ID

43897

Beskrivning

Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00422487

Länk

https://clinicaltrials.gov/show/NCT00422487

Nyckelord

Versioner (2)
  1. 2017-07-01 2017-07-01 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Type 2 Diabetes Mellitus NCT00422487

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00422487

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes previously controlled with up to one or two non-tzd hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., prandin®, starlix®), metformin (e.g., glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or byetta®
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Quantity | Thiazolidinediones Excluded | Sulfonylurea Compounds | Glyburide | Glipizide | glimepiride | Meglitinide | Prandin | Starlix | Metformin | Glucophage | alpha-Glucosidase Inhibitors | Acarbose | miglitol | Byetta

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0020616
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1257987
UMLS CUI [3,2]
C2828389
UMLS CUI [4]
C0038766
UMLS CUI [5]
C0017628
UMLS CUI [6]
C0017642
UMLS CUI [7]
C0061323
UMLS CUI [8]
C0065880
UMLS CUI [9]
C0722725
UMLS CUI [10]
C1323198
UMLS CUI [11]
C0025598
UMLS CUI [12]
C0591573
UMLS CUI [13]
C1299007
UMLS CUI [14]
C0050393
UMLS CUI [15]
C0066535
UMLS CUI [16]
C1636686
all female patients must be either surgically sterile or post-menopausal.
Beskrivning

Female Sterilization | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
Beskrivning

Gender Male Condoms | Partner Female Childbearing Potential | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0009653
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0086287
UMLS CUI [2,3]
C3831118
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
bmi 24-44 kg/m2.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
patients must have a fpg ≤ 200 mg/dl at screening.
Beskrivning

Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583513
patients must have hemoglobin a1c ≥ 6.5%, ≤ 10.0% at screening.
Beskrivning

Glycosylated hemoglobin A

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018
electrocardiogram (ecg) and chest x-ray must be normal, or considered not clinically significant, for participation in this study.
Beskrivning

ECG normal | Chest X-ray normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0522054
UMLS CUI [2]
C0239026
patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication.
Beskrivning

Blood Pressure | Hypertensive disease Controlled by Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1]
C0005823
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0332298
UMLS CUI [2,3]
C0013227
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0030305
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0030279
history of tzd use (actos or avandia) within 6 months of screening visit.
Beskrivning

Thiazolidinediones | Actos | Avandia

Datatyp

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0875954
UMLS CUI [3]
C0875967
history of tzd discontinuation due to lack of efficacy.
Beskrivning

Thiazolidinediones Discontinued Due to Lack of Efficacy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1257987
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0235828
history of congestive heart failure within last 5 years.
Beskrivning

Congestive heart failure Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0872146
history of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
Beskrivning

Lung diseases | Myocardial Infarction | Cerebrovascular accident | Nephrotic Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0027726
malignancy within the last 5 years (except resected basal cell carcinoma).
Beskrivning

Malignant Neoplasms | Basal cell carcinoma Resected Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1521996
UMLS CUI [2,3]
C2828389
ongoing active infection.
Beskrivning

Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
change in treatment with lipid-lowering agent within 7 days of screening visit.
Beskrivning

Antilipemic agent Changed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086440
UMLS CUI [1,2]
C0392747
current or expected requirement for anticoagulant therapy [except for low-dose aspirin ≤ 325 mg/d or plavix® ≤ 75 mg/d].
Beskrivning

Anticoagulant therapy Requirement Expected | Aspirin Low Dose Excluded | Plavix Dosage Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C2608320
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0633084
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C2828389
current or expected treatment with phenytoin for the duration of the study.
Beskrivning

Phenytoin Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031507
UMLS CUI [1,2]
C1517001
known hypersensitivity to nsaids.
Beskrivning

allergy to nonsteroidal anti-inflammatory agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0746949
Tillbaka till toppen

