ID

38694

Beschreibung

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

Stichworte

Versionen (1)
  1. 30.10.19 30.10.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

30. Oktober 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01469065

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT01469065

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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).
Beschreibung

Body mass index | Body Weight

Datentyp

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.
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Complications of Diabetes Mellitus | End organ damage

Datentyp

boolean

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

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

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

Myocardial Infarction

Datentyp

boolean

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

Coronary Artery Bypass Surgery | Placement of stent

Datentyp

boolean

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

Peripheral Vascular Disease

Datentyp

boolean

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

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

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

Angina Pectoris | Angina, Unstable

Datentyp

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.
Beschreibung

Episode Quantity Hypoglycemia

Datentyp

boolean

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

Urine drug screen positive

Datentyp

boolean

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

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT01469065

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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