ID

33152

Description

Exeantide in Type 2 Diabetes on Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT01154933

Link

https://clinicaltrials.gov/show/NCT01154933

Keywords

Versions (1)
  1. 11/29/18 11/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT01154933

English

Eligibility Type 2 Diabetes NCT01154933

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females 20-75 years of age inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
on insulin therapy
Description

Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0557978
hba1c ≥7.5% and ≤ 9%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi ≥ 30 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
subjects on statins, ace inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.
Description

Statins Dose Stable | Angiotensin-Converting Enzyme Inhibitors Dose Stable | Metformin Dose Stable | Thiazolidinediones Dose Stable | Antioxidants Dose Stable | Pharmaceutical Preparations Dose unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0003015
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1257987
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0003402
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0442739
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
Description

Event Coronary | Procedures on Coronary Arteries | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Operative Surgical Procedures | Coronary angioplasty

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1522318
UMLS CUI [2]
C0869781
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0010055
UMLS CUI [6]
C0543467
UMLS CUI [7]
C0190211
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
hepatic disease (abnormal lft's)
Description

Liver diseases | Liver function tests abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151766
use of dpp4 inhibitors.
Description

Dipeptidyl-Peptidase IV Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1827106
renal impairment (serum creatinine > 1.5)
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
participation in any other concurrent clinical trial
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
any other life-threatening, non-cardiac disease
Description

Life threatening illness | Exception Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
uncontrolled hypertension (bp > 160/100 mm of hg)
Description

Uncontrolled hypertension | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
congestive heart failure.
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
use of an investigational agent or therapeutic regimen within 30 days of study
Description

Investigational New Drugs | Therapies, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
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Similar models

Eligibility Type 2 Diabetes NCT01154933

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males or females 20-75 years of age inclusive.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Insulin regime
Item
on insulin therapy
boolean
C0557978 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c ≥7.5% and ≤ 9%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi ≥ 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Statins Dose Stable | Angiotensin-Converting Enzyme Inhibitors Dose Stable | Metformin Dose Stable | Thiazolidinediones Dose Stable | Antioxidants Dose Stable | Pharmaceutical Preparations Dose unchanged
Item
subjects on statins, ace inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.
boolean
C0360714 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1257987 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0003402 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0442739 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Event Coronary | Procedures on Coronary Arteries | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Operative Surgical Procedures | Coronary angioplasty
Item
coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
boolean
C0441471 (UMLS CUI [1,1])
C1522318 (UMLS CUI [1,2])
C0869781 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C0543467 (UMLS CUI [6])
C0190211 (UMLS CUI [7])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Liver diseases | Liver function tests abnormal
Item
hepatic disease (abnormal lft's)
boolean
C0023895 (UMLS CUI [1])
C0151766 (UMLS CUI [2])
Dipeptidyl-Peptidase IV Inhibitors
Item
use of dpp4 inhibitors.
boolean
C1827106 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum
Item
renal impairment (serum creatinine > 1.5)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in any other concurrent clinical trial
boolean
C2348568 (UMLS CUI [1])
Life threatening illness | Exception Heart Disease
Item
any other life-threatening, non-cardiac disease
boolean
C3846017 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
Uncontrolled hypertension | Blood pressure determination
Item
uncontrolled hypertension (bp > 160/100 mm of hg)
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
Congestive heart failure
Item
congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
Investigational New Drugs | Therapies, Investigational
Item
use of an investigational agent or therapeutic regimen within 30 days of study
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
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