ID

23276

Beschreibung

A Study in Type 2 Diabetic Patients With Repeated Doses of E1 in Combination With G1; ODM derived from: https://clinicaltrials.gov/show/NCT00239187

Link

https://clinicaltrials.gov/show/NCT00239187

Stichworte

Versionen (1)
  1. 02.07.17 02.07.17 -
Hochgeladen am

2. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00239187

Englisch

Eligibility Type 2 Diabetes NCT00239187

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained from participants
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
clinical diagnosis type 2 diabetes requiring treatment with metformin and/or tzd and who are otherwise healthy
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Treatment required for | Metformin | Thiazolidinediones | Healthy Volunteers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C0025598
UMLS CUI [3]
C1257987
UMLS CUI [4]
C1708335
on a stable metformin and/or tzd regimen for at least 60 days prior to screening
Beschreibung

Metformin | Thiazolidinediones | Regimen Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C1257987
UMLS CUI [3,1]
C0040808
UMLS CUI [3,2]
C0205360
maximum stimulated c-peptide level > 0.6 nmol/l (1.8 ng/ml)
Beschreibung

C-peptide level Stimulated Maximum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202100
UMLS CUI [1,2]
C1948023
UMLS CUI [1,3]
C0806909
currently self monitoring blood glucose levels (i.e. daily)
Beschreibung

Blood Glucose Self-Monitoring Daily

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0332173
no episodes of severe hypoglycemia for 60 days prior to screening
Beschreibung

Hypoglycemia Severe Episode Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C0332197
body mass index within the range 25-40 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
patient cannot live alone during the treatment phase and up to 1 month in follow-up
Beschreibung

Therapeutic procedure Living Alone Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439044
UMLS CUI [1,3]
C1299582
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known of suspected history of significant liver, or other gi disease
Beschreibung

Liver disease | Gastrointestinal Disease | Liver disease Suspected | Gastrointestinal Disease Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0017178
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0017178
UMLS CUI [4,2]
C0750491
history of significant cardiovascular disease including stroke, peripheral vascular disease or any related symptoms
Beschreibung

Cardiovascular Diseases | Cerebrovascular accident | Peripheral Vascular Diseases | Symptoms Related

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0085096
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0439849
history of peptic ulcer disease and/or gi bleeding/perforation
Beschreibung

Peptic Ulcer | Gastrointestinal Hemorrhage | Gastrointestinal perforation

Datentyp

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017181
UMLS CUI [3]
C0151664
history of cancer
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
history or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease
Beschreibung

Proliferative retinopathy | Severe nonproliferative diabetic retinopathy | Macular retinal edema | Diabetic oculopathy untreated

Datentyp

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2]
C0730278
UMLS CUI [3]
C0271051
UMLS CUI [4,1]
C0342245
UMLS CUI [4,2]
C0332155
history of treated peripheral or autonomic neuropathy
Beschreibung

Peripheral Neuropathy Treated | Autonomic neuropathy Treated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0259749
UMLS CUI [2,2]
C1522326
serum creatine superior or equal to 2.0 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
non-healed diabetic ulcer
Beschreibung

Diabetic ulcer Non-healed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0743150
UMLS CUI [1,2]
C0205301
history of hypoglycemic unawareness
Beschreibung

Loss of hypoglycemic warning

Datentyp

boolean

Alias
UMLS CUI [1]
C0342317
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Ähnliche Modelle

Eligibility Type 2 Diabetes NCT00239187

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained from participants
boolean
C0021430 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Treatment required for | Metformin | Thiazolidinediones | Healthy Volunteers
Item
clinical diagnosis type 2 diabetes requiring treatment with metformin and/or tzd and who are otherwise healthy
boolean
C0011860 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C1708335 (UMLS CUI [4])
Metformin | Thiazolidinediones | Regimen Stable
Item
on a stable metformin and/or tzd regimen for at least 60 days prior to screening
boolean
C0025598 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C0040808 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C-peptide level Stimulated Maximum
Item
maximum stimulated c-peptide level > 0.6 nmol/l (1.8 ng/ml)
boolean
C0202100 (UMLS CUI [1,1])
C1948023 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Blood Glucose Self-Monitoring Daily
Item
currently self monitoring blood glucose levels (i.e. daily)
boolean
C0005803 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
Hypoglycemia Severe Episode Absent
Item
no episodes of severe hypoglycemia for 60 days prior to screening
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Body mass index
Item
body mass index within the range 25-40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Therapeutic procedure Living Alone Unable
Item
patient cannot live alone during the treatment phase and up to 1 month in follow-up
boolean
C0087111 (UMLS CUI [1,1])
C0439044 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Liver disease | Gastrointestinal Disease | Liver disease Suspected | Gastrointestinal Disease Suspected
Item
known of suspected history of significant liver, or other gi disease
boolean
C0023895 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0023895 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0017178 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Cardiovascular Diseases | Cerebrovascular accident | Peripheral Vascular Diseases | Symptoms Related
Item
history of significant cardiovascular disease including stroke, peripheral vascular disease or any related symptoms
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0085096 (UMLS CUI [3])
C1457887 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
Peptic Ulcer | Gastrointestinal Hemorrhage | Gastrointestinal perforation
Item
history of peptic ulcer disease and/or gi bleeding/perforation
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0151664 (UMLS CUI [3])
Malignant Neoplasms
Item
history of cancer
boolean
C0006826 (UMLS CUI [1])
Proliferative retinopathy | Severe nonproliferative diabetic retinopathy | Macular retinal edema | Diabetic oculopathy untreated
Item
history or presence of proliferative retinopathy, severe non-proliferative retinopathy, macular edema or presence of untreated diabetic eye disease
boolean
C0339467 (UMLS CUI [1])
C0730278 (UMLS CUI [2])
C0271051 (UMLS CUI [3])
C0342245 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
Peripheral Neuropathy Treated | Autonomic neuropathy Treated
Item
history of treated peripheral or autonomic neuropathy
boolean
C0031117 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0259749 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
serum creatine superior or equal to 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Diabetic ulcer Non-healed
Item
non-healed diabetic ulcer
boolean
C0743150 (UMLS CUI [1,1])
C0205301 (UMLS CUI [1,2])
Loss of hypoglycemic warning
Item
history of hypoglycemic unawareness
boolean
C0342317 (UMLS CUI [1])
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