ID

20671

Description

Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX); ODM derived from: https://clinicaltrials.gov/show/NCT00377858

Link

https://clinicaltrials.gov/show/NCT00377858

Keywords

Versions (1)
  1. 3/9/17 3/9/17 -
Uploaded on

March 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00377858

English

Eligibility Diabetes Mellitus, Type 2 NCT00377858

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
have been receiving oral antihyperglycemic medications (oam) without insulin including at least two of the following at maximally tolerated doses, and meet the minimum dosing criteria shown: metformin 1500 mg/day, sulfonylurea 1/2 the maximum daily dose, according to package insert, thiazolidinedione (tzd) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. the oams also must be used in accordance with the product label
Description

Hypoglycemic Agents Oral | Insulin | Metformin U/day | Sulfonylurea Daily Dose | Thiazolidinediones | pioglitazone U/day | rosiglitazone U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0021641
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0038766
UMLS CUI [4,2]
C2348070
UMLS CUI [5]
C1257987
UMLS CUI [6,1]
C0071097
UMLS CUI [6,2]
C0456683
UMLS CUI [7,1]
C0289313
UMLS CUI [7,2]
C0456683
have a hemoglobin a1c greater than or equal to 7.5% and less than or equal to 12.0%.
Description

Glycosylated hemoglobin A Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are taking a tzd dose greater than what is indicated in combination with insulin according to the tzd label.
Description

Thiazolidinediones High dose | Insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C1257987
UMLS CUI [1,2]
C0444956
UMLS CUI [2]
C0021641
are taking any other glucose-lowering agents not mentioned in inclusion criterion.
Description

Hypoglycemic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0020616
have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
Description

Acarbose | miglitol | Pramlintide | exenatide | repaglinide | nateglinide

Data type

boolean

Alias
UMLS CUI [1]
C0050393
UMLS CUI [2]
C0066535
UMLS CUI [3]
C0537551
UMLS CUI [4]
C0167117
UMLS CUI [5]
C0246689
UMLS CUI [6]
C0903898
have a body mass index greater than 40 kg/m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
have had more than one episode of severe hypoglycemia in the last24 weeks
Description

Hypoglycemia Severe Episode Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
are pregnant, intend to be pregnant during the course of the study or are breastfeeding
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
Description

Heart Disease | Kidney Disease | Hematological Disease | Malignant Neoplasm | Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0023895
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00377858

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hypoglycemic Agents Oral | Insulin | Metformin U/day | Sulfonylurea Daily Dose | Thiazolidinediones | pioglitazone U/day | rosiglitazone U/day
Item
have been receiving oral antihyperglycemic medications (oam) without insulin including at least two of the following at maximally tolerated doses, and meet the minimum dosing criteria shown: metformin 1500 mg/day, sulfonylurea 1/2 the maximum daily dose, according to package insert, thiazolidinedione (tzd) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. the oams also must be used in accordance with the product label
boolean
C0020616 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4,1])
C2348070 (UMLS CUI [4,2])
C1257987 (UMLS CUI [5])
C0071097 (UMLS CUI [6,1])
C0456683 (UMLS CUI [6,2])
C0289313 (UMLS CUI [7,1])
C0456683 (UMLS CUI [7,2])
Glycosylated hemoglobin A Percentage
Item
have a hemoglobin a1c greater than or equal to 7.5% and less than or equal to 12.0%.
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones High dose | Insulin
Item
are taking a tzd dose greater than what is indicated in combination with insulin according to the tzd label.
boolean
C1257987 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
Hypoglycemic Agents
Item
are taking any other glucose-lowering agents not mentioned in inclusion criterion.
boolean
C0020616 (UMLS CUI [1])
Acarbose | miglitol | Pramlintide | exenatide | repaglinide | nateglinide
Item
have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
boolean
C0050393 (UMLS CUI [1])
C0066535 (UMLS CUI [2])
C0537551 (UMLS CUI [3])
C0167117 (UMLS CUI [4])
C0246689 (UMLS CUI [5])
C0903898 (UMLS CUI [6])
Body mass index
Item
have a body mass index greater than 40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Hypoglycemia Severe Episode Quantity
Item
have had more than one episode of severe hypoglycemia in the last24 weeks
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
are pregnant, intend to be pregnant during the course of the study or are breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Heart Disease | Kidney Disease | Hematological Disease | Malignant Neoplasm | Liver disease
Item
have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
boolean
C0018799 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
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