ID

29103

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00560417

Trefwoorden

Versies (1)
  1. 24-02-18 24-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 februari 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes Mellitus, Type 2 NCT00560417

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00560417

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
must be at least 18 years of age and less than 75 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
must be taking exenatide 10 micrograms twice a day (bid) for at least 3 months
Beschrijving

Exenatide Frequency U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0167117
UMLS CUI [1,2]
C0439603
UMLS CUI [1,3]
C0456683
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
Beschrijving

Antidiabetics Oral | Metformin U/day | Sulfonylurea U/day | Thiazolidinediones U/day | Pioglitazone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0038766
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C1257987
UMLS CUI [4,2]
C0456683
UMLS CUI [5]
C0071097
must have a hemoglobin a1c greater than or equal to 7.0% and less than or equal to 10.0%
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
must not have used insulin on a regular basis during the past 2 years
Beschrijving

Insulin Regular

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0205272
must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
Beschrijving

Hypoglycemic Agents | Exception Inclusion criteria Pharmaceutical Preparations

Datatype

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [2,3]
C0013227
must not have had more than one episode of severe hypoglycemia in the past 6 months
Beschrijving

Hypoglycemia Severe | Episode Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C1265611
must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
Beschrijving

Hematological Disease | Disease Oncologic | Kidney Disease | Heart Disease | Liver disease | Gastrointestinal Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205478
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0017178
must not be pregnant or intend to get pregnant during the course of the study
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
Terug naar het begin van de pagina

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00560417

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial