ID

29186

Beschreibung

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00946972

Link

https://clinicaltrials.gov/show/NCT00946972

Stichworte

Versionen (1)
  1. 05.03.18 05.03.18 -
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See clinicaltrials.gov

Hochgeladen am

5. März 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00946972

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00946972

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus
Beschreibung

Gender | Postmenopausal state | Female Sterilization | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0011860
medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ecg performed at screening
Beschreibung

Stable status Medical | Physical Examination | Medical History | Laboratory Results | Taking vital signs | Electrocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205476
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0262926
UMLS CUI [4]
C1254595
UMLS CUI [5]
C0150404
UMLS CUI [6]
C1623258
body mass index (bmi) between 22 and 39.9 kg/m2, inclusive
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
on a generally stable antihyperglycemic agent regimen (i.e. with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to screening visit, including volunteers who are: (a) not currently on antihyperglycemic therapy and have an hba1c >=7.0 % and <=10%, or (b) on a single oral antihyperglycemic agent [metformin, a sunfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a dpp-iv inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)] and have an hba1c >=6.5% and <=9.5%, or (c) on low-dose dual oral agent therapy (i.e., <50% maximum labeled doses of both agents) and have an hba1c >=6.5% and <=9.5%
Beschreibung

Hypoglycemic Agents Stable | Glucohemoglobin measurement | Oral hypoglycemic Single | Metformin | Sulfonylurea | Meglitinide | repaglinide | nateglinide | Dipeptidyl Peptidase-4 Inhibitor | sitagliptin | vildagliptin | alpha-Glucosidase Inhibitors | Acarbose | Oral medication Double Low-Dose Treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0202054
UMLS CUI [3,1]
C0359086
UMLS CUI [3,2]
C0205171
UMLS CUI [4]
C0025598
UMLS CUI [5]
C0038766
UMLS CUI [6]
C0065880
UMLS CUI [7]
C0246689
UMLS CUI [8]
C0903898
UMLS CUI [9]
C3537225
UMLS CUI [10]
C1565750
UMLS CUI [11]
C1570906
UMLS CUI [12]
C1299007
UMLS CUI [13]
C0050393
UMLS CUI [14,1]
C0175795
UMLS CUI [14,2]
C0205173
UMLS CUI [14,3]
C1708745
on day -2 (two days prior to study drug administration), fpg concentrations between 120 mg/dl and 260 mg/dl, inclusive
Beschreibung

Plasma fasting glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
taking non-oral antihyperglycemic agent (e.g., insulin, exenatide or other glp-1 analogues), or taking a thiazolidinedione (i.e., a pparg agonist) within 3 months of the screening visit
Beschreibung

Hypoglycemic Agents | Insulin | exenatide | GLP-1 Analogue | Thiazolidinediones | Peroxisome Proliferator-Activated Receptor Gamma agonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0167117
UMLS CUI [4]
C3273809
UMLS CUI [5]
C1257987
UMLS CUI [6,1]
C3887582
UMLS CUI [6,2]
C0243192
history of a recent severe hypoglycemic episode, recurrent hypoglycemic episodes (i.e., within the past year), or a history of hypoglycemic unawareness
Beschreibung

Hypoglycaemic episode Severe | Hypoglycaemic episode Recurrent | Loss of hypoglycemic warning

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C2945760
UMLS CUI [3]
C0342317
history of clinically significant diabetic complications, including retinopathy, nephropathy, neuropathy or gastroparesis
Beschreibung

Complications of Diabetes Mellitus | Retinal Diseases | Kidney Diseases | Neuropathy | Gastroparesis

Datentyp

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0035309
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0442874
UMLS CUI [5]
C0152020
positive test for alcohol and/or drugs of abuse
Beschreibung

Substance Use Disorders Test Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C1514241
psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
Beschreibung

Mental problem Informed Consent Invalid | Mental problem Protocol Compliance Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0848067
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C1547465
UMLS CUI [2,1]
C0848067
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements
Beschreibung

Condition compromises Study Subject Health | Condition compromises Clinical Trial | Condition Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0681850
UMLS CUI [1,4]
C0018684
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0525058
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00946972

