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

18 april 2017 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

497

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 77 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Dapagliflozin 1 mg
Dapagliflozin: 1 mg
Läkemedel: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Andra namn:
  • BMS-512148
  • Farxiga™
Experimentell: Dapagliflozin 2.5 mg
Dapagliflozin: 2.5 mg
Läkemedel: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Andra namn:
  • BMS-512148
  • Farxiga™
Experimentell: Dapagliflozin 5 mg
Dapagliflozin: 5 mg
Läkemedel: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Andra namn:
  • BMS-512148
  • Farxiga™
Placebo-jämförare: Placebo
Placebo: 0 mg
Läkemedel: Placebo
Tablets, Oral, Once Daily, Up to 24 weeks

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Samarbetspartners

Bristol-Myers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 september 2008

Primärt slutförande (Faktisk)

29 december 2009

Avslutad studie (Faktisk)

29 december 2009

Studieregistreringsdatum

Först inskickad

15 augusti 2008

Först inskickad som uppfyllde QC-kriterierna

15 augusti 2008

Första postat (Uppskatta)

18 augusti 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 april 2017

Senast verifierad

1 april 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MB102-032

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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