ID

25533

Descripción

A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00467649

Link

https://clinicaltrials.gov/show/NCT00467649

Palabras clave

Versiones (1)
  1. 5/9/17 5/9/17 -
Subido en

5 de septiembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00467649

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00467649

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
has a clinical diagnosis of type 2 diabetes mellitus
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
has an hba1c >7.0% and ≤10.0%
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
has a bmi of ≥25 kg/m^2 and ≤50 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
has been on a regimen of insulin for less than 6 months and is taking less than 50 u total of insulin per day, or has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy
Descripción

Insulin regime | Insulin U/day | Insulin regime Pre-existing Absent | Patient Appropriate Initiation Basal insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0557978
UMLS CUI [3,2]
C2347662
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1548787
UMLS CUI [4,3]
C1704686
UMLS CUI [4,4]
C0650607
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months
Descripción

Recurrent severe hypoglycemia Treatment required for

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0342316
UMLS CUI [1,2]
C0332121
requires the use of drugs that stimulate gastrointestinal motility
Descripción

Requirement Pharmaceutical Preparations Stimulating Gastrointestinal Motility

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1948023
UMLS CUI [1,4]
C0017184
has been previously treated with symlin (or has participated in a symlin clinical study)
Descripción

Symlin | Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1174780
UMLS CUI [2]
C2348568
is currently being treated with any of the following medications: *over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat [xenical®] and sibutramine [meridia®]); *oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; *drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide [reglan®]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; *investigational medications
Descripción

Anti-Obesity Agents Non-Prescription | Herbal supplement | Anti-Obesity Agents | orlistat | Xenical | sibutramine | Meridia | Systemic steroids Oral | Systemic steroids Intravenous | Systemic steroids Intramuscular | Steroids Oral | inhaled steroids | Steroids Intrapulmonary | Systemic Absorption Rate High | Pharmaceutical Preparations Affecting Gastrointestinal Motility | Dopamine Antagonists | Metoclopramide | Reglan | Opiates | Anticholinergic Agents | Macrolide Antibiotics chronic | Erythromycin | Erythromycin Derivative | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0376607
UMLS CUI [1,2]
C0013231
UMLS CUI [2]
C1504473
UMLS CUI [3]
C0376607
UMLS CUI [4]
C0076275
UMLS CUI [5]
C0732649
UMLS CUI [6]
C0074493
UMLS CUI [7]
C0635898
UMLS CUI [8,1]
C2825233
UMLS CUI [8,2]
C1527415
UMLS CUI [9,1]
C2825233
UMLS CUI [9,2]
C1522726
UMLS CUI [10,1]
C2825233
UMLS CUI [10,2]
C1556154
UMLS CUI [11,1]
C0038317
UMLS CUI [11,2]
C1527415
UMLS CUI [12]
C2065041
UMLS CUI [13,1]
C0038317
UMLS CUI [13,2]
C1522224
UMLS CUI [14,1]
C3850076
UMLS CUI [14,2]
C1521828
UMLS CUI [14,3]
C0205250
UMLS CUI [15,1]
C0013227
UMLS CUI [15,2]
C0392760
UMLS CUI [15,3]
C0017184
UMLS CUI [16]
C0242702
UMLS CUI [17]
C0025853
UMLS CUI [18]
C0034977
UMLS CUI [19]
C0376196
UMLS CUI [20]
C0242896
UMLS CUI [21,1]
C0003240
UMLS CUI [21,2]
C0205191
UMLS CUI [22]
C0014806
UMLS CUI [23,1]
C0014806
UMLS CUI [23,2]
C1527240
UMLS CUI [24]
C0013230
has a history or presence of any of the following: *eating disorders (including anorexia and/or bulimia); *bariatric surgery (gastric bypass, gastric banding, or gastroplasty)
Descripción

Eating Disorders | Anorexia | Bulimia | Bariatric Surgery | Gastric Bypass | Partitioning of stomach using band | Gastroplasty

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013473
UMLS CUI [2]
C0003123
UMLS CUI [3]
C0006370
UMLS CUI [4]
C1456587
UMLS CUI [5]
C0017125
UMLS CUI [6]
C1960832
UMLS CUI [7]
C0017193
is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study
Descripción

Enrollment Weight Reduction Program | Enrollment Weight Reduction Program Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C3179079
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C3179079
UMLS CUI [2,3]
C1301732
has donated blood within 30 days of study start or plans to donate blood during the duration of the study
Descripción

Blood Donation | Blood Donation Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1301732
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00467649

