Information:
Fel:
ID
44874
Beskrivning
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Screening
Nyckelord
Versioner (3)
- 2016-08-10 2016-08-10 -
- 2016-09-28 2016-09-28 -
- 2022-02-18 2022-02-18 - Martin Dugas
Rättsinnehavare
Astellas Pharma Inc
Uppladdad den
18 februari 2022
DOI
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Licens
Creative Commons BY-NC 4.0
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Screening Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
Screening Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
- StudyEvent: ODM
Similar models
Screening Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Protocol Version
Item
Protocol Version
text
C2985700 (UMLS CUI [1])
Informed Consent
Item
Informed Consent
date
C0021430 (UMLS CUI [1])
Eligibility, Inclusion Criteria
Item
Is the subject fully eligible per the Inclusion criteria?
boolean
C1512693 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
C0013893 (UMLS CUI [1,2])
Informed Consent
Item
Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulation (e.g. HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawel of prohibited medication, if applicable).
boolean
C0021430 (UMLS CUI [1])
Age | Gender
Item
Subject is male or female and 18 years and older.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0079399 (UMLS CUI [2])
Type 2 Diabetes Mellitus
Item
Subject has been diagnosed with Type 2 Diabetes Mellitus for at least 6 weeks.
boolean
C0011860 (UMLS CUI [1])
HbA1c
Item
Subject has a HbA1c value between 6.8 and 9.5% at Visit 1 AND has a HbA1c value between 7.0 and 9.5%, inclusive, at Visit 3 AND does not meet any of the fasting plasma glucose (FPG) withdrawel criteria.
boolean
C0019018 (UMLS CUI [1])
Diabetes mellitus Medication
Item
Subject is naive to anti-diabetic medication; OR is receiving a single anti-diabetic agent or low dose of a dual oral combination therapy (< or = 50% of maximum doses of each component), and is willing and able to safely discontinue anti-diabetic therapy at Screening (for at least 8 weeks prior to the first dose of study medication) and for the duration of the study (24 weeks total).
boolean
C0948092 (UMLS CUI [1])
Diet | Exercise
Item
Subject is on a stable diet and exercise program (for at least 6 weeks prior to Screening) and is willing to remain on this program for the duration of the study
boolean
C0012155 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0015259 (UMLS CUI [2])
BMI
Item
Subject has a body mass index (BMI) 20 - 45 kg/m" at Visit 1.
boolean
C1305855 (UMLS CUI [1])
Pregnancy
Item
Female subject of childbearing potential has a negative pregnancy test at Visit 1 and 4 and agrees to use an acceptable form of contraception throughout the duration of the study OR is at least 2 years postmenopausal or surgically sterile.
boolean
C0032961 (UMLS CUI [1])
Eligibility, Exclusion
Item
Is the subject fully eligible per the Exclusion criteria?
boolean
C0680251 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
C0013893 (UMLS CUI [1,2])
Complication
Item
Subject has any known complication of T2DM indication a late disease state that in the Investigator's opinion should preclude the subject from participation.
boolean
C0009566 (UMLS CUI [1])
Type 1 Diabetes mellitus
Item
Subject has type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
insulin
Item
Subject is in need of insulin therapy or has received insulin within 3 months prior to Visit 1, with the exception of acute use of <7 days.
boolean
C0021641 (UMLS CUI [1])
creatinine
Item
Subjact has a serum creatinine higher than upper limit of normal at Visit 1 or 3.
boolean
C0201976 (UMLS CUI [1])
ALT | AST | Bilirubin
Item
Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal at Visit 1 or 3.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201899 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
microalbumin, creatinine
Item
Subject has a urinary microalbumin/urinary creatinine ratio >300mg/g at Visit 1 or 3.
boolean
C2362049 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201976 (UMLS CUI [2])
urinary tract infection | genital infection
Item
Subject has a symptomatic urinary tract infection or genital infection at any time during the Screening or Placebo Run-In Period, including just prior to randomization at Visit 4.
boolean
C0042029 (UMLS CUI [1])
C0729552 (UMLS CUI [2])
C0729552 (UMLS CUI [2])
hypertension
Item
Subject has persistent, uncontrolled severe hypertension as indicated by a systolic blood pressure >180 mmHg or a diastolic blood pressure of >110mmHg taken in a sitting or supine position after 5 minutes of rest on at least 2 measurements (within 30 minutes of each other) at Visits 1, 2 or 3.
text
C0020538 (UMLS CUI [1])
cardiovascular disease
Item
Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) within 3 months prior to Visit 1 or a history of heart failure (NYHA Class III-IV).
