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Informations:
Erreur:
ID
18866
Description
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.
Mots-clés
Versions (2)
- 23/11/2016 23/11/2016 -
- 28/01/2017 28/01/2017 -
Téléchargé le
23 novembre 2016
DOI
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Licence
Creative Commons BY-NC-ND 3.0
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Visit 1 Run - Inclusion Criteria NCT01117584
Visit 1 Run - Inclusion Criteria NCT01117584
- StudyEvent: ODM
Similar models
Visit 1 Run - Inclusion Criteria NCT01117584
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
CL Item
INCLUSION (1 )
CL Item
EXCLUSION (2 )
Eligibility
Item
Is the subject fully eligble per the Inclusion Criteria?
boolean
CL Item
Subject has signed informed consent prior to screening (1)
CL Item
Subject is male or female of 18 years of age at Visit 1 (2)
CL Item
Subject has been diagnosed with T2DM for at least 6 month (3)
CL Item
Subject has indequate glycemic control indicated by an HbA1clevel between 7.0% and 9.5% at start of the placebo run-in period at Visit 1 AND does not meet any of the FPG discontinuation criteria (see section 3.4) (4)
CL Item
Subject has been on a stable dose of at least 1500 mg/day metformin monotherapy for at least 6 weeks prior to Visit 1. (5)
CL Item
Subject is on a stable diet and exercise program (for at least 6 weeks prior to Visit 1) and is willing to remain on this program for the duration of the study. (6)
CL Item
Subject has a body mass index (BMI) 20-45 kg/m2 at Visit 1 (7)
CL Item
Female subject of childbearing potential has a negativ serum pregnancy test (human chorionic gonadotropin [hCG] at Visit 1 and agrees to use an acceptable form of contraception throughout the duration of the study OR is at least 1 year post-menopausal (defined as amenorrhea for at least 1 year) or surgically sterile. Acceptable methods of contraception are: oral or injectable hormonal contraceptives, contraceptive patch, intra-uterine devices, vaginal hormonal rings, or sterilization by surgery and only in combination with a male condom, a vaginal diaphragm or cervical caps. Male study subjects should be advised to use a male condom in addition to having their partner use another acceptable method during the study and for 3 month after the last dose. (8)