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
has a clinical diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
has an hba1c >7.0% and ≤10.0%
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
has a bmi of ≥25 kg/m^2 and ≤50 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Insulin regime | Insulin U/day | Insulin regime Pre-existing Absent | Patient Appropriate Initiation Basal insulin
Item
has been on a regimen of insulin for less than 6 months and is taking less than 50 u total of insulin per day, or has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy
boolean
C0557978 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0557978 (UMLS CUI [3,1])
C2347662 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C1548787 (UMLS CUI [4,2])
C1704686 (UMLS CUI [4,3])
C0650607 (UMLS CUI [4,4])
Item Group
C0680251 (UMLS CUI)
Recurrent severe hypoglycemia Treatment required for
Item
has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months
boolean
C0342316 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Requirement Pharmaceutical Preparations Stimulating Gastrointestinal Motility
Item
requires the use of drugs that stimulate gastrointestinal motility
boolean
C1514873 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1948023 (UMLS CUI [1,3])
C0017184 (UMLS CUI [1,4])
Symlin | Study Subject Participation Status
Item
has been previously treated with symlin (or has participated in a symlin clinical study)
boolean
C1174780 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Anti-Obesity Agents Non-Prescription | Herbal supplement | Anti-Obesity Agents | orlistat | Xenical | sibutramine | Meridia | Systemic steroids Oral | Systemic steroids Intravenous | Systemic steroids Intramuscular | Steroids Oral | inhaled steroids | Steroids Intrapulmonary | Systemic Absorption Rate High | Pharmaceutical Preparations Affecting Gastrointestinal Motility | Dopamine Antagonists | Metoclopramide | Reglan | Opiates | Anticholinergic Agents | Macrolide Antibiotics chronic | Erythromycin | Erythromycin Derivative | Investigational New Drugs
Item
is currently being treated with any of the following medications: *over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat [xenical®] and sibutramine [meridia®]); *oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; *drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide [reglan®]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; *investigational medications
boolean
C0376607 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
C1504473 (UMLS CUI [2])
C0376607 (UMLS CUI [3])
C0076275 (UMLS CUI [4])
C0732649 (UMLS CUI [5])
C0074493 (UMLS CUI [6])
C0635898 (UMLS CUI [7])
C2825233 (UMLS CUI [8,1])
C1527415 (UMLS CUI [8,2])
C2825233 (UMLS CUI [9,1])
C1522726 (UMLS CUI [9,2])
C2825233 (UMLS CUI [10,1])
C1556154 (UMLS CUI [10,2])
C0038317 (UMLS CUI [11,1])
C1527415 (UMLS CUI [11,2])
C2065041 (UMLS CUI [12])
C0038317 (UMLS CUI [13,1])
C1522224 (UMLS CUI [13,2])
C3850076 (UMLS CUI [14,1])
C1521828 (UMLS CUI [14,2])
C0205250 (UMLS CUI [14,3])
C0013227 (UMLS CUI [15,1])
C0392760 (UMLS CUI [15,2])
C0017184 (UMLS CUI [15,3])
C0242702 (UMLS CUI [16])
C0025853 (UMLS CUI [17])
C0034977 (UMLS CUI [18])
C0376196 (UMLS CUI [19])
C0242896 (UMLS CUI [20])
C0003240 (UMLS CUI [21,1])
C0205191 (UMLS CUI [21,2])
C0014806 (UMLS CUI [22])
C0014806 (UMLS CUI [23,1])
C1527240 (UMLS CUI [23,2])
C0013230 (UMLS CUI [24])
Eating Disorders | Anorexia | Bulimia | Bariatric Surgery | Gastric Bypass | Partitioning of stomach using band | Gastroplasty
Item
has a history or presence of any of the following: *eating disorders (including anorexia and/or bulimia); *bariatric surgery (gastric bypass, gastric banding, or gastroplasty)
boolean
C0013473 (UMLS CUI [1])
C0003123 (UMLS CUI [2])
C0006370 (UMLS CUI [3])
C1456587 (UMLS CUI [4])
C0017125 (UMLS CUI [5])
C1960832 (UMLS CUI [6])
C0017193 (UMLS CUI [7])
Enrollment Weight Reduction Program | Enrollment Weight Reduction Program Planned
Item
is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study
boolean
C1516879 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C1516879 (UMLS CUI [2,1])
C3179079 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Blood Donation | Blood Donation Planned
Item
has donated blood within 30 days of study start or plans to donate blood during the duration of the study
boolean
C0005794 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
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