ID

25545

Description

Randomized, Double-Blind Active Comparator-Controlled Study of Rivoglitazone in Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00484198

Link

https://clinicaltrials.gov/show/NCT00484198

Keywords

  1. 9/5/17 9/5/17 -
Uploaded on

September 5, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT00484198

Eligibility Type 2 Diabetes Mellitus NCT00484198

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
male or female at least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
a1c > 7% and less or equal to 8.5%
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
non-fasting c-peptide > 0.5ng/ml
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
current monotherapy treatment with stable dose of approved non-tzd antihyperglycemic medication for greater or equal to 3 months prior to screening or
Description

Hypoglycemic Agents Dose Stable | Exception Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1257987
untreated with any antihyperglycemic agent during 2 months prior to screening
Description

Hypoglycemic Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes or ketoacidosis
Description

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
history of long-term therapy with insulin
Description

Insulin regime Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0443252
bmi > 45 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
known history of chf
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
impaired hepatic function
Description

Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
history of prior treatment failure with, or intolerance of, a tzd
Description

Thiazolidinediones | Absent response to treatment | Intolerance to Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0438286
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C1257987
contraindication to treatment with pioglitazone
Description

Medical contraindication pioglitazone

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0071097
treatment with fibrates
Description

Fibrates

Data type

boolean

Alias
UMLS CUI [1]
C1449704
if untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as sole treatment for type 2 diabetes
Description

Oral hypoglycemic Absent | Dietary Modification Non-Insulin-Dependent Diabetes Mellitus | Exercise Modification Non-Insulin-Dependent Diabetes Mellitus | Therapeutic procedure failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0086153
UMLS CUI [2,2]
C0011860
UMLS CUI [3,1]
C0015259
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0011860
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0231175

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00484198

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
male or female at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
a1c > 7% and less or equal to 8.5%
boolean
C0019018 (UMLS CUI [1])
C-peptide measurement
Item
non-fasting c-peptide > 0.5ng/ml
boolean
C0202100 (UMLS CUI [1])
Hypoglycemic Agents Dose Stable | Exception Thiazolidinediones
Item
current monotherapy treatment with stable dose of approved non-tzd antihyperglycemic medication for greater or equal to 3 months prior to screening or
boolean
C0020616 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C1257987 (UMLS CUI [2,2])
Hypoglycemic Agents Absent
Item
untreated with any antihyperglycemic agent during 2 months prior to screening
boolean
C0020616 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
history of type 1 diabetes or ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
Insulin regime Long-term
Item
history of long-term therapy with insulin
boolean
C0557978 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
Body mass index
Item
bmi > 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Congestive heart failure
Item
known history of chf
boolean
C0018802 (UMLS CUI [1])
Liver Dysfunction
Item
impaired hepatic function
boolean
C0086565 (UMLS CUI [1])
Thiazolidinediones | Absent response to treatment | Intolerance to Thiazolidinediones
Item
history of prior treatment failure with, or intolerance of, a tzd
boolean
C1257987 (UMLS CUI [1])
C0438286 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C1257987 (UMLS CUI [3,2])
Medical contraindication pioglitazone
Item
contraindication to treatment with pioglitazone
boolean
C1301624 (UMLS CUI [1,1])
C0071097 (UMLS CUI [1,2])
Fibrates
Item
treatment with fibrates
boolean
C1449704 (UMLS CUI [1])
Oral hypoglycemic Absent | Dietary Modification Non-Insulin-Dependent Diabetes Mellitus | Exercise Modification Non-Insulin-Dependent Diabetes Mellitus | Therapeutic procedure failed
Item
if untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as sole treatment for type 2 diabetes
boolean
C0359086 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0086153 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
C0015259 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0011860 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])

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