ID

29103

Description

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

Keywords

Versions (1)
  1. 2/24/18 2/24/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 24, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00560417

English

Eligibility Diabetes Mellitus, Type 2 NCT00560417

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

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

Age

Data type

boolean

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

Exenatide Frequency U/day

Data type

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
Description

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

Data type

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%
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
Exclusion Criteria
Description

Exclusion Criteria

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

Insulin Regular

Data type

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
Description

Hypoglycemic Agents | Exception Inclusion criteria Pharmaceutical Preparations

Data type

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
Description

Hypoglycemia Severe | Episode Quantity

Data type

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
Description

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

Data type

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
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00560417

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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