
    • Oklahoma
      • Oklahoma, Oklahoma, Forenede Stater, 73170
        • Integris Family Care South
    • South Carolina
      • Taylors, South Carolina, Forenede Stater, 29687
        • Southeastern Research Associates, Inc.
    • Texas
      • San Antonio, Texas, Forenede Stater, 78224
        • Abbott Clinical Research Group, Inc
    • Utah
      • Midvale, Utah, Forenede Stater, 84047
        • Avastra Clinical Trials
      • Salt Lake City, Utah, Forenede Stater, 84102
        • Optimum Clinical Research, Inc.
    • Washington
      • Olympia, Washington, Forenede Stater, 98502
        • Capital Clinical Research Center
      • Spokane, Washington, Forenede Stater, 99216
        • Stephen G. Danley, Do
  • Indien
      • Ahmedabad, Indien, 380 015
        • Local Institution
      • Bangalore, Indien, 560 043
        • Local Institution
      • Bangalore, Indien, 560 052
        • Local Institution
      • Jaipur, Indien, 302001
        • Local Institution
      • Jaipur, Indien, 302016
        • Local Institution
  • Mexico
      • Durango, Mexico, 34000
        • Local Institution
      • Mexico City, Mexico, 06700
        • Local Institution
      • Veracruz, Mexico, 91910
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Mexico, 11800
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64060
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Local Institution
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Local Institution
      • Ponce, Puerto Rico, 00717
        • Local Institution
  • Sydafrika
    • Gauteng
      • Benoni, Gauteng, Sydafrika, 1501
        • Local Institution
      • Soweto, Gauteng, Sydafrika, 1818
        • Local Institution
    • Western Cape
      • Paarl, Western Cape, Sydafrika, 7646
        • Local Institution
      • Tygerberg, Western Cape, Sydafrika, 7505
        • Local Institution

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 77 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
  • Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
  • C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
  • Body Mass Index ≤ 45 kg/m²
  • Must be able to perform self monitoring of blood glucose

Exclusion Criteria:

  • aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)
  • Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
  • Creatinine kinase >3* ULN
  • Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

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
Eksperimentel: Dapagliflozin 1 mg
Dapagliflozin: 1 mg
Medicin: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Andre navne:
  • BMS-512148
  • Farxiga™
Eksperimentel: Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
Medicin: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Andre navne:
  • BMS-512148
  • Farxiga™
Eksperimentel: Dapagliflozin 5 mg
Dapagliflozin: 5 mg
Medicin: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Andre navne:
  • BMS-512148
  • Farxiga™
Placebo komparator: Placebo
Placebo: 0 mg
Medicin: Placebo
Tablets, Oral, Once Daily, Up to 24 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
Tidsramme: Baseline (Day 1), Week 24
Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.
Baseline (Day 1), Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
Tidsramme: Baseline (Day 1), Week 24
Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.
Baseline (Day 1), Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants
Tidsramme: Baseline (Day 1), Week 24
Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Baseline (Day 1), Week 24
Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants
Tidsramme: Baseline (Day 1), Week 24
Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control. At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication.
Baseline (Day 1), Week 24
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants
Tidsramme: Baseline (Day 1), Week 24
Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
Baseline (Day 1), Week 24
Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants
Tidsramme: Baseline (Day 1), Week 24
Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Baseline (Day 1), Week 24
Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
Tidsramme: Day 1 of Double Blind Period to end of Week 24 Plus 30 days
Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included.
Day 1 of Double Blind Period to end of Week 24 Plus 30 days
Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
Tidsramme: Baseline to last dose plus 4 days in 12 Week Double Blind Period
Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.
Baseline to last dose plus 4 days in 12 Week Double Blind Period
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants
Tidsramme: Baseline (Day 1), Week 24
Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Baseline (Day 1), Week 24
Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants
Tidsramme: Baseline (Day 1), Week 24
Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Baseline (Day 1), Week 24
Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
Tidsramme: Week 24
12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter.
Week 24
Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
Tidsramme: Baseline to Week 24/end of treatment plus 4 days
Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX, >=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN.
Baseline to Week 24/end of treatment plus 4 days

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Samarbejdspartnere

Bristol-Myers Squibb

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

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)

22. september 2008

Primær færdiggørelse (Faktiske)

29. december 2009

Studieafslutning (Faktiske)

29. december 2009

Datoer for studieregistrering

Først indsendt

15. august 2008

Først indsendt, der opfyldte QC-kriterier

15. august 2008

Først opslået (Skøn)

18. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MB102-032

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 Type 2 diabetes mellitus

Kliniske forsøg med Dapagliflozin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner