ID

37353

Descrição

Linagliptin Inpatient Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02004366

Link

https://clinicaltrials.gov/show/NCT02004366

Palavras-chave

Versões (1)
  1. 20/07/2019 20/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de julho de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02004366

Inglês

Eligibility Type 2 Diabetes NCT02004366

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males or female surgical non-icu patients ages between18 and 80 years
Descrição

Age | Clinic Visits Absent Surgical intensive care unit

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0008952
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1690590
2. a known history of t2d > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding dpp-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
Descrição

Non-Insulin-Dependent Diabetes Mellitus Disease length | Diet therapy | Antidiabetics Oral | Sulfonylureas | Metformin | Combined Modality Therapy | Exception Dipeptidyl-Peptidase IV Inhibitors | Insulin regime Low dose

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0012159
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4]
C0038766
UMLS CUI [5]
C0025598
UMLS CUI [6]
C0009429
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1827106
UMLS CUI [8,1]
C0557978
UMLS CUI [8,2]
C0445550
3. subjects with a bg >140 mg and < 400 mg/dl at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 meq/l or positive serum or urinary ketones)
Descrição

Blood glucose measurement | Diabetic Ketoacidosis Absent | Serum bicarbonate measurement | Serum ketones Positive | Urine ketone test Positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392201
UMLS CUI [2,1]
C0011880
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0428301
UMLS CUI [4,1]
C0036812
UMLS CUI [4,2]
C1514241
UMLS CUI [5,1]
C0555179
UMLS CUI [5,2]
C1514241
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age < 18 or > 80 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. subjects with increased bg concentration, but without a history of diabetes (stress hyperglycemia).
Descrição

Blood glucose increased | Diabetes Mellitus Absent | Stress induced hyperglycaemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0595877
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0856953
3. subjects with a history of type 1 diabetes (suggested by bmi < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
Descrição

Diabetes Mellitus, Insulin-Dependent | Body mass index Requirement Insulin regime | Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State | Ketonuria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C1305855
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0557978
UMLS CUI [3]
C0011880
UMLS CUI [4]
C3888846
UMLS CUI [5]
C0162275
4. treatment with dipeptidyl peptidase-4 (dpp4) inhibitor or glucagon-like peptide-1 (glp1) analogs during the past 3 months prior to admission.
Descrição

Dipeptidyl-Peptidase IV Inhibitors | GLP-1 Analogue

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1827106
UMLS CUI [2]
C3273809
5. acute critical illness or coronary artery bypass graft (cabg) surgery expected to require admission to a critical care unit.
Descrição

Critical Illness | Coronary Artery Bypass Surgery | Admission Critical care unit Expected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0010340
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C0184666
UMLS CUI [3,2]
C0021708
UMLS CUI [3,3]
C1517001
6. subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
Descrição

Gastrointestinal obstruction | Adynamic Ileus | Suction gastrointestinal Expected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0236124
UMLS CUI [2]
C0030446
UMLS CUI [3,1]
C0038638
UMLS CUI [3,2]
C0521362
UMLS CUI [3,3]
C1517001
7. patients with clinically relevant pancreatic or gallbladder disease.
Descrição

Pancreatic Disease | Gall Bladder Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030286
UMLS CUI [2]
C0016977
8. patients with previous history of pancreatitis
Descrição

Pancreatitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030305
9. patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (gfr < 30 ml/min).
Descrição

Myocardial Infarction | Liver disease | Renal Insufficiency | Glomerular Filtration Rate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0023895
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0017654
10. chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
Descrição

Steroids chronic Total Daily Dose | Prednisone Equivalent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C2348070
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0205163
11. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Descrição

Mental impairment | Study Protocol Comprehension Unable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0683322
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C1299582
12. pregnancy or breast feeding at time of enrollment into the study.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. patients who received supplemental sliding scale insulin >72 hours prior to randomization
Descrição

Sliding scale insulin regime Supplemental

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0557977
UMLS CUI [1,2]
C2348609
14. patients who received basal insulin > 48 hours prior to randomization
Descrição

