ID

32751

Description

Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00694057

Link

https://clinicaltrials.gov/show/NCT00694057

Keywords

Versions (1)
  1. 11/14/18 11/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00694057

English

Eligibility Type 2 Diabetes Mellitus NCT00694057

1 forms  
Criteria
Description

Criteria

patient with a diagnosis of type 2 diabetes mellitus (t2dm)
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
patient must be a) on a stable dose of metformin as monotherapy for at least 10 weeks prior to screening; or b) drug-naive, defined as never having received drug treatment for t2dm or not having received antidiabetic drug therapy during the 3 months prior to screening.
Description

Metformin Dose Stable | Pharmacotherapy Absent Non-Insulin-Dependent Diabetes Mellitus | Antidiabetics Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0011860
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C0332197
patient with a fasting blood glucose level of ≤ 225 mg/dl at screening (≤ 255 mg/dl for drug-naive patients);
Description

Fasting blood glucose measurement | Pharmacotherapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0332197
patient with hba1c levels >7.5% (7.0 - 10.5% for drug-naive patients) at screening;
Description

Hemoglobin A1c measurement | Pharmacotherapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0332197
patient with bmi 28-37 kg/m2 for females 28-39 kg/m2 for males
Description

Body mass index | Gender

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0079399
main exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities within 6 months prior to screening;
Description

Cardiovascular Disease | Coronary Artery Disease | Liver Dysfunction | Abnormal breathing | Abnormal renal function

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0086565
UMLS CUI [4]
C1260922
UMLS CUI [5]
C0151746
patient with unstable diabetic complications requiring treatment or ongoing active intervention;
Description

Complications of Diabetes Mellitus Unstable Treatment required for | Intervention Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1514873
patient with a history of long term insulin therapy within the past year;
Description

Insulin regime Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0443252
patient who has had therapy with rosiglitazone, pioglitazone, exendin-4 or sitagliptin, alone or in combination within 6 months prior to screening;
Description

rosiglitazone | pioglitazone | exenatide | sitagliptin | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0071097
UMLS CUI [3]
C0167117
UMLS CUI [4]
C1565750
UMLS CUI [5]
C0009429
patient who has any clinically significant abnormalities in laboratory results at screening;
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00694057

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Diabetes Mellitus, Non-Insulin-Dependent
Item
patient with a diagnosis of type 2 diabetes mellitus (t2dm)
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable | Pharmacotherapy Absent Non-Insulin-Dependent Diabetes Mellitus | Antidiabetics Absent
Item
patient must be a) on a stable dose of metformin as monotherapy for at least 10 weeks prior to screening; or b) drug-naive, defined as never having received drug treatment for t2dm or not having received antidiabetic drug therapy during the 3 months prior to screening.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011860 (UMLS CUI [2,3])
C0935929 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Fasting blood glucose measurement | Pharmacotherapy Absent
Item
patient with a fasting blood glucose level of ≤ 225 mg/dl at screening (≤ 255 mg/dl for drug-naive patients);
boolean
C0428568 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hemoglobin A1c measurement | Pharmacotherapy Absent
Item
patient with hba1c levels >7.5% (7.0 - 10.5% for drug-naive patients) at screening;
boolean
C0474680 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Body mass index | Gender
Item
patient with bmi 28-37 kg/m2 for females 28-39 kg/m2 for males
boolean
C1305855 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Cardiovascular Disease | Coronary Artery Disease | Liver Dysfunction | Abnormal breathing | Abnormal renal function
Item
patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities within 6 months prior to screening;
boolean
C0007222 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C1260922 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
Complications of Diabetes Mellitus Unstable Treatment required for | Intervention Required
Item
patient with unstable diabetic complications requiring treatment or ongoing active intervention;
boolean
C0342257 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C0184661 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Insulin regime Long-term
Item
patient with a history of long term insulin therapy within the past year;
boolean
C0557978 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
rosiglitazone | pioglitazone | exenatide | sitagliptin | Combined Modality Therapy
Item
patient who has had therapy with rosiglitazone, pioglitazone, exendin-4 or sitagliptin, alone or in combination within 6 months prior to screening;
boolean
C0289313 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
C0167117 (UMLS CUI [3])
C1565750 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
Laboratory test result abnormal
Item
patient who has any clinically significant abnormalities in laboratory results at screening;
boolean
C0438215 (UMLS CUI [1])
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