ID

20667

Beschreibung

Insulin Glargine in Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00347100

Link

https://clinicaltrials.gov/show/NCT00347100

Stichworte

Versionen (2)
  1. 09.03.17 09.03.17 -
  2. 09.03.17 09.03.17 -
Hochgeladen am

9. März 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Diabetes Mellitus, Type 2 NCT00347100

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00347100

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes patients with first oad (sulfonylurea [su] or metformin) failure
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral failed | Sulfonylurea | Metformin

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0038766
UMLS CUI [4]
C0025598
patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
Beschreibung

Insulin naive | Insulin Gestational Diabetes | Insulin regime Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0085207
UMLS CUI [3,1]
C0557978
UMLS CUI [3,2]
C0449238
serum creatinine ≤ 1.5mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
bmi: 21-41 kg/m²
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
7.5%< a1c <11%
Beschreibung

Glycosylated hemoglobin A Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
fasting plasma glucose > 7.5mmol/l
Beschreibung

Plasma fasting glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
on diet and exercise therapy and stable oad treatment (su or metformin > ½ maximal dose)for more than 1 month prior to enrolment
Beschreibung

Diet therapy | Exercise Therapeutic procedure | Antidiabetics Oral Stable | Sulfonylurea | Metformin

Datentyp

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0087111
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0205360
UMLS CUI [4]
C0038766
UMLS CUI [5]
C0025598
women not of childbearing potential (sterilization procedure done or menopausal > 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
Beschreibung

Female Sterilization | Menopausal Duration | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2,1]
C0025320
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
able and willing to monitor blood glucose
Beschreibung

Monitor blood glucose Able | Monitor blood glucose Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1820407
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C1820407
UMLS CUI [2,2]
C0600109
able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
Beschreibung

Blood Glucose Self-Monitoring Able | Blood Glucose Self-Monitoring Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0005803
UMLS CUI [2,2]
C0600109
understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin
Beschreibung

Insulin regime Possible | Insulin injection Self Willing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0332149
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C0036588
UMLS CUI [2,3]
C0600109
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
Beschreibung

Complications of Diabetes Mellitus | Diabetic Ketoacidosis | Hyperosmolar Coma

Datentyp

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0011880
UMLS CUI [3]
C0020457
pregnancy, breast-feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
people who work night shifts
Beschreibung

Night shift worker

Datentyp

boolean

Alias
UMLS CUI [1]
C0555008
hypersensitivity to investigational drugs or its additives, or intolerability to metformin
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs additive | intolerance to Metformin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0301283
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0025598
need for use of medications prohibited by the protocol during the study for treatment purpose
Beschreibung

Illicit drug use Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0686904
significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
Beschreibung

Disease Protocol Compliance Unable | Disease Difficulty with study analysis | Cardiovascular Disease | Liver disease | nervous system disorder | Endocrine System Disease | Body system Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332218
UMLS CUI [2,3]
C0681874
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0014130
UMLS CUI [7,1]
C0460002
UMLS CUI [7,2]
C0012634
drugs or alcohol abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00347100

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral failed | Sulfonylurea | Metformin
Item
type 2 diabetes patients with first oad (sulfonylurea [su] or metformin) failure
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0038766 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
Insulin naive | Insulin Gestational Diabetes | Insulin regime Duration
Item
patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
C0557978 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5mg/dl
boolean
C0201976 (UMLS CUI [1])
Body mass index
Item
bmi: 21-41 kg/m²
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
7.5%< a1c <11%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose > 7.5mmol/l
boolean
C0583513 (UMLS CUI [1])
Diet therapy | Exercise Therapeutic procedure | Antidiabetics Oral Stable | Sulfonylurea | Metformin
Item
on diet and exercise therapy and stable oad treatment (su or metformin > ½ maximal dose)for more than 1 month prior to enrolment
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0038766 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
Female Sterilization | Menopausal Duration | Childbearing Potential Contraceptive methods
Item
women not of childbearing potential (sterilization procedure done or menopausal > 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
boolean
C0015787 (UMLS CUI [1])
C0025320 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Monitor blood glucose Able | Monitor blood glucose Willing
Item
able and willing to monitor blood glucose
boolean
C1820407 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C1820407 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Blood Glucose Self-Monitoring Able | Blood Glucose Self-Monitoring Willing
Item
able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
boolean
C0005803 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Insulin regime Possible | Insulin injection Self Willing
Item
understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin
boolean
C0557978 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C0199782 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Complications of Diabetes Mellitus | Diabetic Ketoacidosis | Hyperosmolar Coma
Item
acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
boolean
C0342257 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C0020457 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnancy, breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Night shift worker
Item
people who work night shifts
boolean
C0555008 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs additive | intolerance to Metformin
Item
hypersensitivity to investigational drugs or its additives, or intolerability to metformin
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0301283 (UMLS CUI [2,3])
C1744706 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
Illicit drug use Patient need for
Item
need for use of medications prohibited by the protocol during the study for treatment purpose
boolean
C0281875 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Disease Protocol Compliance Unable | Disease Difficulty with study analysis | Cardiovascular Disease | Liver disease | nervous system disorder | Endocrine System Disease | Body system Disease
Item
significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
boolean
C0012634 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0332218 (UMLS CUI [2,2])
C0681874 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0460002 (UMLS CUI [7,1])
C0012634 (UMLS CUI [7,2])
Substance Use Disorders
Item
drugs or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status
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])
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