ID

38694

Description

A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01469065

Link

https://clinicaltrials.gov/show/NCT01469065

Keywords

Versions (1)
  1. 10/30/19 10/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 30, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Diabetes Mellitus, Type 2 NCT01469065

English

Eligibility Diabetes Mellitus, Type 2 NCT01469065

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes mellitus who are taking either no medication for the treatment of diabetes (diet/exercise therapy only), or who are taking only a single oral anti-diabetic drug (oad) that can be temporarily discontinued for approximately 8-10 weeks. for those taking a single oad, treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 3 months prior to screening. oad medications that are acceptable to be discontinued include: a sulfonylurea (su), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase 4 inhibitor (dpp-4i), or an alpha glucosidase inhibitor.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Pharmaceutical Preparations Absent | Diet therapy | Exercise | Antidiabetic Oral Single | Treatment Stable | Treatment unchanged | Dosage unchanged | Sulfonylurea | Meglitinide | Biguanides | Metformin | Dipeptidyl Peptidase-4 Inhibitor | alpha-Glucosidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0015259
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C1527415
UMLS CUI [5,3]
C0205171
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0205360
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0442739
UMLS CUI [8,1]
C0178602
UMLS CUI [8,2]
C0442739
UMLS CUI [9]
C0038766
UMLS CUI [10]
C0065880
UMLS CUI [11]
C0005382
UMLS CUI [12]
C0025598
UMLS CUI [13]
C3537225
UMLS CUI [14]
C1299007
body mass index (bmi) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).
Description

Body mass index | Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
hba1c >/=7% and </=10% if the patient is on diet/exercise therapy only and does not require any oad discontinuation. hba1c >/=6.5% and </=9% if the patient requires to be washed off an oad.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence or history of diabetic complications with significant end organ damage.
Description

Complications of Diabetes Mellitus | End organ damage

Data type

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0743496
history of stroke or transient ischemic attack.
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
history of myocardial infarction.
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
history of coronary artery bypass graft or stent implantation.
Description

Coronary Artery Bypass Surgery | Placement of stent

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C0522776
clinically significant peripheral vascular disease.
Description

Peripheral Vascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0085096
any history or clinical evidence of congestive heart failure, nyha classes ii iv.
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
current history of angina/unstable angina.
Description

Angina Pectoris | Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C0002965
one or more episodes of hypoglycemia within the last 3 months, or two or more episodes of hypoglycemia within the last 6 months.
Description

Episode Quantity Hypoglycemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020615
a positive urine drug screen.
Description

Urine drug screen positive

Data type

boolean

Alias
UMLS CUI [1]
C0743300
use of tobacco or nicotine-containing products in excess of the equivalent of 10 cigarettes per day.
Description

Tobacco use Excessive | Use of Nicotine product Excessive | Equivalent Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0442802
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0028040
UMLS CUI [2,3]
C0442802
UMLS CUI [3,1]
C0205163
UMLS CUI [3,2]
C3694146
blood pressure >/=160 mm hg (systolic) or >/=100 mm hg (diastolic), following at least 5 minutes of rest.
Description

Systolic Pressure | Diastolic blood pressure | Status post Rest Number of minutes

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0035253
UMLS CUI [3,3]
C1562039
pregnant or nursing females; females of childbearing potential.
Description

Pregnancy | Breast Feeding | Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
Back to the top of the page

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01469065

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Pharmaceutical Preparations Absent | Diet therapy | Exercise | Antidiabetic Oral Single | Treatment Stable | Treatment unchanged | Dosage unchanged | Sulfonylurea | Meglitinide | Biguanides | Metformin | Dipeptidyl Peptidase-4 Inhibitor | alpha-Glucosidase Inhibitors
Item
patients with type 2 diabetes mellitus who are taking either no medication for the treatment of diabetes (diet/exercise therapy only), or who are taking only a single oral anti-diabetic drug (oad) that can be temporarily discontinued for approximately 8-10 weeks. for those taking a single oad, treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 3 months prior to screening. oad medications that are acceptable to be discontinued include: a sulfonylurea (su), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase 4 inhibitor (dpp-4i), or an alpha glucosidase inhibitor.
boolean
C0011860 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0205171 (UMLS CUI [5,3])
C0087111 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7,1])
C0442739 (UMLS CUI [7,2])
C0178602 (UMLS CUI [8,1])
C0442739 (UMLS CUI [8,2])
C0038766 (UMLS CUI [9])
C0065880 (UMLS CUI [10])
C0005382 (UMLS CUI [11])
C0025598 (UMLS CUI [12])
C3537225 (UMLS CUI [13])
C1299007 (UMLS CUI [14])
Body mass index | Body Weight
Item
body mass index (bmi) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
hba1c >/=7% and </=10% if the patient is on diet/exercise therapy only and does not require any oad discontinuation. hba1c >/=6.5% and </=9% if the patient requires to be washed off an oad.
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Complications of Diabetes Mellitus | End organ damage
Item
evidence or history of diabetic complications with significant end organ damage.
boolean
C0342257 (UMLS CUI [1])
C0743496 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack
Item
history of stroke or transient ischemic attack.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Myocardial Infarction
Item
history of myocardial infarction.
boolean
C0027051 (UMLS CUI [1])
Coronary Artery Bypass Surgery | Placement of stent
Item
history of coronary artery bypass graft or stent implantation.
boolean
C0010055 (UMLS CUI [1])
C0522776 (UMLS CUI [2])
Peripheral Vascular Disease
Item
clinically significant peripheral vascular disease.
boolean
C0085096 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
any history or clinical evidence of congestive heart failure, nyha classes ii iv.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina Pectoris | Angina, Unstable
Item
current history of angina/unstable angina.
boolean
C0002962 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Episode Quantity Hypoglycemia
Item
one or more episodes of hypoglycemia within the last 3 months, or two or more episodes of hypoglycemia within the last 6 months.
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
Urine drug screen positive
Item
a positive urine drug screen.
boolean
C0743300 (UMLS CUI [1])
Tobacco use Excessive | Use of Nicotine product Excessive | Equivalent Number of cigarettes per day
Item
use of tobacco or nicotine-containing products in excess of the equivalent of 10 cigarettes per day.
boolean
C0543414 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0028040 (UMLS CUI [2,2])
C0442802 (UMLS CUI [2,3])
C0205163 (UMLS CUI [3,1])
C3694146 (UMLS CUI [3,2])
Systolic Pressure | Diastolic blood pressure | Status post Rest Number of minutes
Item
blood pressure >/=160 mm hg (systolic) or >/=100 mm hg (diastolic), following at least 5 minutes of rest.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0035253 (UMLS CUI [3,2])
C1562039 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Childbearing Potential
Item
pregnant or nursing females; females of childbearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial