ID

19398

Description

Insulin Glargine Versus Twice-Daily NPH; ODM derived from: https://clinicaltrials.gov/show/NCT00687453

Lien

https://clinicaltrials.gov/show/NCT00687453

Mots-clés

Versions (1)
  1. 29/12/2016 29/12/2016 -
Téléchargé le

29 décembre 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00687453

Anglais

Eligibility Type 2 Diabetes Mellitus NCT00687453

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age 18-75
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes diagnosed for at least 1 year
Description

Non-Insulin-Dependent Diabetes Mellitus disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
inadequate glycemic control (hemoglobin a1c ≥ 7.5%) on stable and maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime injection of nph insulin
Description

Poor glycemic control | Glucohemoglobin measurement | Sulfonylurea Maximum Tolerated Dose Stable | Metformin Maximum Tolerated Dose Stable | Thiazolidinedione Maximum Tolerated Dose Stable | NPH insulin Injection Bedtime Single

Type de données

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2]
C0202054
UMLS CUI [3,1]
C0038766
UMLS CUI [3,2]
C0752079
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0752079
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C1257987
UMLS CUI [5,2]
C0752079
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C0021658
UMLS CUI [6,2]
C1828121
UMLS CUI [6,3]
C0521112
UMLS CUI [6,4]
C0205171
except for the subject's current bedtime nph insulin, no other past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
Description

NPH insulin Bedtime | Insulin use chronic | Therapeutic procedure Gestational Diabetes | hospitalization length of stay

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021658
UMLS CUI [1,2]
C0521112
UMLS CUI [2,1]
C0240016
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0085207
UMLS CUI [4]
C3694481
average fasting plasma glucose level <130 mg/dl without fasting hypoglycemia
Description

Plasma fasting glucose measurement Average | Fasting Hypoglycemia Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0583513
UMLS CUI [1,2]
C1510992
UMLS CUI [2,1]
C0271708
UMLS CUI [2,2]
C0332268
hemoglobin a1c between 7.5% and 12%
Description

Glucohemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0202054
body mass index (bmi) between 20 and 40 kg/m2
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of confirmed (or clinical suspicion of ) type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent | Insulin-Dependent Diabetes Mellitus Suspicion Clinical

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C0242114
UMLS CUI [2,3]
C0205210
female subjects of childbearing potential who are sexually active and not using a reliable form of contraception.
Description

Childbearing Potential Sexually active | Childbearing Potential Contraceptive methods Inadequate

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0205412
current pregnancy or lactation.
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects for whom intensive insulin therapy is contraindicated
Description

Medical contraindication Insulin regime intense

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0557978
UMLS CUI [1,3]
C0522510
subjects with advanced proliferative diabetic retinopathy
Description

Proliferative diabetic retinopathy Advanced

Type de données

boolean

Alias
UMLS CUI [1,1]
C0154830
UMLS CUI [1,2]
C0205179
subjects who are unable to stay on a consistent daily meal schedule
Description

Meal Daily Consistent | Meal Plan Unable

Type de données

boolean

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C0332290
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C1299582
history of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.
Description

Kidney Disease Clinical Significance | Liver disease | Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease Major Clinical Significance | Implementation Study Protocol Difficult | Interpretation Data Difficult

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0014130
UMLS CUI [6,1]
C0442893
UMLS CUI [6,2]
C0205164
UMLS CUI [6,3]
C2826293
UMLS CUI [7,1]
C1708476
UMLS CUI [7,2]
C2348563
UMLS CUI [7,3]
C0332218
UMLS CUI [8,1]
C0459471
UMLS CUI [8,2]
C1511726
UMLS CUI [8,3]
C0332218
subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study
Description

Pharmaceutical Preparations Interferes with Glucose metabolism

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
Description

Study Subject Participation Status | Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.
Description

Protocol Compliance Unable | Protocol Compliance Unwilling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00687453

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, age 18-75
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes diagnosed for at least 1 year
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Poor glycemic control | Glucohemoglobin measurement | Sulfonylurea Maximum Tolerated Dose Stable | Metformin Maximum Tolerated Dose Stable | Thiazolidinedione Maximum Tolerated Dose Stable | NPH insulin Injection Bedtime Single
Item
inadequate glycemic control (hemoglobin a1c ≥ 7.5%) on stable and maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione, plus a single bedtime injection of nph insulin
boolean
C0342299 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
C0038766 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0025598 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C1257987 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0021658 (UMLS CUI [6,1])
C1828121 (UMLS CUI [6,2])
C0521112 (UMLS CUI [6,3])
C0205171 (UMLS CUI [6,4])
NPH insulin Bedtime | Insulin use chronic | Therapeutic procedure Gestational Diabetes | hospitalization length of stay
Item
except for the subject's current bedtime nph insulin, no other past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
boolean
C0021658 (UMLS CUI [1,1])
C0521112 (UMLS CUI [1,2])
C0240016 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0085207 (UMLS CUI [3,2])
C3694481 (UMLS CUI [4])
Plasma fasting glucose measurement Average | Fasting Hypoglycemia Lacking
Item
average fasting plasma glucose level <130 mg/dl without fasting hypoglycemia
boolean
C0583513 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C0271708 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Glucohemoglobin measurement
Item
hemoglobin a1c between 7.5% and 12%
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 20 and 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Insulin-Dependent Diabetes Mellitus Suspicion Clinical
Item
history of confirmed (or clinical suspicion of ) type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0242114 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Childbearing Potential Sexually active | Childbearing Potential Contraceptive methods Inadequate
Item
female subjects of childbearing potential who are sexually active and not using a reliable form of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
current pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication Insulin regime intense
Item
subjects for whom intensive insulin therapy is contraindicated
boolean
C1301624 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
Proliferative diabetic retinopathy Advanced
Item
subjects with advanced proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Meal Daily Consistent | Meal Plan Unable
Item
subjects who are unable to stay on a consistent daily meal schedule
boolean
C1998602 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C1998602 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Kidney Disease Clinical Significance | Liver disease | Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease Major Clinical Significance | Implementation Study Protocol Difficult | Interpretation Data Difficult
Item
history of any clinically significant renal, hepatic, cardiovascular, neurological, endocrinological or other major systemic disease that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the data difficult.
boolean
C0022658 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0442893 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C2826293 (UMLS CUI [6,3])
C1708476 (UMLS CUI [7,1])
C2348563 (UMLS CUI [7,2])
C0332218 (UMLS CUI [7,3])
C0459471 (UMLS CUI [8,1])
C1511726 (UMLS CUI [8,2])
C0332218 (UMLS CUI [8,3])
Pharmaceutical Preparations Interferes with Glucose metabolism
Item
subjects who will likely require or initiate therapy with drugs which may interfere with glucose metabolism during the course of the study
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
subjects who are unable or unwilling to comply with all components of the study protocol, including contacting the investigators at specified times and attending all scheduled follow-up visits.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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