ID

29139

Beskrivning

A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione; ODM derived from: https://clinicaltrials.gov/show/NCT00743002

Länk

https://clinicaltrials.gov/show/NCT00743002

Nyckelord

Versioner (1)
  1. 2018-02-28 2018-02-28 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

28 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00743002

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00743002

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes for at least 6 months
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
treated with metformin and/or thiazolidinediones with stable dose for at least 3 months
Beskrivning

Metformin Dose Stable | Thiazolidinediones Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1257987
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
bmi of 21-45 kg/m2, inclusive
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
hba1c level of 7.50 - 10.00%, inclusive
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
if a female of childbearing potential, willing to utilize contraception from screening through 4 weeks after the last dose of study drug
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with insulin, sulfonylurea, dpp-4 inhibitors, symlin® and/or glp-1 analogues ≤ 3 months prior to the screening
Beskrivning

Insulin | Sulfonylurea | Dipeptidyl-Peptidase IV Inhibitors | Symlin | GLP-1 Analogue

Datatyp

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0038766
UMLS CUI [3]
C1827106
UMLS CUI [4]
C1174780
UMLS CUI [5]
C3273809
severe hypoglycemia ≤ 60 days prior to the screening visit or currently diagnosed with having hypoglycemia unawareness
Beskrivning

Hypoglycemia Severe | Loss of hypoglycemic warning

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0342317
history of peptic ulcer(s) and/or gastrointestinal bleeding/perforation
Beskrivning

Gastric ulcer | Gastrointestinal Hemorrhage | Gastrointestinal perforation

Datatyp

boolean

Alias
UMLS CUI [1]
C0038358
UMLS CUI [2]
C0017181
UMLS CUI [3]
C0151664
previous gastric surgery, including gastric bypass, or has gastric bypass/other major surgery planned to occur during the 10 month trial
Beskrivning

Operation on stomach | Gastric Bypass | Gastric Bypass Planned | Major surgery Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0192398
UMLS CUI [2]
C0017125
UMLS CUI [3,1]
C0017125
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0679637
UMLS CUI [4,2]
C1301732
myocardial infarction within the last 2 years, current congestive heart failure with nyha class 2 or greater, or chronic atrial fibrillation
Beskrivning

Myocardial Infarction | Congestive heart failure New York Heart Association Classification | Chronic atrial fibrillation

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0694539
current clinically significant and/or chronic illness
Beskrivning

Illness Clinical Significance | Chronic disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0008679
takes regular courses of non-steroidal anti-inflammatory drugs (nsaids). if these medications are discontinued upon starting screening procedures and are not planned to be regularly used during the trial, the patient will be allowed to enter the study
Beskrivning

Non-Steroidal Anti-Inflammatory Agents Regular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0205272
use of systemic corticosteroids (oral, suppository, injected). use of inhaled or topical corticosteroids is permitted
Beskrivning

CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Suppository | CORTICOSTEROIDS FOR SYSTEMIC USE Injection | CORTICOSTEROIDS FOR SYSTEMIC USE Inhalation allowed | Topical corticosteroids allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C3653708
UMLS CUI [2,2]
C0038854
UMLS CUI [3,1]
C3653708
UMLS CUI [3,2]
C1828121
UMLS CUI [4,1]
C3653708
UMLS CUI [4,2]
C0205535
UMLS CUI [4,3]
C0683607
UMLS CUI [5,1]
C0304604
UMLS CUI [5,2]
C0683607
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00743002

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes for at least 6 months
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable | Thiazolidinediones Dose Stable
Item
treated with metformin and/or thiazolidinediones with stable dose for at least 3 months
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1257987 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Body mass index
Item
bmi of 21-45 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c level of 7.50 - 10.00%, inclusive
boolean
C0202054 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
if a female of childbearing potential, willing to utilize contraception from screening through 4 weeks after the last dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Insulin | Sulfonylurea | Dipeptidyl-Peptidase IV Inhibitors | Symlin | GLP-1 Analogue
Item
treatment with insulin, sulfonylurea, dpp-4 inhibitors, symlin® and/or glp-1 analogues ≤ 3 months prior to the screening
boolean
C0021641 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C1827106 (UMLS CUI [3])
C1174780 (UMLS CUI [4])
C3273809 (UMLS CUI [5])
Hypoglycemia Severe | Loss of hypoglycemic warning
Item
severe hypoglycemia ≤ 60 days prior to the screening visit or currently diagnosed with having hypoglycemia unawareness
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0342317 (UMLS CUI [2])
Gastric ulcer | Gastrointestinal Hemorrhage | Gastrointestinal perforation
Item
history of peptic ulcer(s) and/or gastrointestinal bleeding/perforation
boolean
C0038358 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0151664 (UMLS CUI [3])
Operation on stomach | Gastric Bypass | Gastric Bypass Planned | Major surgery Planned
Item
previous gastric surgery, including gastric bypass, or has gastric bypass/other major surgery planned to occur during the 10 month trial
boolean
C0192398 (UMLS CUI [1])
C0017125 (UMLS CUI [2])
C0017125 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0679637 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Myocardial Infarction | Congestive heart failure New York Heart Association Classification | Chronic atrial fibrillation
Item
myocardial infarction within the last 2 years, current congestive heart failure with nyha class 2 or greater, or chronic atrial fibrillation
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0694539 (UMLS CUI [3])
Illness Clinical Significance | Chronic disease
Item
current clinically significant and/or chronic illness
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
Non-Steroidal Anti-Inflammatory Agents Regular
Item
takes regular courses of non-steroidal anti-inflammatory drugs (nsaids). if these medications are discontinued upon starting screening procedures and are not planned to be regularly used during the trial, the patient will be allowed to enter the study
boolean
C0003211 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Suppository | CORTICOSTEROIDS FOR SYSTEMIC USE Injection | CORTICOSTEROIDS FOR SYSTEMIC USE Inhalation allowed | Topical corticosteroids allowed
Item
use of systemic corticosteroids (oral, suppository, injected). use of inhaled or topical corticosteroids is permitted
boolean
C3653708 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2,1])
C0038854 (UMLS CUI [2,2])
C3653708 (UMLS CUI [3,1])
C1828121 (UMLS CUI [3,2])
C3653708 (UMLS CUI [4,1])
C0205535 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
C0304604 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
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