ID

37325

Beschrijving

Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine; ODM derived from: https://clinicaltrials.gov/show/NCT02200991

Link

https://clinicaltrials.gov/show/NCT02200991

Trefwoorden

Versies (1)
  1. 17-07-19 17-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 juli 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Type 2 Diabetes Mellitus NCT02200991

Engels

Eligibility Type 2 Diabetes Mellitus NCT02200991

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus, treated with lantus±su; ≥5-year after diagnosis
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length | Lantus | Sulfonylurea

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0876064
UMLS CUI [3]
C3536898
aged 20-75 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
hemoglobin a1c ≥7.0%-≤10.0%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
fasting plasma glucose ≤180 mg/dl at screening
Beschrijving

Plasma fasting glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0583513
stable treatment (±20%) with lantus for 3 months or more prior to screening.
Beschrijving

Lantus Stable status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0876064
UMLS CUI [1,2]
C0205360
sulfonylurea dose stable for 3 months or more prior to screening
Beschrijving

Sulfonylurea Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3536898
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
pregnancy or lactation
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hypersensitivity to lixisenatide
Beschrijving

Hypersensitivity Lixisenatide

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2973895
severely uncontrolled glycemic situation
Beschrijving

Blood Glucose Uncontrolled Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005802
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205082
history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease
Beschrijving

Pancreatitis Unexplained | Pancreatitis, Chronic | Pancreatectomy | Operation on stomach | Inflammatory Bowel Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030305
UMLS CUI [1,2]
C4288071
UMLS CUI [2]
C0149521
UMLS CUI [3]
C0030279
UMLS CUI [4]
C0192398
UMLS CUI [5]
C0021390
history of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening
Beschrijving

Metabolic acidosis | Diabetic Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0011880
history within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse
Beschrijving

Myocardial Infarction | Cerebrovascular accident | Heart failure Requirement Hospitalization | Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0019993
UMLS CUI [4]
C0038586
uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure >180 mmhg or diastolic blood pressure >95 mmhg
Beschrijving

Uncontrolled hypertension | Poor hypertension control | Systolic blood pressure at rest | Diastolic blood pressure at rest

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0421190
UMLS CUI [3]
C2039694
UMLS CUI [4]
C2183311
amylase and/or lipase >3 times or aspartate aminotransferase (ast), alanine aminotransferase (alt) or alkaline phosphatase (alp) >2 times the upper limit of the normal laboratory range
Beschrijving

Serum amylase raised | Serum lipase raised | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum alkaline phosphatase raised

Datatype

boolean

Alias
UMLS CUI [1]
C0476327
UMLS CUI [2]
C3670924
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C1314665
end-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease
Beschrijving

Kidney Failure, Chronic | Dialysis | Gastrointestinal Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0011946
UMLS CUI [3]
C0017178
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Beschrijving

Study Subject Participation Status | Considerations Additional

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
Terug naar het begin van de pagina

Similar models

Eligibility Type 2 Diabetes Mellitus NCT02200991

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length | Lantus | Sulfonylurea
Item
type 2 diabetes mellitus, treated with lantus±su; ≥5-year after diagnosis
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0876064 (UMLS CUI [2])
C3536898 (UMLS CUI [3])
Age
Item
aged 20-75 years
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hemoglobin a1c ≥7.0%-≤10.0%
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose ≤180 mg/dl at screening
boolean
C0583513 (UMLS CUI [1])
Lantus Stable status
Item
stable treatment (±20%) with lantus for 3 months or more prior to screening.
boolean
C0876064 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Sulfonylurea Dose Stable
Item
sulfonylurea dose stable for 3 months or more prior to screening
boolean
C3536898 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Lixisenatide
Item
hypersensitivity to lixisenatide
boolean
C0020517 (UMLS CUI [1,1])
C2973895 (UMLS CUI [1,2])
Blood Glucose Uncontrolled Severe
Item
severely uncontrolled glycemic situation
boolean
C0005802 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Pancreatitis Unexplained | Pancreatitis, Chronic | Pancreatectomy | Operation on stomach | Inflammatory Bowel Disease
Item
history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease
boolean
C0030305 (UMLS CUI [1,1])
C4288071 (UMLS CUI [1,2])
C0149521 (UMLS CUI [2])
C0030279 (UMLS CUI [3])
C0192398 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
Metabolic acidosis | Diabetic Ketoacidosis
Item
history of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening
boolean
C0220981 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
Myocardial Infarction | Cerebrovascular accident | Heart failure Requirement Hospitalization | Substance Use Disorders
Item
history within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0019993 (UMLS CUI [3,3])
C0038586 (UMLS CUI [4])
Uncontrolled hypertension | Poor hypertension control | Systolic blood pressure at rest | Diastolic blood pressure at rest
Item
uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure >180 mmhg or diastolic blood pressure >95 mmhg
boolean
C1868885 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
C2039694 (UMLS CUI [3])
C2183311 (UMLS CUI [4])
Serum amylase raised | Serum lipase raised | Aspartate aminotransferase increased | Alanine aminotransferase increased | Serum alkaline phosphatase raised
Item
amylase and/or lipase >3 times or aspartate aminotransferase (ast), alanine aminotransferase (alt) or alkaline phosphatase (alp) >2 times the upper limit of the normal laboratory range
boolean
C0476327 (UMLS CUI [1])
C3670924 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C1314665 (UMLS CUI [5])
Kidney Failure, Chronic | Dialysis | Gastrointestinal Diseases
Item
end-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease
boolean
C0022661 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0017178 (UMLS CUI [3])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial