Information:
Fel:
ID
24009
Beskrivning
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00525330
Länk
https://clinicaltrials.gov/show/NCT00525330
Nyckelord
Versioner (1)
- 2017-07-21 2017-07-21 -
Uppladdad den
21 juli 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00525330
Eligibility Type 2 Diabetes NCT00525330
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes NCT00525330
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
ID.1
Item
1. age 18 to 70 years, inclusive;
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
2. males and females of non-childbearing potential;
boolean
C0032961 (UMLS CUI [1])
ID.3
Item
3. diagnosis of type 2 diabetes mellitus according; and
boolean
C0011860 (UMLS CUI [1])
ID.4
Item
4. on a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
ID.5
Item
1. history of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
boolean
C0011854 (UMLS CUI [1,1])
C0011880 (UMLS CUI [1,2])
C0745151 (UMLS CUI [1,3])
C0011880 (UMLS CUI [1,2])
C0745151 (UMLS CUI [1,3])
ID.6
Item
2. history or presence of alcoholism or drug abuse
boolean
C0085762 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
C0013146 (UMLS CUI [1,2])
ID.7
Item
3. typical consumption of ≥10 drinks of alcohol weekly;
boolean
C0085762 (UMLS CUI [1,1])
C0556332 (UMLS CUI [1,2])
C0556332 (UMLS CUI [1,2])
ID.9
Item
significant renal impairment (glomerular filtration rate <60 ml/min [to be calculated by the central laboratory]);
boolean
C1565489 (UMLS CUI [1])
ID.10
Item
diabetic retinopathy;
boolean
C0011884 (UMLS CUI [1])
ID.11
Item
diabetic gastroparesis;
boolean
C0267176 (UMLS CUI [1])
ID.12
Item
active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
boolean
C0023890 (UMLS CUI [1,1])
C2924508 (UMLS CUI [1,2])
C0016977 (UMLS CUI [1,3])
C2924508 (UMLS CUI [1,2])
C0016977 (UMLS CUI [1,3])
ID.13
Item
5. uncontrolled high blood pressure;
boolean
C0020538 (UMLS CUI [1])
ID.14
Item
6. history or evidence of cardiovascular or pulmonary disease
boolean
C0007222 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
C0024115 (UMLS CUI [1,2])
ID.15
Item
7. must meet other laboratory and medical history clinical criteria. please contact recruitment center for referrals
boolean
C0262926 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])