Information:
Fel:
ID
29103
Beskrivning
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide; ODM derived from: https://clinicaltrials.gov/show/NCT00560417
Länk
https://clinicaltrials.gov/show/NCT00560417
Nyckelord
Versioner (1)
- 2018-02-24 2018-02-24 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
24 februari 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00560417
Eligibility Diabetes Mellitus, Type 2 NCT00560417
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT00560417
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Diabetes Mellitus, Non-Insulin-Dependent
Item
must have type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
must be at least 18 years of age and less than 75 years of age
boolean
C0001779 (UMLS CUI [1])
Exenatide Frequency U/day
Item
must be taking exenatide 10 micrograms twice a day (bid) for at least 3 months
boolean
C0167117 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0439603 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Antidiabetics Oral | Metformin U/day | Sulfonylurea U/day | Thiazolidinediones U/day | Pioglitazone
Item
must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (tzd). doses must be at or above the following: metformin--1500 mg/day, sulfonylurea--1/2 the maximum daily dose according to the product label, tzd--30 mg/day pioglitazone
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0038766 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C1257987 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0071097 (UMLS CUI [5])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0038766 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C1257987 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0071097 (UMLS CUI [5])
Glucohemoglobin measurement
Item
must have a hemoglobin a1c greater than or equal to 7.0% and less than or equal to 10.0%
boolean
C0202054 (UMLS CUI [1])
Insulin Regular
Item
must not have used insulin on a regular basis during the past 2 years
boolean
C0021641 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,2])
Hypoglycemic Agents | Exception Inclusion criteria Pharmaceutical Preparations
Item
must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Hypoglycemia Severe | Episode Quantity
Item
must not have had more than one episode of severe hypoglycemia in the past 6 months
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Hematological Disease | Disease Oncologic | Kidney Disease | Heart Disease | Liver disease | Gastrointestinal Disease
Item
must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
boolean
C0018939 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205478 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0012634 (UMLS CUI [2,1])
C0205478 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
Pregnancy | Pregnancy, Planned
Item
must not be pregnant or intend to get pregnant during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0032992 (UMLS CUI [2])