boolean
C0007222 (UMLS CUI [1])
Hepatitis | HIV
Item
Subject is known to have hepatitis or be a carrier of hepatitis B surface antigen (HBaAg), hepatitis C virus (HCV) antibody (ELISA plus confirmatory test) or is known positive for HIV1 and/or HIV2.
boolean
C0019158 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
C0019682 (UMLS CUI [2])
medication
Item
Subject is currently receiving an excluded medication (loop diuretics or systemic corticosteroids) or is unwilling to discontinure a restricted medication for the duration of the study.
boolean
C0013227 (UMLS CUI [1])
lactic acidosis
Item
Subject has a history of lactic acidosis.
boolean
C0001125 (UMLS CUI [1])
drug abuse | alcohol abuse
Item
Subject has a history of drug and alcohol abuse/dependency within 12 months prior to Visit 1 as defined in the Diagnostic and Statistical Manual-IV (DSM-IV).
boolean
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
C0085762 (UMLS CUI [2])
malignancy
Item
Subject has had a malignancy in the last 5 years, except for successfully treated basal or squamous cell carcinoma of the skin or carcinoma insitu of the cervix
boolean
C0006826 (UMLS CUI [1])
lactating
Item
Female subject is lactating.
boolean
C2828358 (UMLS CUI [1])
mental ilness
Item
Subject has an unstable medical or psychiatric illness.
boolean
C0004936 (UMLS CUI [1])
hypersensitivity
Item
Subject has known or suspected hypersensitivity to, or components of, ASP1941 or metformin.
boolean
C0020517 (UMLS CUI [1])
ASP1941
Item
Subject has previously received ASP1941.
boolean
Drug study
Item
Subject is concurrently participating in another drug study or has received an investigational drug (including placebo) within 30 days prior to Visit 1.
boolean
illness
Item
Subject has any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety or completion of this study.
boolean
C0221423 (UMLS CUI [1])
Eligibility
Item
In the Investigator's judgment, the subject is unable to adhere to the treatment regimen, protocol procedures or study requirements.
boolean
C0013893 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
Date of birth
Item
Date of birth:
date
C0421451 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
CL Item
White (1)
CL Item
Black (2)
CL Item
Black or African American (3)
CL Item
Asian (4)
CL Item
American Indian or Alaskan Native (5)
CL Item
Native Hawaiian or Other Pacific Islander (6)
CL Item
Mestizo (7)
CL Item
Asian-Indian (8)
CL Item
Filipino (9)
CL Item
Other (99)
Race, Other
Item
If Other, specify:
text
C0034510 (UMLS CUI [1])
CL Item
Not Hispanic or Latino (1)
CL Item
Hispanic or Latino (2)
CL Item
Type II Diabetes Mellitus (1)
Date of Diagnosis
Item
Date of Diagnosis
date
C2316983 (UMLS CUI [1])
Sexually active
Item
Currently sexually active?
boolean
C0241028 (UMLS CUI [1])
Circumcision
Item
Male subject circumcised?
boolean
C0008819 (UMLS CUI [1])
Vascular Disease
Item
Family history of Vascular Disease
boolean
C0241889 (UMLS CUI [1,1])
C1881056 (UMLS CUI [1,2])
C1881056 (UMLS CUI [1,2])
Date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
CL Item
Never used Tobacco (1)
C0425293 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Former Tobacco User (2)
C0337671 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Current Tobacco User (3)
C3241966 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Cigarettes (1)
CL Item
Cigars (2)
CL Item
Pipes (Bowls) (3)
CL Item
Chews (4)
Tobacco quantity
Item
For Former Tobacco User or Current Tobacco User, please specify quantity (/day):
text
C0040329 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
CL Item
Never used Alcohol (1)
C0678274 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Former Alcohol User (2)
C0552479 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Current Alcohol User (3)
C0556297 (UMLS CUI-1)
(Comment:en)
(Comment:en)
Alcohol quantity
Item
For Former Alcohol User or Current Alcohol User, please specify quantity (units/week): 1 Alcohol Unit = 1 can of beer, 1 glass of wine, or 1 shot of hard liquor
text
C0001962 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Item
Diagnosis
integer
C0011900 (UMLS CUI [1])
C0042029 (UMLS CUI [2])
C0042029 (UMLS CUI [2])
CL Item
Urinary Tract Infection (1)
History of Urinary Tract Infection
Item
History of Urinary Tract Infection
boolean
C0019664 (UMLS CUI [1])
C0042029 (UMLS CUI [2])
C0042029 (UMLS CUI [2])
Urinary Tract Infection Occurrence
Item
History of Urinary Tract Infection If yes, how many UTIs did the subject have in the past year?
