ID

19397

Beschreibung

Insulin Glargine at Bedtime or in AM Versus NPH; ODM derived from: https://clinicaltrials.gov/show/NCT00686712

Link

https://clinicaltrials.gov/show/NCT00686712

Stichworte

Versionen (1)
  1. 29.12.16 29.12.16 -
Hochgeladen am

29. Dezember 2016

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00686712

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00686712

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Non-Insulin-Dependent Diabetes Mellitus disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treatment with stable doses of oral agents (alone or in combination) for at least 2 months
Beschreibung

Oral medication Dosage Stable | Pharmaceutical Preparation Single | Pharmaceutical Preparations Combined

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205171
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0205195
inadequate glycemic control (hemoglobin a1c ≥ 7.5%) on maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione
Beschreibung

Poor glycemic control | Glucohemoglobin measurement | Sulfonylurea Maximum Tolerated Dose | Metformin Maximum Tolerated Dose | Thiazolidinedione Maximum Tolerated Dose

Datentyp

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2]
C0202054
UMLS CUI [3,1]
C0038766
UMLS CUI [3,2]
C0752079
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0752079
UMLS CUI [5,1]
C1257987
UMLS CUI [5,2]
C0752079
no past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0240016
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0085207
UMLS CUI [3]
C3694481
hemoglobin a1c between 7.5% and 12%
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

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

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
current or previous chronic use of insulin (other than for treatment of gestational diabetes)
Beschreibung

Insulin use chronic | Therapeutic procedure Gestational Diabetes

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0240016
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0085207
history of confirmed (or clinical suspicion of) type 1 diabetes
Beschreibung

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

Datentyp

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
Beschreibung

Childbearing Potential Sexually active | Childbearing Potential Contraceptive methods Inadequate

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects for whom insulin therapy is contraindicated or for whom, in the opinion of the investigator, therapy with insulin is not indicated
Beschreibung

Medical contraindication Insulin regime | Insulin regime Indication Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0557978
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C3146298
UMLS CUI [2,3]
C0332268
subjects with advanced proliferative diabetic retinopathy
Beschreibung

Proliferative diabetic retinopathy Advanced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0154830
UMLS CUI [1,2]
C0205179
subjects who work night shifts or who are unable to stay on a consistent daily meal schedule
Beschreibung

Night shift worker | Meal Daily Consistent | Meal Plan Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0555008
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C0332173
UMLS CUI [2,3]
C0332290
UMLS CUI [3,1]
C1998602
UMLS CUI [3,2]
C1301732
UMLS CUI [3,3]
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.
Beschreibung

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

Datentyp

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
Beschreibung

Pharmaceutical Preparations Interferes with Glucose metabolism

Datentyp

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
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

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.
Beschreibung

Protocol Compliance Unable | Protocol Compliance Unwilling

Datentyp

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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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00686712

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Oral medication Dosage Stable | Pharmaceutical Preparation Single | Pharmaceutical Preparations Combined
Item
treatment with stable doses of oral agents (alone or in combination) for at least 2 months
boolean
C0175795 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0205195 (UMLS CUI [3,2])
Poor glycemic control | Glucohemoglobin measurement | Sulfonylurea Maximum Tolerated Dose | Metformin Maximum Tolerated Dose | Thiazolidinedione Maximum Tolerated Dose
Item
inadequate glycemic control (hemoglobin a1c ≥ 7.5%) on maximum-tolerated doses of a sulfonylurea, metformin and a thiazolidinedione
boolean
C0342299 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
C0038766 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C1257987 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
Insulin use chronic | Therapeutic procedure Gestational Diabetes | hospitalization length of stay
Item
no past history of chronic insulin use (other than treatment of gestational diabetes or hospitalizations of less than 1 week in duration)
boolean
C0240016 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
C3694481 (UMLS CUI [3])
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)
Insulin use chronic | Therapeutic procedure Gestational Diabetes
Item
current or previous chronic use of insulin (other than for treatment of gestational diabetes)
boolean
C0240016 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0085207 (UMLS CUI [2,2])
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 | Insulin regime Indication Lacking
Item
subjects for whom insulin therapy is contraindicated or for whom, in the opinion of the investigator, therapy with insulin is not indicated
boolean
C1301624 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C3146298 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Proliferative diabetic retinopathy Advanced
Item
subjects with advanced proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Night shift worker | Meal Daily Consistent | Meal Plan Unable
Item
subjects who work night shifts or who are unable to stay on a consistent daily meal schedule
boolean
C0555008 (UMLS CUI [1])
C1998602 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C1998602 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
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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