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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 september 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

915

Fas

  • Fas 3

Kontakter och platser

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

Studieorter

  • Argentina
      • Buenos Aires, Argentina, 1431
        • Local Institution
      • Cordoba, Argentina, 5000
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1034
        • Local Institution
      • Capital Federal, Buenos Aires, Argentina, 1429
        • Local Institution
      • Capital Federal, Buenos Aires, Argentina, C1056ABJ
        • Local Institution
      • Capital Federal, Buenos Aires, Argentina, C1425AGC
        • Local Institution
      • Ciudad Auton, Buenos Aires, Argentina, C1408INH
        • Local Institution
      • Ciudad Auton., Buenos Aires, Argentina, C1505CWB
        • Local Institution
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Local Institution
      • Zarate, Buenos Aires, Argentina, 2800
        • Local Institution
    • Cordoba
      • Villa Carlos Paz, Cordoba, Argentina, 5152
        • Local Institution
  • Brasilien
      • Rio De Janeiro, Brasilien, 20211
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brasilien, 60021
        • Local Institution
    • Minas Gerais
      • Itajuba, Minas Gerais, Brasilien, 37502
        • Local Institution
    • Para
      • Belem, Para, Brasilien, 66073
        • Local Institution
    • Rio Grande Do Sul
      • Caxias Do Sul, Rio Grande Do Sul, Brasilien, 95070
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90020090
        • Local Institution
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90035
        • Local Institution
    • Sao Paulo
      • Marilia, Sao Paulo, Brasilien, 17519
        • Local Institution
  • Förenta staterna
    • Arizona
      • Tempe, Arizona, Förenta staterna, 85282
        • Clinical Research Advantage / Desert Clinical Res, Llc
    • California
      • Encino, California, Förenta staterna, 91436
        • Medical Group of Encino
      • Fresno, California, Förenta staterna, 93720
        • Valley Research
      • Los Angeles, California, Förenta staterna, 90023
        • Randall Shue, D.O.
      • Northridge, California, Förenta staterna, 91325
        • Diabetes Medical Center of California
      • San Diego, California, Förenta staterna, 92117
        • Ritchken & First M.D.'S
      • Spring Valley, California, Förenta staterna, 91978
        • Encompass Clinical Research
      • Torrance, California, Förenta staterna, 90505
        • Raikhel, Marina
    • Colorado
      • Colorado Springs, Colorado, Förenta staterna, 80909
        • Express Care Clinical Res
      • Denver, Colorado, Förenta staterna, 80209
        • Denver Internal Medicine
      • Golden, Colorado, Förenta staterna, 80401
        • New West Physicians
    • Florida
      • Altamonte Springs, Florida, Förenta staterna, 32701
        • Central Florida Clinical Trials, Inc.
      • Chipley, Florida, Förenta staterna, 32428
        • Family Care Associates Of Nw Florida
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 56440
        • Health Partners Research Foundation
    • Missouri
      • Chesterfield, Missouri, Förenta staterna, 63017
        • Woodlake Research
    • Nevada
      • Las Vegas, Nevada, Förenta staterna, 89101
        • Nevada Alliance Against Diabetes
    • North Carolina
      • Morehead City, North Carolina, Förenta staterna, 28557
        • Diabetes & Endocrinology Consultants, PC
    • Ohio
      • Newark, Ohio, Förenta staterna, 43055
        • Newark Physician Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73159
        • Integris Family Care S. Penn
    • Pennsylvania
      • Carlisle, Pennsylvania, Förenta staterna, 17013
        • Cumberland Valley Endocrinology Center, Llc
      • Pittsburgh, Pennsylvania, Förenta staterna, 15216
        • Banksville Medical Pc
    • South Carolina
      • Summerville, South Carolina, Förenta staterna, 29485
        • Palmetto Clinical Research
      • Taylors, South Carolina, Förenta staterna, 29687
        • Southeastern Research Assoc
    • Texas
      • Houston, Texas, Förenta staterna, 77081
        • Texas Center For Drug Development, P.A.
      • San Antonio, Texas, Förenta staterna, 78229
        • Diabetes & Glandular Disease Research Associates, Inc.
      • San Antonio, Texas, Förenta staterna, 78229
        • S.A.M. Clinical Research Center
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84102
        • Optimum Clinical Research
    • Washington
      • Spokane, Washington, Förenta staterna, 99216
        • Office Of Dr. Gray
  • 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
  • Mexiko
      • Durango, Mexiko, 64710
        • Local Institution
    • Distrito Federal
      • Df, Distrito Federal, Mexiko, 11800
        • Local Institution
      • Guadalajara, Distrito Federal, Mexiko, 44670
        • Local Institution
      • Zapopan, Distrito Federal, Mexiko, 45150
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexiko, 44650
        • Local Institution
      • Guadalajara, Jalisco, Mexiko, 44670
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexiko, 64710
        • Local Institution
      • Monterrey, Nuevo Leon, Mexiko, 64460
        • Local Institution
      • Monterrrey, Nuevo Leon, Mexiko, 64700
        • Local Institution
    • Tamaulipas
      • Tampico, Tamaulipas, Mexiko, 89109
        • 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

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

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
Placebo-jämförare: Placebo + Metformin
Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Läkemedel: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Läkemedel: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Experimentell: 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
Läkemedel: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Läkemedel: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Andra namn:
  • BMS-512148
Experimentell: Dapagliflozin, 5 mg + Metformin
Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Läkemedel: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Läkemedel: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Andra namn:
  • BMS-512148
Experimentell: Dapagliflozin, 10 mg + Metformin
Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
Läkemedel: Placebo
Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks
Läkemedel: Metformin
Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Läkemedel: Dapagliflozin
Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks
Andra namn:
  • BMS-512148

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Justerad medelförändring från baslinjen i hemoglobin A1C (HbA1c) vid vecka 24 (senaste observationen som överfördes [LOCF])
Tidsram: Från baslinje till vecka 24
HbA1c mättes som procent av hemoglobin av ett centralt laboratorium. Data efter räddningsmedicin exkluderades från denna analys. Baslinje definierades som den sista bedömningen före startdatumet och tiden för den första dosen av den dubbelblinda studiemedicinen. I de fall då tidpunkten för den första dosen eller tidpunkten för bedömningen inte var tillgänglig, definierades baslinjen som den sista bedömningen på eller före datumet för den första dosen av den dubbelblinda studiemedicinen. HbA1c-mätningar erhölls under kvalificerings- och inledningsperioderna och på dag 1 och vecka 4, 8, 12, 16, 20 och 24 i den dubbelblinda perioden.
Från baslinje till vecka 24

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF])
Tidsram: 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])
Tidsram: 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])
Tidsram: 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])
Tidsram: 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])
Tidsram: 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])
Tidsram: 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])
Tidsram: 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])
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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
Tidsram: 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])
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

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

1 september 2007

Primärt slutförande (Faktisk)

1 november 2008

Avslutad studie (Faktisk)

1 maj 2010

Studieregistreringsdatum

Först inskickad

11 september 2007

Först inskickad som uppfyllde QC-kriterierna

11 september 2007

Första postat (Uppskatta)

12 september 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 oktober 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 september 2015

Senast verifierad

1 september 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MB102-014 LT
  • MB102-014 (Annan identifierare: Other Study ID Numbers:)

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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