ID

29225

Beschreibung

A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide; ODM derived from: https://clinicaltrials.gov/show/NCT00696657

Link

https://clinicaltrials.gov/show/NCT00696657

Stichworte

Versionen (1)
  1. 09.03.18 09.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. März 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT00696657

Englisch

Eligibility Diabetes NCT00696657

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00696657
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
Beschreibung

Gender | Childbearing Potential Absent | Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C0872146
stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
Beschreibung

Metformin Dose Stable | Diet therapy | Exercise

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
hba1c: 7.0-10.0 % (both inclusive)
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
body weight between 60 kg and 110 kg
Beschreibung

Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with insulin, glp-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, alpha-gis, or any investigational drug, within the last three months
Beschreibung

Insulin | GLP-1 Receptor Agonist | liraglutide | Dipeptidyl Peptidase 4 Inhibitors | Sulfonylurea | Thiazolidinediones | alpha-Glucosidase Inhibitors | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C2917359
UMLS CUI [3]
C1456408
UMLS CUI [4]
C2917254
UMLS CUI [5]
C0038766
UMLS CUI [6]
C1257987
UMLS CUI [7]
C1299007
UMLS CUI [8]
C0013230
impaired liver or kidney function
Beschreibung

Liver Dysfunction | Renal Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
proliferative retinopathy or maculopathy requiring acute treatment
Beschreibung

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
Beschreibung

Cardiovascular Disease | Uncontrolled hypertension Treated | Uncontrolled hypertension untreated

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C1868885
UMLS CUI [3,2]
C0332155
recurrent major hypoglycaemia or hypoglycaemic unawareness
Beschreibung

Recurrent severe hypoglycemia | Loss of hypoglycemic warning

Datentyp

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)
Beschreibung

Pharmaceutical Preparations Interfere with Glucose level | CORTICOSTEROIDS FOR SYSTEMIC USE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0428548
UMLS CUI [2]
C3653708
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Ähnliche Modelle

Eligibility Diabetes NCT00696657

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00696657
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Childbearing Potential Absent | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
Metformin Dose Stable | Diet therapy | Exercise
Item
stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
Glucohemoglobin measurement
Item
hba1c: 7.0-10.0 % (both inclusive)
boolean
C0202054 (UMLS CUI [1])
Body Weight
Item
body weight between 60 kg and 110 kg
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin | GLP-1 Receptor Agonist | liraglutide | Dipeptidyl Peptidase 4 Inhibitors | Sulfonylurea | Thiazolidinediones | alpha-Glucosidase Inhibitors | Investigational New Drugs
Item
treatment with insulin, glp-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, alpha-gis, or any investigational drug, within the last three months
boolean
C0021641 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
C2917254 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C1257987 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Liver Dysfunction | Renal Insufficiency
Item
impaired liver or kidney function
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Cardiovascular Disease | Uncontrolled hypertension Treated | Uncontrolled hypertension untreated
Item
clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
boolean
C0007222 (UMLS CUI [1])
C1868885 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C1868885 (UMLS CUI [3,1])
C0332155 (UMLS CUI [3,2])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent major hypoglycaemia or hypoglycaemic unawareness
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Pharmaceutical Preparations Interfere with Glucose level | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0428548 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2])
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