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A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

keskiviikko 30. syyskuuta 2015 päivittänyt: AstraZeneca

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

915

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Argentiina
      • Buenos Aires, Argentiina, 1431
        • Local Institution
      • Cordoba, Argentiina, 5000
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentiina, 1034
        • Local Institution
      • Capital Federal, Buenos Aires, Argentiina, 1429
        • Local Institution
      • Capital Federal, Buenos Aires, Argentiina, C1056ABJ
        • Local Institution
      • Capital Federal, Buenos Aires, Argentiina, C1425AGC
        • Local Institution
      • Ciudad Auton, Buenos Aires, Argentiina, C1408INH
        • Local Institution
      • Ciudad Auton., Buenos Aires, Argentiina, C1505CWB
        • Local Institution
      • Mar Del Plata, Buenos Aires, Argentiina, 7600
        • Local Institution
      • Zarate, Buenos Aires, Argentiina, 2800
        • Local Institution
    • Cordoba
      • Villa Carlos Paz, Cordoba, Argentiina, 5152
        • Local Institution
  • Brasilia
      • Rio De Janeiro, Brasilia, 20211
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brasilia, 60021
        • Local Institution
    • Minas Gerais
      • Itajuba, Minas Gerais, Brasilia, 37502
        • Local Institution
    • Para
      • Belem, Para, Brasilia, 66073
        • Local Institution
    • Rio Grande Do Sul
      • Caxias Do Sul, Rio Grande Do Sul, Brasilia, 95070
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brasilia, 90020090
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brasilia, 90035
        • Local Institution
    • Sao Paulo
      • Marilia, Sao Paulo, Brasilia, 17519
        • Local Institution
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2R 0X7
        • Local Institution
    • British Columbia
      • Kelowna, British Columbia, Kanada, V1Y 2H4
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3E 3P4
        • Local Institution
    • New Brunswick
      • Bathurst, New Brunswick, Kanada, E2A 4X7
        • Local Institution
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Kanada, A1N 1W7
        • Local Institution
      • St-John, Newfoundland and Labrador, Kanada, A1E 2E2
        • Local Institution
    • Ontario
      • Sarnia, Ontario, Kanada, N7T 4X3
        • Local Institution
      • Thornhill, Ontario, Kanada, L4J 8L7
        • Local Institution
      • Toronto, Ontario, Kanada, M4R 2G4
        • Local Institution
      • Toronto, Ontario, Kanada, M9W 4L6
        • Local Institution
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Kanada, C1A 5Y9
        • Local Institution
    • Quebec
      • Drummondville, Quebec, Kanada, J2B 7T1
        • Local Institution
      • Granby, Quebec, Kanada, J2G 8Z9
        • Local Institution
      • L'Ancienne Lorette, Quebec, Kanada, G2E 2X1
        • Local Institution
      • Mirabel, Quebec, Kanada, J7J 2K8
        • Local Institution
      • St-Leonard, Quebec, Kanada, H1S 3A9
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7K 3H3
        • Local Institution
      • Saskatoon, Saskatchewan, Kanada, S7K 7H9
        • Local Institution
  • Meksiko
      • Durango, Meksiko, 64710
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Meksiko, 11800
        • Local Institution
      • Guadalajara, Distrito Federal, Meksiko, 44670
        • Local Institution
      • Zapopan, Distrito Federal, Meksiko, 45150
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Meksiko, 44650
        • Local Institution
      • Guadalajara, Jalisco, Meksiko, 44670
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Meksiko, 64710
        • Local Institution
      • Monterrey, Nuevo Leon, Meksiko, 64460
        • Local Institution
      • Monterrrey, Nuevo Leon, Meksiko, 64700
        • Local Institution
    • Tamaulipas
      • Tampico, Tamaulipas, Meksiko, 89109
        • Local Institution
  • Yhdysvallat
    • Arizona
      • Tempe, Arizona, Yhdysvallat, 85282
        • Clinical Research Advantage / Desert Clinical Res, Llc
    • California
      • Encino, California, Yhdysvallat, 91436
        • Medical Group of Encino
      • Fresno, California, Yhdysvallat, 93720
        • Valley Research
      • Los Angeles, California, Yhdysvallat, 90023
        • Randall Shue, D.O.
      • Northridge, California, Yhdysvallat, 91325
        • Diabetes Medical Center Of California
      • San Diego, California, Yhdysvallat, 92117
        • Ritchken & First M.D.'S
      • Spring Valley, California, Yhdysvallat, 91978
        • Encompass Clinical Research
      • Torrance, California, Yhdysvallat, 90505
        • Raikhel, Marina
    • Colorado
      • Colorado Springs, Colorado, Yhdysvallat, 80909
        • Express Care Clinical Res
      • Denver, Colorado, Yhdysvallat, 80209
        • Denver Internal Medicine
      • Golden, Colorado, Yhdysvallat, 80401
        • New West Physicians
    • Florida
      • Altamonte Springs, Florida, Yhdysvallat, 32701
        • Central Florida Clinical Trials, Inc.
      • Chipley, Florida, Yhdysvallat, 32428
        • Family Care Associates Of Nw Florida
    • Minnesota
      • Minneapolis, Minnesota, Yhdysvallat, 56440
        • Health Partners Research Foundation
    • Missouri
      • Chesterfield, Missouri, Yhdysvallat, 63017
        • Woodlake Research
    • Nevada
      • Las Vegas, Nevada, Yhdysvallat, 89101
        • Nevada Alliance Against Diabetes
    • North Carolina
      • Morehead City, North Carolina, Yhdysvallat, 28557
        • Diabetes & Endocrinology Consultants, PC
    • Ohio
      • Newark, Ohio, Yhdysvallat, 43055
        • Newark Physician Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, Yhdysvallat, 73159
        • Integris Family Care S. Penn
    • Pennsylvania
      • Carlisle, Pennsylvania, Yhdysvallat, 17013
        • Cumberland Valley Endocrinology Center, Llc
      • Pittsburgh, Pennsylvania, Yhdysvallat, 15216
        • Banksville Medical Pc
    • South Carolina
      • Summerville, South Carolina, Yhdysvallat, 29485
        • Palmetto Clinical Research
      • Taylors, South Carolina, Yhdysvallat, 29687
        • Southeastern Research Assoc
    • Texas
      • Houston, Texas, Yhdysvallat, 77081
        • Texas Center For Drug Development, P.A.
      • San Antonio, Texas, Yhdysvallat, 78229
        • Diabetes & Glandular Disease Research Associates, Inc.
      • San Antonio, Texas, Yhdysvallat, 78229
        • S.A.M. Clinical Research Center
    • Utah
      • Salt Lake City, Utah, Yhdysvallat, 84102
        • Optimum Clinical Research
    • Washington
      • Spokane, Washington, Yhdysvallat, 99216
        • Office Of Dr. Gray