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00422487

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Hypoglycemic Agents Quantity | Thiazolidinediones Excluded | Sulfonylurea Compounds | Glyburide | Glipizide | glimepiride | Meglitinide | Prandin | Starlix | Metformin | Glucophage | alpha-Glucosidase Inhibitors | Acarbose | miglitol | Byetta
Item
type 2 diabetes previously controlled with up to one or two non-tzd hypoglycemic agents including sulfonylureas (e.g., glyburide, glipizide, glimeprimide), meglitinides (e.g., prandin®, starlix®), metformin (e.g., glucophage®), α-glucosidase inhibitors (e.g.,acarbose, miglitol) or byetta®
boolean
C0011860 (UMLS CUI [1])
C0020616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1257987 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4])
C0017628 (UMLS CUI [5])
C0017642 (UMLS CUI [6])
C0061323 (UMLS CUI [7])
C0065880 (UMLS CUI [8])
C0722725 (UMLS CUI [9])
C1323198 (UMLS CUI [10])
C0025598 (UMLS CUI [11])
C0591573 (UMLS CUI [12])
C1299007 (UMLS CUI [13])
C0050393 (UMLS CUI [14])
C0066535 (UMLS CUI [15])
C1636686 (UMLS CUI [16])
Female Sterilization | Postmenopausal state
Item
all female patients must be either surgically sterile or post-menopausal.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Gender Male Condoms | Partner Female Childbearing Potential | Childbearing Potential Contraceptive methods
Item
male patients with female partners of childbearing potential must agree to use condoms, or their partner must use a medically acceptable form of contraception.
boolean
C0079399 (UMLS CUI [1,1])
C0009653 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0086287 (UMLS CUI [2,2])
C3831118 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Body mass index
Item
bmi 24-44 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
patients must have a fpg ≤ 200 mg/dl at screening.
boolean
C0583513 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
patients must have hemoglobin a1c ≥ 6.5%, ≤ 10.0% at screening.
boolean
C0019018 (UMLS CUI [1])
ECG normal | Chest X-ray normal
Item
electrocardiogram (ecg) and chest x-ray must be normal, or considered not clinically significant, for participation in this study.
boolean
C0522054 (UMLS CUI [1])
C0239026 (UMLS CUI [2])
Blood Pressure | Hypertensive disease Controlled by Pharmaceutical Preparations
Item
patients must have a blood pressure ≤ 160/90 mm/hg including hypertensive patients controlled with medication.
boolean
C0005823 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0332298 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy
Item
history of type 1 diabetes or diabetes secondary to pancreatitis or pancreatectomy.
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0030305 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0030279 (UMLS CUI [3,3])
Thiazolidinediones | Actos | Avandia
Item
history of tzd use (actos or avandia) within 6 months of screening visit.
boolean
C1257987 (UMLS CUI [1])
C0875954 (UMLS CUI [2])
C0875967 (UMLS CUI [3])
Thiazolidinediones Discontinued Due to Lack of Efficacy
Item
history of tzd discontinuation due to lack of efficacy.
boolean
C1257987 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0235828 (UMLS CUI [1,4])
Congestive heart failure Disease length
Item
history of congestive heart failure within last 5 years.
boolean
C0018802 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Lung diseases | Myocardial Infarction | Cerebrovascular accident | Nephrotic Syndrome
Item
history of significant pulmonary disease, myocardial infarction, cerebrovascular accident, or nephrotic syndrome within last 1 year.
boolean
C0024115 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0027726 (UMLS CUI [4])
Malignant Neoplasms | Basal cell carcinoma Resected Excluded
Item
malignancy within the last 5 years (except resected basal cell carcinoma).
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1521996 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Communicable Diseases
Item
ongoing active infection.
boolean
C0009450 (UMLS CUI [1])
Antilipemic agent Changed
Item
change in treatment with lipid-lowering agent within 7 days of screening visit.
boolean
C0086440 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Anticoagulant therapy Requirement Expected | Aspirin Low Dose Excluded | Plavix Dosage Excluded
Item
current or expected requirement for anticoagulant therapy [except for low-dose aspirin ≤ 325 mg/d or plavix® ≤ 75 mg/d].
boolean
C0150457 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C2608320 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0633084 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
Phenytoin Expected
Item
current or expected treatment with phenytoin for the duration of the study.
boolean
C0031507 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
allergy to nonsteroidal anti-inflammatory agents
Item
known hypersensitivity to nsaids.
boolean
C0746949 (UMLS CUI [1])
Tillbaka till toppen 

Hjälp

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