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Postmenopausal state | Female Sterilization | Diabetes Mellitus, Non-Insulin-Dependent
Item
males or postmenopausal or surgically sterilized females, who have type 2 diabetes mellitus
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
Stable status Medical | Physical Examination | Medical History | Laboratory Results | Taking vital signs | Electrocardiography
Item
medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and ecg performed at screening
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C1254595 (UMLS CUI [4])
C0150404 (UMLS CUI [5])
C1623258 (UMLS CUI [6])
Body mass index
Item
body mass index (bmi) between 22 and 39.9 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Hypoglycemic Agents Stable | Glucohemoglobin measurement | Oral hypoglycemic Single | Metformin | Sulfonylurea | Meglitinide | repaglinide | nateglinide | Dipeptidyl Peptidase-4 Inhibitor | sitagliptin | vildagliptin | alpha-Glucosidase Inhibitors | Acarbose | Oral medication Double Low-Dose Treatment
Item
on a generally stable antihyperglycemic agent regimen (i.e. with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to screening visit, including volunteers who are: (a) not currently on antihyperglycemic therapy and have an hba1c >=7.0 % and <=10%, or (b) on a single oral antihyperglycemic agent [metformin, a sunfonylurea, a meglitinide (e.g., repaglininide or nateglinide), a dpp-iv inhibitor (sitagliptin or vildagliptin), or an alpha-glucosidase inhibitor (e.g., acarbose)] and have an hba1c >=6.5% and <=9.5%, or (c) on low-dose dual oral agent therapy (i.e., <50% maximum labeled doses of both agents) and have an hba1c >=6.5% and <=9.5%
boolean
C0020616 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
C0359086 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C0065880 (UMLS CUI [6])
C0246689 (UMLS CUI [7])
C0903898 (UMLS CUI [8])
C3537225 (UMLS CUI [9])
C1565750 (UMLS CUI [10])
C1570906 (UMLS CUI [11])
C1299007 (UMLS CUI [12])
C0050393 (UMLS CUI [13])
C0175795 (UMLS CUI [14,1])
C0205173 (UMLS CUI [14,2])
C1708745 (UMLS CUI [14,3])
Plasma fasting glucose measurement
Item
on day -2 (two days prior to study drug administration), fpg concentrations between 120 mg/dl and 260 mg/dl, inclusive
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypoglycemic Agents | Insulin | exenatide | GLP-1 Analogue | Thiazolidinediones | Peroxisome Proliferator-Activated Receptor Gamma agonists
Item
taking non-oral antihyperglycemic agent (e.g., insulin, exenatide or other glp-1 analogues), or taking a thiazolidinedione (i.e., a pparg agonist) within 3 months of the screening visit
boolean
C0020616 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0167117 (UMLS CUI [3])
C3273809 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
C3887582 (UMLS CUI [6,1])
C0243192 (UMLS CUI [6,2])
Hypoglycaemic episode Severe | Hypoglycaemic episode Recurrent | Loss of hypoglycemic warning
Item
history of a recent severe hypoglycemic episode, recurrent hypoglycemic episodes (i.e., within the past year), or a history of hypoglycemic unawareness
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0745153 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0342317 (UMLS CUI [3])
Complications of Diabetes Mellitus | Retinal Diseases | Kidney Diseases | Neuropathy | Gastroparesis
Item
history of clinically significant diabetic complications, including retinopathy, nephropathy, neuropathy or gastroparesis
boolean
C0342257 (UMLS CUI [1])
C0035309 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0442874 (UMLS CUI [4])
C0152020 (UMLS CUI [5])
Substance Use Disorders Test Positive
Item
positive test for alcohol and/or drugs of abuse
boolean
C0038586 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Mental problem Informed Consent Invalid | Mental problem Protocol Compliance Limited
Item
psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
boolean
C0848067 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1547465 (UMLS CUI [1,3])
C0848067 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Condition compromises Study Subject Health | Condition compromises Clinical Trial | Condition Preventing Protocol Compliance
Item
any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0018684 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
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