Information:
Fel:
ID
22957
Beskrivning
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE); ODM derived from: https://clinicaltrials.gov/show/NCT00510952
Länk
https://clinicaltrials.gov/show/NCT00510952
Nyckelord
Versioner (1)
- 2017-06-18 2017-06-18 -
Uppladdad den
18 juni 2017
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00510952
Eligibility Diabetes Mellitus, Type 2 NCT00510952
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT00510952
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
ID.1
Item
have type 2 diabetes mellitus for at least 1 year.
boolean
C0011860 (UMLS CUI [1])
ID.2
Item
are greater than or equal to 18 years old.
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
have been receiving oral antihyperglycemic medications (oams), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following oams for the 6 weeks prior to visit 1: metformin-
boolean
C0087111 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C0025598 (UMLS CUI [1,2])
ID.4
Item
sulfonylureas-dipeptidyl peptidase-iv (dpp-iv) inhibitors-thiazolidinediones (tzds)
boolean
C0087111 (UMLS CUI [1,1])
C3653359 (UMLS CUI [1,2])
C1257987 (UMLS CUI [1,3])
C3653359 (UMLS CUI [1,2])
C1257987 (UMLS CUI [1,3])
ID.5
Item
have a hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before visit 2.
boolean
C0019018 (UMLS CUI [1])
ID.6
Item
body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kg/meter squared.
boolean
C1305855 (UMLS CUI [1])
ID.7
Item
have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
boolean
C0557978 (UMLS CUI [1])
ID.8
Item
have taken any glucose-lowering medications not included in inclusion criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before visit 1.
boolean
C0087111 (UMLS CUI [1])
ID.9
Item
have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
boolean
C0150254 (UMLS CUI [1])
ID.10
Item
have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
boolean
C0726398 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C2114437 (UMLS CUI [1,3])
C0019993 (UMLS CUI [1,2])
C2114437 (UMLS CUI [1,3])
ID.11
Item
are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
boolean
C0032961 (UMLS CUI [1,1])
C0009862 (UMLS CUI [1,2])
C0009862 (UMLS CUI [1,2])