ID

43897

Description

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

Link

https://clinicaltrials.gov/show/NCT00422487

Keywords

  1. 7/1/17 7/1/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT00422487

Eligibility Type 2 Diabetes Mellitus NCT00422487

Inclusion Criteria
Description

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®
Description

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

Data type

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.
Description

Female Sterilization | Postmenopausal state

Data type

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.
Description

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

Data type

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.
Description

Body mass index

Data type

boolean

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

Plasma fasting glucose measurement

Data type

boolean

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

Glycosylated hemoglobin A

Data type

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.
Description

ECG normal | Chest X-ray normal

Data type

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.
Description

Blood Pressure | Hypertensive disease Controlled by Pharmaceutical Preparations

Data type

boolean

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

Exclusion Criteria

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

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

Data type

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.
Description

Thiazolidinediones | Actos | Avandia

Data type

boolean

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

Thiazolidinediones Discontinued Due to Lack of Efficacy

Data type

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.
Description

Congestive heart failure Disease length

Data type

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.
Description

Lung diseases | Myocardial Infarction | Cerebrovascular accident | Nephrotic Syndrome

Data type

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).
Description

Malignant Neoplasms | Basal cell carcinoma Resected Excluded

Data type

boolean

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

Communicable Diseases

Data type

boolean

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

Antilipemic agent Changed

Data type

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].
Description

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

Data type

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.
Description

Phenytoin Expected

Data type

boolean

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

allergy to nonsteroidal anti-inflammatory agents

Data type

boolean

Alias
UMLS CUI [1]
C0746949

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00422487

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

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