ID

32750

Beskrivning

Sitagliptin in Combination With Metformin and Sulfonylurea; ODM derived from: https://clinicaltrials.gov/show/NCT00686634

Länk

https://clinicaltrials.gov/show/NCT00686634

Nyckelord

Versioner (1)
  1. 2018-11-14 2018-11-14 -
Rättsinnehavare

See clinicaltrials.gov

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14 november 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00686634

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00686634

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
at least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (hemoglobin a1c (hba1c) >7.0%)
Beskrivning

Metformin Maximum Tolerated Dose | Sulfonylureas Maximum Tolerated Dose | Poor glycemic control | Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0752079
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0752079
UMLS CUI [3]
C0342299
UMLS CUI [4]
C0474680
able to comply with all scheduled visits and requirements of the protocol
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindications to the use of metformin or a sulfonylurea agent
Beskrivning

Medical contraindication Metformin | Medical contraindication Sulfonylurea

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0038766
extreme hyperglycemia or symptoms of polyuria or polydipsia
Beskrivning

Hyperglycemia Extreme | Symptoms Polyuria | Symptoms Polydipsia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205403
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0032617
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0085602
current or previous chronic use of insulin (other than for treatment of gestational diabetes)
Beskrivning

Insulin | Insulin chronic | Exception Therapy Gestational Diabetes

Datatyp

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0085207
history of confirmed (or clinical suspicion of) type 1 diabetes mellitus
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C0011854
episodes of symptomatic hypoglycemia averaging greater than once per day
Beskrivning

Episode of HYPOGLYCEMIA SYMPTOMATIC times/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0745152
UMLS CUI [1,3]
C0439511
estimated glomerular filtration rate (egfr) < 60 ml/min
Beskrivning

Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
subjects with active hemolytic anemias or hemoglobin variants that render the measurement of hba1c unreliable
Beskrivning

Anemia, Hemolytic | Hemoglobin variant result | Hemoglobin A1c measurement unreliable

Datatyp

boolean

Alias
UMLS CUI [1]
C0002878
UMLS CUI [2]
C1287255
UMLS CUI [3,1]
C0474680
UMLS CUI [3,2]
C0749770
history of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.
Beskrivning

Liver disease | Cardiovascular Disease | Digoxin | Systemic disease Major | Use of Sitagliptin At risk | Interpretation Research data Difficult

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0012265
UMLS CUI [4,1]
C0442893
UMLS CUI [4,2]
C0205164
UMLS CUI [5,1]
C1524063
UMLS CUI [5,2]
C1565750
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C0459471
UMLS CUI [6,2]
C0681873
UMLS CUI [6,3]
C0332218
female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
Beskrivning

Childbearing Potential Sexually active Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C0332197
current pregnancy or lactation.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.
Beskrivning

Pharmacotherapy Interferes with Glucose metabolism

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
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
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
Beskrivning

Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling | Barriers to treatment | Implementation Study Protocol Difficult

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C0558080
UMLS CUI [5]
C0679881
UMLS CUI [6,1]
C1708476
UMLS CUI [6,2]
C2348563
UMLS CUI [6,3]
C0332218
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00686634

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, age 18-75
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Metformin Maximum Tolerated Dose | Sulfonylureas Maximum Tolerated Dose | Poor glycemic control | Hemoglobin A1c measurement
Item
at least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (hemoglobin a1c (hba1c) >7.0%)
boolean
C0025598 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C0038766 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0342299 (UMLS CUI [3])
C0474680 (UMLS CUI [4])
Protocol Compliance
Item
able to comply with all scheduled visits and requirements of the protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Metformin | Medical contraindication Sulfonylurea
Item
any contraindications to the use of metformin or a sulfonylurea agent
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
Hyperglycemia Extreme | Symptoms Polyuria | Symptoms Polydipsia
Item
extreme hyperglycemia or symptoms of polyuria or polydipsia
boolean
C0020456 (UMLS CUI [1,1])
C0205403 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0032617 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0085602 (UMLS CUI [3,2])
Insulin | Insulin chronic | Exception Therapy Gestational Diabetes
Item
current or previous chronic use of insulin (other than for treatment of gestational diabetes)
boolean
C0021641 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0085207 (UMLS CUI [3,3])
Diabetes Mellitus, Insulin-Dependent | Suspicion Clinical Insulin-Dependent Diabetes Mellitus
Item
history of confirmed (or clinical suspicion of) type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0011854 (UMLS CUI [2,3])
Episode of HYPOGLYCEMIA SYMPTOMATIC times/day
Item
episodes of symptomatic hypoglycemia averaging greater than once per day
boolean
C0332189 (UMLS CUI [1,1])
C0745152 (UMLS CUI [1,2])
C0439511 (UMLS CUI [1,3])
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate (egfr) < 60 ml/min
boolean
C3811844 (UMLS CUI [1])
Anemia, Hemolytic | Hemoglobin variant result | Hemoglobin A1c measurement unreliable
Item
subjects with active hemolytic anemias or hemoglobin variants that render the measurement of hba1c unreliable
boolean
C0002878 (UMLS CUI [1])
C1287255 (UMLS CUI [2])
C0474680 (UMLS CUI [3,1])
C0749770 (UMLS CUI [3,2])
Liver disease | Cardiovascular Disease | Digoxin | Systemic disease Major | Use of Sitagliptin At risk | Interpretation Research data Difficult
Item
history of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.
boolean
C0023895 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0012265 (UMLS CUI [3])
C0442893 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C1524063 (UMLS CUI [5,1])
C1565750 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0459471 (UMLS CUI [6,1])
C0681873 (UMLS CUI [6,2])
C0332218 (UMLS CUI [6,3])
Childbearing Potential Sexually active Contraceptive methods Absent
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])
C0700589 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
current pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmacotherapy Interferes with Glucose metabolism
Item
subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.
boolean
C0013216 (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])
Informed Consent Unable | Informed Consent Unwilling | Protocol Compliance Unable | Protocol Compliance Unwilling | Barriers to treatment | Implementation Study Protocol Difficult
Item
subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0679881 (UMLS CUI [5])
C1708476 (UMLS CUI [6,1])
C2348563 (UMLS CUI [6,2])
C0332218 (UMLS CUI [6,3])
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