Information:
Error:
ID
19777
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.
Keywords
Versions (2)
- 11/23/16 11/23/16 -
- 1/28/17 1/28/17 -
Uploaded on
January 28, 2017
DOI
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License
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)
Data type
Alias
CL Item
INCLUSION (1 )
CL Item
EXCLUSION (2 )
Eligibility
Item
Is the subject fully eligble per the Inclusion Criteria?
boolean
C0013893 (UMLS CUI [1])
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)