ID

24045

Beschreibung

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1); ODM derived from: https://clinicaltrials.gov/show/NCT00509236

Link

https://clinicaltrials.gov/show/NCT00509236

Stichworte

Versionen (1)
  1. 23.07.17 23.07.17 -
Hochgeladen am

23. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00509236

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00509236

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has t2dm.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
participant is on dialysis on day of signing informed consent.
Beschreibung

Dialysis | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2]
C0021430
participant is unlikely to conceive or uses acceptable methods of birth control: hormonal contraceptive, intrauterine device (iud), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
Beschreibung

Pregnancy Unlikely | Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Contraceptive Sponge | Condom | Vasectomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0750558
UMLS CUI [2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0042241
UMLS CUI [6]
C0087145
UMLS CUI [7]
C0183461
UMLS CUI [8]
C0677582
UMLS CUI [9]
C0042387
participant has hemoglobin a1c ≥7% and ≤9% measured at or within 2 weeks prior to visit 4/week -2.
Beschreibung

Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0019018
participant is ≥85% compliant with study medication during the single-blind placebo run-in (as determined by tablet/capsule count) and compliant with diet, exercise and other run-in treatments during the run-in period.
Beschreibung

Compliance behavior Percent Investigational New Drugs | Compliance behavior Diet | Compliance behavior Exercise | Compliance behavior Therapeutic procedure Run-in Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0012159
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C0015259
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C3274438
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
participant is losing weight in a weight loss program and is not in the maintenance phase (defined as <2 kg weight loss in 2 months), or intends to be involved in weight loss intervention outside that prescribed by the study.
Beschreibung

Losing weight Weight Reduction Program | Maintenance Phase Absent | Weight loss Intervention intended

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C3179079
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0205390
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1262477
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C1283828
participant has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
Beschreibung

Hematological Disease | Aplastic Anemia | myeloproliferative syndrome | MYELODYSPLASTIC SYNDROME | Thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0002874
UMLS CUI [3]
C1443043
UMLS CUI [4]
C3463824
UMLS CUI [5]
C0040034
participant has cirrhosis or active liver disease.
Beschreibung

Liver Cirrhosis | Liver diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0023895
participant has been on dialysis for < 6 months.
Beschreibung

Dialysis Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0449238
participant has been diagnosed with a significant cardiovascular disorder and has new or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent.
Beschreibung

Cardiovascular Disease | Congestive heart failure Sign or Symptom New | Congestive heart failure Sign or Symptom Worsening

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C3540840
UMLS CUI [2,3]
C0205314
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C3540840
UMLS CUI [3,3]
C0332271
participant has severe active peripheral vascular disease.
Beschreibung

Peripheral Vascular Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205082
participant has a history of malignancy ≤ 5 years prior to signing informed consent, or > 5 years without documentation of remission/cure.
Beschreibung

Malignant Neoplasms disease length | Remission Absent | Cure Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0687702
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1880198
UMLS CUI [3,2]
C0332197
participant is under treatment for hyperthyroidism.
Beschreibung

Therapeutic procedure Hyperthyroidism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0020550
participant has a hypersensitivity or contraindication to glipizide.
Beschreibung

Hypersensitivity Glipizide | Medical contraindication Glipizide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0017642
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0017642
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00509236

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
participant has t2dm.
boolean
C0011860 (UMLS CUI [1])
Dialysis | Informed Consent
Item
participant is on dialysis on day of signing informed consent.
boolean
C0011946 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Pregnancy Unlikely | Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Contraceptive Sponge | Condom | Vasectomy
Item
participant is unlikely to conceive or uses acceptable methods of birth control: hormonal contraceptive, intrauterine device (iud), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
boolean
C0032961 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
C2985296 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0042241 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C0183461 (UMLS CUI [7])
C0677582 (UMLS CUI [8])
C0042387 (UMLS CUI [9])
Glycosylated hemoglobin A
Item
participant has hemoglobin a1c ≥7% and ≤9% measured at or within 2 weeks prior to visit 4/week -2.
boolean
C0019018 (UMLS CUI [1])
Compliance behavior Percent Investigational New Drugs | Compliance behavior Diet | Compliance behavior Exercise | Compliance behavior Therapeutic procedure Run-in Period
Item
participant is ≥85% compliant with study medication during the single-blind placebo run-in (as determined by tablet/capsule count) and compliant with diet, exercise and other run-in treatments during the run-in period.
boolean
C1321605 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C0012159 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3,1])
C0015259 (UMLS CUI [3,2])
C1321605 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C3274438 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
Losing weight Weight Reduction Program | Maintenance Phase Absent | Weight loss Intervention intended
Item
participant is losing weight in a weight loss program and is not in the maintenance phase (defined as <2 kg weight loss in 2 months), or intends to be involved in weight loss intervention outside that prescribed by the study.
boolean
C1262477 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0024501 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1262477 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C1283828 (UMLS CUI [3,3])
Hematological Disease | Aplastic Anemia | myeloproliferative syndrome | MYELODYSPLASTIC SYNDROME | Thrombocytopenia
Item
participant has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
boolean
C0018939 (UMLS CUI [1])
C0002874 (UMLS CUI [2])
C1443043 (UMLS CUI [3])
C3463824 (UMLS CUI [4])
C0040034 (UMLS CUI [5])
Liver Cirrhosis | Liver diseases
Item
participant has cirrhosis or active liver disease.
boolean
C0023890 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Dialysis Duration
Item
participant has been on dialysis for < 6 months.
boolean
C0011946 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Cardiovascular Disease | Congestive heart failure Sign or Symptom New | Congestive heart failure Sign or Symptom Worsening
Item
participant has been diagnosed with a significant cardiovascular disorder and has new or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent.
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C3540840 (UMLS CUI [2,2])
C0205314 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3,1])
C3540840 (UMLS CUI [3,2])
C0332271 (UMLS CUI [3,3])
Peripheral Vascular Disease Severe
Item
participant has severe active peripheral vascular disease.
boolean
C0085096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Malignant Neoplasms disease length | Remission Absent | Cure Absent
Item
participant has a history of malignancy ≤ 5 years prior to signing informed consent, or > 5 years without documentation of remission/cure.
boolean
C0006826 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0687702 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1880198 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Therapeutic procedure Hyperthyroidism
Item
participant is under treatment for hyperthyroidism.
boolean
C0087111 (UMLS CUI [1,1])
C0020550 (UMLS CUI [1,2])
Hypersensitivity Glipizide | Medical contraindication Glipizide
Item
participant has a hypersensitivity or contraindication to glipizide.
boolean
C0020517 (UMLS CUI [1,1])
C0017642 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0017642 (UMLS CUI [2,2])
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