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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

30 września 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

915

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
      • Buenos Aires, Argentyna, 1431
        • Local Institution
      • Cordoba, Argentyna, 5000
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentyna, 1034
        • Local Institution
      • Capital Federal, Buenos Aires, Argentyna, 1429
        • Local Institution
      • Capital Federal, Buenos Aires, Argentyna, C1056ABJ
        • Local Institution
      • Capital Federal, Buenos Aires, Argentyna, C1425AGC
        • Local Institution
      • Ciudad Auton, Buenos Aires, Argentyna, C1408INH
        • Local Institution
      • Ciudad Auton., Buenos Aires, Argentyna, C1505CWB
        • Local Institution
      • Mar Del Plata, Buenos Aires, Argentyna, 7600
        • Local Institution
      • Zarate, Buenos Aires, Argentyna, 2800
        • Local Institution
    • Cordoba
      • Villa Carlos Paz, Cordoba, Argentyna, 5152
        • Local Institution
  • Brazylia
      • Rio De Janeiro, Brazylia, 20211
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brazylia, 60021
        • Local Institution
    • Minas Gerais
      • Itajuba, Minas Gerais, Brazylia, 37502
        • Local Institution
    • Para
      • Belem, Para, Brazylia, 66073
        • Local Institution
    • Rio Grande Do Sul
      • Caxias Do Sul, Rio Grande Do Sul, Brazylia, 95070
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazylia, 90020090
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brazylia, 90035
        • Local Institution
    • Sao Paulo
      • Marilia, Sao Paulo, Brazylia, 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
  • Meksyk
      • Durango, Meksyk, 64710
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Meksyk, 11800
        • Local Institution
      • Guadalajara, Distrito Federal, Meksyk, 44670
        • Local Institution
      • Zapopan, Distrito Federal, Meksyk, 45150
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Meksyk, 44650
        • Local Institution
      • Guadalajara, Jalisco, Meksyk, 44670
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Meksyk, 64710
        • Local Institution
      • Monterrey, Nuevo Leon, Meksyk, 64460
        • Local Institution
      • Monterrrey, Nuevo Leon, Meksyk, 64700
        • Local Institution
    • Tamaulipas
      • Tampico, Tamaulipas, Meksyk, 89109
        • Local Institution
  • Stany Zjednoczone
    • Arizona
      • Tempe, Arizona, Stany Zjednoczone, 85282
        • Clinical Research Advantage / Desert Clinical Res, Llc
    • California
      • Encino, California, Stany Zjednoczone, 91436
        • Medical Group of Encino
      • Fresno, California, Stany Zjednoczone, 93720
        • Valley Research
      • Los Angeles, California, Stany Zjednoczone, 90023
        • Randall Shue, D.O.
      • Northridge, California, Stany Zjednoczone, 91325
        • Diabetes Medical Center Of California
      • San Diego, California, Stany Zjednoczone, 92117
        • Ritchken & First M.D.'S
      • Spring Valley, California, Stany Zjednoczone, 91978
        • Encompass Clinical Research
      • Torrance, California, Stany Zjednoczone, 90505
        • Raikhel, Marina
    • Colorado
      • Colorado Springs, Colorado, Stany Zjednoczone, 80909
        • Express Care Clinical Res
      • Denver, Colorado, Stany Zjednoczone, 80209
        • Denver Internal Medicine
      • Golden, Colorado, Stany Zjednoczone, 80401
        • New West Physicians
    • Florida
      • Altamonte Springs, Florida, Stany Zjednoczone, 32701
        • Central Florida Clinical Trials, Inc.
      • Chipley, Florida, Stany Zjednoczone, 32428
        • Family Care Associates Of Nw Florida
    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone, 56440
        • Health Partners Research Foundation
    • Missouri
      • Chesterfield, Missouri, Stany Zjednoczone, 63017
        • Woodlake Research
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89101
        • Nevada Alliance Against Diabetes
    • North Carolina
      • Morehead City, North Carolina, Stany Zjednoczone, 28557
        • Diabetes & Endocrinology Consultants, PC
    • Ohio
      • Newark, Ohio, Stany Zjednoczone, 43055
        • Newark Physician Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73159
        • Integris Family Care S. Penn
    • Pennsylvania
      • Carlisle, Pennsylvania, Stany Zjednoczone, 17013
        • Cumberland Valley Endocrinology Center, Llc
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15216
        • Banksville Medical Pc
    • South Carolina
      • Summerville, South Carolina, Stany Zjednoczone, 29485
        • Palmetto Clinical Research
      • Taylors, South Carolina, Stany Zjednoczone, 29687
        • Southeastern Research Assoc
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77081
        • Texas Center For Drug Development, P.A.
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • Diabetes & Glandular Disease Research Associates, Inc.
      • San Antonio, Texas, Stany Zjednoczone, 78229
        • S.A.M. Clinical Research Center
    • Utah
      • Salt Lake City, Utah, Stany Zjednoczone, 84102
        • Optimum Clinical Research
    • Washington
      • Spokane, Washington, Stany Zjednoczone, 99216
        • Office Of Dr. Gray

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 77 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Lek: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Lek: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Eksperymentalny: 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
Lek: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Lek: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Inne nazwy:
  • BMS-512148
Eksperymentalny: Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Lek: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Lek: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Inne nazwy:
  • BMS-512148
Eksperymentalny: Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Lek: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Lek: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Lek: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Inne nazwy:
  • BMS-512148

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Skorygowana średnia zmiana od wartości początkowej stężenia hemoglobiny A1C (HbA1c) w 24. tygodniu (ostatnia obserwacja przeniesiona do przodu [LOCF])
Ramy czasowe: Od punktu początkowego do tygodnia 24
HbA1c mierzono jako procent hemoglobiny przez centralne laboratorium. Dane po podaniu leku doraźnego zostały wyłączone z tej analizy. Linię wyjściową zdefiniowano jako ostatnią ocenę przed datą i godziną rozpoczęcia pierwszej dawki leku badanego metodą podwójnie ślepej próby. W przypadkach, w których czas pierwszej dawki lub czas oceny nie był dostępny, linię bazową zdefiniowano jako ostatnią ocenę w dniu lub przed datą pierwszej dawki badanego leku z podwójnie ślepą próbą. Pomiary HbA1c uzyskano podczas okresu kwalifikacyjnego i wstępnego oraz w Dniu 1 i Tygodniach 4, 8, 12, 16, 20 i 24 w okresie podwójnie ślepej próby.
Od punktu początkowego do tygodnia 24

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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])
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AstraZeneca

Współpracownicy

Bristol-Myers Squibb

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2007

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2008

Ukończenie studiów (Rzeczywisty)

1 maja 2010

Daty rejestracji na studia

Pierwszy przesłany

11 września 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 września 2007

Pierwszy wysłany (Oszacować)

12 września 2007

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

20 października 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 września 2015

Ostatnia weryfikacja

1 września 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • MB102-014 LT
  • MB102-014 (Inny identyfikator: Other Study ID Numbers:)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Cukrzyca typu 2

Badania kliniczne na Placebo

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Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Estonia

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

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