text
C0042029 (UMLS CUI [1])
C2745955 (UMLS CUI [2])
C2745955 (UMLS CUI [2])
Item
If one or more, please provide the details of the most recent historical infection. Site of Infection:
integer
C0042029 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,2])
Code List
If one or more, please provide the details of the most recent historical infection. Site of Infection:
CL Item
Upper (1)
CL Item
Lower (2)
CL Item
Upper and Lower (3)
CL Item
Unknown (4)
CL Item
Bacterial (1)
CL Item
Viral (2)
CL Item
Fungal (3)
CL Item
Unkown (4)
Item
Organism confirmed by Lab?
integer
C0042029 (UMLS CUI [1,1])
C0029235 (UMLS CUI [1,2])
C0029235 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Onset Date
Item
Onset Date
date
C0042029 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Ongoing
Item
Is Medical Condition ongoing?
boolean
C0042029 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Recovery
Item
Recovery Date
date
C0042029 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
C2004454 (UMLS CUI [1,2])
Item
Was the infection symptomatic?
integer
C0042029 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,2])
CL Item
Symptomatic (1)
CL Item
Asymptomatic (2)
CL Item
Unknown (3)
Item
Was the infection treated?
integer
C0042029 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Genital Infection (1)
History
Item
Does the subject have a history of Genital Infections?
boolean
C0729552 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
Occurence
Item
If yes, how many genital infections did the subject have in the past year?
text
C0729552 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,2])
Item
If one or more, please provide the details of the most recent historical infection. Site of Infection:
integer
C0475264 (UMLS CUI [1,1])
C0729552 (UMLS CUI [1,2])
C0729552 (UMLS CUI [1,2])
Code List
If one or more, please provide the details of the most recent historical infection. Site of Infection:
CL Item
Vaginal (1)
CL Item
Labia (2)
CL Item
Uterus/Fallopian Tubes/Ovaries (3)
CL Item
Urethra (4)
CL Item
Penis (5)
CL Item
Foreskin/Glans (6)
CL Item
Testicles/Epididymis (7)
CL Item
Other (8)
CL Item
Bacterial (Bacterial)
CL Item
Viral (Viral)
CL Item
Fungal (Fungal)
CL Item
Unkown (Unkown)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Onset Date
Item
Onset Date:
date
C0729552 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Medical Condition Ongoing
Item
Is Medical Condition ongoing?
boolean
C0729552 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Recovery
Item
Recovery Date
date
C0729552 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
C2004454 (UMLS CUI [1,2])
Item
Was the infection symptomatic?
integer
C0729552 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Was the infection treated?
integer
C0729552 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Physical Examination
Item
Was the physical examination performed? Record any abnormal findings/conditions identified during the exam on the appropriate form.
boolean
C0031809 (UMLS CUI [1])
Assessment Date
Item
Assessment Date
date
C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Assessment
Item
Not done:
boolean
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
Assessment Date
Item
Assessment Date
date
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Assessment Time
Item
Assessment Time
time
C0518766 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
CL Item
Sitting (1)
CL Item
Standing (2)
Item
Location of blood pressure measurement
integer
C0005823 (UMLS CUI [1])
CL Item
Right Arm (1)
CL Item
Left Arm (2)
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse Rate
integer
C0232117 (UMLS CUI [1])
ECG Date
Item
Date ECG was performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
ECG time
Item
ECG Time performed
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item
ECG Interpretation
integer
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
CL Item
Normal (0 )
C0205307 (UMLS CUI-1)
(Comment:en)
(Comment:en)
CL Item
Abnormal - not clinically significant (1 )
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
(Comment:en)
C2985739 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
(Comment:en)
CL Item
Abnormal - clinically significant (2 )
C0205161 (UMLS CUI-1)
C2985739 (UMLS CUI-2)
(Comment:en)
C2985739 (UMLS CUI-2)
(Comment:en)
Assessment Date
Item
Date of Measurements
date
C2985720 (UMLS CUI [1])
Height
Item
Body height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
BMI
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Any Previous anti-diabetes medication
Item
Did the subject take any Previous anti-diabetes medication and requires a 6 week washout?
boolean
C2054148 (UMLS CUI [1])
Potential childbearing
Item
Is subject female and of childbearing potential?
boolean
C3831118 (UMLS CUI [1])
Item
If no childbearing potential, please provide reason why a pregnancy test not done:
integer
C0032976 (UMLS CUI [1])
Code List
If no childbearing potential, please provide reason why a pregnancy test not done:
CL Item
Female (2yrs post menopausal or surgically sterile) (1)
CL Item
Pre-Puberty (2)
CL Item
Male (3)
CL Item
Other (4)
CL Item
Not Done (1)
Pregnancy Test: Date
Item
Date of Sample Taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
negative (0)
CL Item
positive (1)