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 77 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Key Inclusion Criteria

  • Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
  • Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
  • C-peptide ≥1.0 ng/mL
  • Body mass index ≤45.0 kg/m^2
  • Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

Key Exclusion Criteria

  • Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper limit of normal
  • Serum total bilirubin level >2 mg/dL
  • Creatinine kinase level >3 times upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
  • Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Placebo Comparator: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Lääke: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Lääke: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Kokeellinen: Dapagliflozin, 2.5 mg + Metformin
Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Lääke: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Lääke: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Muut nimet:
  • BMS-512148
Kokeellinen: Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Lääke: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Lääke: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Muut nimet:
  • BMS-512148
Kokeellinen: Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Lääke: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Lääke: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Lääke: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Muut nimet:
  • BMS-512148

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Hemoglobiini A1C:n (HbA1c) mukautettu keskimääräinen muutos lähtötilanteesta viikolla 24 (viimeinen havainto siirretty eteenpäin [LOCF])
Aikaikkuna: Perustasosta viikkoon 24
Keskuslaboratorio mittasi HbA1c:n prosentteina hemoglobiinista. Pelastuslääkityksen jälkeiset tiedot jätettiin pois tästä analyysistä. Lähtötilanne määriteltiin viimeiseksi arvioinniksi ennen kaksoissokkotutkimuksen lääkkeen ensimmäisen annoksen aloituspäivää ja -aikaa. Tapauksissa, joissa ensimmäisen annoksen tai arvioinnin ajankohta ei ollut saatavilla, lähtötaso määriteltiin viimeiseksi arvioitavaksi kaksoissokkotutkimuksen lääkkeen ensimmäisen annoksen päivämääränä tai sitä ennen. HbA1c-mittaukset saatiin pätevöitymis- ja aloitusjaksojen aikana sekä kaksoissokkojakson päivänä 1 ja viikoilla 4, 8, 12, 16, 20 ja 24.
Perustasosta viikkoon 24

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Aikaikkuna: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as 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 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.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF])
Aikaikkuna: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication 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 measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Aikaikkuna: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF])
Aikaikkuna: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c > 9.0%. Data after rescue medication were 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.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])
Aikaikkuna: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication 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 measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])
Aikaikkuna: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were 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.
From Baseline to Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF])
Aikaikkuna: From Baseline to Week 1
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. 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.
From Baseline to Week 1
Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF])
Aikaikkuna: From Baseline to Week 24
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.
From Baseline to Week 24

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation
Aikaikkuna: From Baseline to end of Long-term Period (Week 102)
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. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included.
From Baseline to end of Long-term Period (Week 102)
Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality
Aikaikkuna: Day 1 to Week 102
BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value.
Day 1 to Week 102
Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF])
Aikaikkuna: Baseline to Week 102
12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available.
Baseline to Week 102
Mean Changes From Baseline in Seated Systolic Blood Pressure
Aikaikkuna: From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. 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.
From Baseline to Week 102
Mean Changes From Baseline in Seated Diastolic Blood Pressure
Aikaikkuna: From Baseline to Week 102
Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. 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.
From Baseline to Week 102
Number of Participants With Orthostatic Hypotension
Aikaikkuna: From Baseline to Week 102
Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of >20 mm Hg in systolic blood pressure or >10 mm Hg in diastolic blood pressure.
From Baseline to Week 102

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

AstraZeneca

Yhteistyökumppanit

Bristol-Myers Squibb

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Lauantai 1. syyskuuta 2007

Ensisijainen valmistuminen (Todellinen)

Lauantai 1. marraskuuta 2008

Opintojen valmistuminen (Todellinen)

Lauantai 1. toukokuuta 2010

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Tiistai 11. syyskuuta 2007

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 11. syyskuuta 2007

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 12. syyskuuta 2007

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Tiistai 20. lokakuuta 2015

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 30. syyskuuta 2015

Viimeksi vahvistettu

Tiistai 1. syyskuuta 2015

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • MB102-014 LT
  • MB102-014 (Muu tunniste: Other Study ID Numbers:)

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Tyypin 2 diabetes

Kliiniset tutkimukset Placebo

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Hong Kong

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

Tilaa