Basal insulin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0650607
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Similar models

Eligibility Type 2 Diabetes NCT02004366

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age | Clinic Visits Absent Surgical intensive care unit
Item
1. males or female surgical non-icu patients ages between18 and 80 years
boolean
C0001779 (UMLS CUI [1])
C0008952 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1690590 (UMLS CUI [2,3])
Non-Insulin-Dependent Diabetes Mellitus Disease length | Diet therapy | Antidiabetics Oral | Sulfonylureas | Metformin | Combined Modality Therapy | Exception Dipeptidyl-Peptidase IV Inhibitors | Insulin regime Low dose
Item
2. a known history of t2d > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding dpp-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0012159 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4])
C0025598 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C1827106 (UMLS CUI [7,2])
C0557978 (UMLS CUI [8,1])
C0445550 (UMLS CUI [8,2])
Blood glucose measurement | Diabetic Ketoacidosis Absent | Serum bicarbonate measurement | Serum ketones Positive | Urine ketone test Positive
Item
3. subjects with a bg >140 mg and < 400 mg/dl at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 meq/l or positive serum or urinary ketones)
boolean
C0392201 (UMLS CUI [1])
C0011880 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0428301 (UMLS CUI [3])
C0036812 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0555179 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age < 18 or > 80 years.
boolean
C0001779 (UMLS CUI [1])
Blood glucose increased | Diabetes Mellitus Absent | Stress induced hyperglycaemia
Item
2. subjects with increased bg concentration, but without a history of diabetes (stress hyperglycemia).
boolean
C0595877 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0856953 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Body mass index Requirement Insulin regime | Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State | Ketonuria
Item
3. subjects with a history of type 1 diabetes (suggested by bmi < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
boolean
C0011854 (UMLS CUI [1])
C1305855 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0557978 (UMLS CUI [2,3])
C0011880 (UMLS CUI [3])
C3888846 (UMLS CUI [4])
C0162275 (UMLS CUI [5])
Dipeptidyl-Peptidase IV Inhibitors | GLP-1 Analogue
Item
4. treatment with dipeptidyl peptidase-4 (dpp4) inhibitor or glucagon-like peptide-1 (glp1) analogs during the past 3 months prior to admission.
boolean
C1827106 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
Critical Illness | Coronary Artery Bypass Surgery | Admission Critical care unit Expected
Item
5. acute critical illness or coronary artery bypass graft (cabg) surgery expected to require admission to a critical care unit.
boolean
C0010340 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0184666 (UMLS CUI [3,1])
C0021708 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
Gastrointestinal obstruction | Adynamic Ileus | Suction gastrointestinal Expected
Item
6. subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
boolean
C0236124 (UMLS CUI [1])
C0030446 (UMLS CUI [2])
C0038638 (UMLS CUI [3,1])
C0521362 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
Pancreatic Disease | Gall Bladder Disease
Item
7. patients with clinically relevant pancreatic or gallbladder disease.
boolean
C0030286 (UMLS CUI [1])
C0016977 (UMLS CUI [2])
Pancreatitis
Item
8. patients with previous history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Myocardial Infarction | Liver disease | Renal Insufficiency | Glomerular Filtration Rate
Item
9. patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (gfr < 30 ml/min).
boolean
C0027051 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0017654 (UMLS CUI [4])
Steroids chronic Total Daily Dose | Prednisone Equivalent
Item
10. chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
boolean
C0038317 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Mental impairment | Study Protocol Comprehension Unable
Item
11. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
boolean
C0683322 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
12. pregnancy or breast feeding at time of enrollment into the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Sliding scale insulin regime Supplemental
Item
13. patients who received supplemental sliding scale insulin >72 hours prior to randomization
boolean
C0557977 (UMLS CUI [1,1])
C2348609 (UMLS CUI [1,2])
Basal insulin
Item
14. patients who received basal insulin > 48 hours prior to randomization
boolean
C0650607 (UMLS CUI [1])
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