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

18 aprile 2017 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

497

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

  • 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
  • Federazione Russa
      • Kursk, Federazione Russa, 305035
        • Local Institution
      • Saint-Petersburg, Federazione Russa, 191015
        • Local Institution
      • Saratov, Federazione Russa, 410012
        • Local Institution
      • Smolensk, Federazione Russa, 214018
        • Local Institution
      • St. Petersburg, Federazione Russa, 195112
        • Local Institution
      • St. Petersburg, Federazione Russa, 195257
        • Local Institution
      • St. Petersburg, Federazione Russa, 197341
        • Local Institution
      • St.Petersburg, Federazione Russa, 197022
        • Local Institution
  • India
      • Ahmedabad, India, 380 015
        • Local Institution
      • Bangalore, India, 560 043
        • Local Institution
      • Bangalore, India, 560 052
        • Local Institution
      • Jaipur, India, 302001
        • Local Institution
      • Jaipur, India, 302016
        • Local Institution
  • Messico
      • Durango, Messico, 34000
        • Local Institution
      • Mexico City, Messico, 06700
        • Local Institution
      • Veracruz, Messico, 91910
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Messico, 11800
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Messico, 44670
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Messico, 64060
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Messico, 97070
        • Local Institution
  • Porto Rico
      • Ponce, Porto Rico, 00716
        • Local Institution
      • Ponce, Porto Rico, 00717
        • Local Institution
  • Stati Uniti
    • Arizona
      • Litchfield Park, Arizona, Stati Uniti, 85340
        • Dedicated Clinical Research
      • Phoenix, Arizona, Stati Uniti, 85051
        • 43rd Medical Associates, P.C.
      • Tempe, Arizona, Stati Uniti, 85282
        • Clinical Research Advantage, Inc.
    • California
      • Fresno, California, Stati Uniti, 93720
        • Valley Research
      • Lomita, California, Stati Uniti, 90717
        • Marina Raikhel, Md, Faafp
      • Los Gatos, California, Stati Uniti, 95032
        • Richard S. Cherlin, MD
      • Tustin, California, Stati Uniti, 92780
        • Orange County Research Center
    • Colorado
      • Greeley, Colorado, Stati Uniti, 80634
        • Family Physicians Of Greeley
    • Connecticut
      • New London, Connecticut, Stati Uniti, 06320
        • Coastal Connecticut Research, LLC
    • Florida
      • Altamonte Springs, Florida, Stati Uniti, 32701
        • Central Florida Clinical Trials, Inc.
      • Jacksonville, Florida, Stati Uniti, 32205
        • Westside Center for Clinical Research
      • Marianna, Florida, Stati Uniti, 32446
        • Panhandle Family Care Associates
    • Georgia
      • Roswell, Georgia, Stati Uniti, 30076
        • Endocrine Research Solutions, Inc.
    • Mississippi
      • Belzoni, Mississippi, Stati Uniti, 39038
        • Belzoni Clinical Research
    • New Jersey
      • Hamilton, New Jersey, Stati Uniti, 08690
        • R-Research
    • New York
      • Syracuse, New York, Stati Uniti, 13210
        • Internist Associates Of Central New York
      • West Seneca, New York, Stati Uniti, 14224
        • Southgate Medical Group
    • North Carolina
      • Morehead City, North Carolina, Stati Uniti, 28557
        • Down East Medical Associates, PA
    • Ohio
      • Akron, Ohio, Stati Uniti, 44319
        • James J. Brown, Md
    • Oklahoma
      • Oklahoma, Oklahoma, Stati Uniti, 73170
        • Integris Family Care South
    • South Carolina
      • Taylors, South Carolina, Stati Uniti, 29687
        • Southeastern Research Associates, Inc.
    • Texas
      • San Antonio, Texas, Stati Uniti, 78224
        • Abbott Clinical Research Group, Inc
    • Utah
      • Midvale, Utah, Stati Uniti, 84047
        • Avastra Clinical Trials
      • Salt Lake City, Utah, Stati Uniti, 84102
        • Optimum Clinical Research, Inc.
    • Washington
      • Olympia, Washington, Stati Uniti, 98502
        • Capital Clinical Research Center
      • Spokane, Washington, Stati Uniti, 99216
        • Stephen G. Danley, Do
  • Sud Africa
    • Gauteng
      • Benoni, Gauteng, Sud Africa, 1501
        • Local Institution
      • Soweto, Gauteng, Sud Africa, 1818
        • Local Institution
    • Western Cape
      • Paarl, Western Cape, Sud Africa, 7646
        • Local Institution
      • Tygerberg, Western Cape, Sud Africa, 7505
        • Local Institution

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

Da 18 anni a 77 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

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
Sperimentale: Dapagliflozin 1 mg
Dapagliflozin: 1 mg
Droga: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Altri nomi:
  • BMS-512148
  • Farxiga™
Sperimentale: Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
Droga: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Altri nomi:
  • BMS-512148
  • Farxiga™
Sperimentale: Dapagliflozin 5 mg
Dapagliflozin: 5 mg
Droga: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Altri nomi:
  • BMS-512148
  • Farxiga™
Comparatore placebo: Placebo
Placebo: 0 mg
Droga: Placebo
Tablets, Oral, Once Daily, Up to 24 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

AstraZeneca

Collaboratori

Bristol-Myers Squibb

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

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)

22 settembre 2008

Completamento primario (Effettivo)

29 dicembre 2009

Completamento dello studio (Effettivo)

29 dicembre 2009

Date di iscrizione allo studio

Primo inviato

15 agosto 2008

Primo inviato che soddisfa i criteri di controllo qualità

15 agosto 2008

Primo Inserito (Stima)

18 agosto 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 aprile 2017

Ultimo verificato

1 aprile 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MB102-032

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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 .

Prove cliniche su Dapagliflozin

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Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Uruguay

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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