ID

37325

Description

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

Keywords

Versions (1)
  1. 7/17/19 7/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02200991

English

Eligibility Type 2 Diabetes Mellitus NCT02200991

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

boolean

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

Age

Data type

boolean

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

Hemoglobin A1c measurement

Data type

boolean

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

Plasma fasting glucose measurement

Data type

boolean

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

Lantus Stable status

Data type

boolean

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

Sulfonylurea Dose Stable

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Hypersensitivity Lixisenatide

Data type

boolean

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

Blood Glucose Uncontrolled Severe

Data type

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
Description

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

Data type

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
Description

Metabolic acidosis | Diabetic Ketoacidosis

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Kidney Failure, Chronic | Dialysis | Gastrointestinal Diseases

Data type

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
Description

Study Subject Participation Status | Considerations Additional

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02200991

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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