ID

32670

Descripción

Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00434954

Link

https://clinicaltrials.gov/show/NCT00434954

Palabras clave

Versiones (1)
  1. 11/11/18 11/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00434954

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00434954

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start
Descripción

Diet therapy | Exercise | Metformin Immediate Release Maximum Tolerated Dose Stable | Metformin Extended Release Maximum Tolerated Dose Stable | Combined Modality Therapy | Metformin | Sulfonylureas | Meglitinide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C1708470
UMLS CUI [3,3]
C0752079
UMLS CUI [3,4]
C0205360
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C1707968
UMLS CUI [4,3]
C0752079
UMLS CUI [4,4]
C0205360
UMLS CUI [5]
C0009429
UMLS CUI [6]
C0025598
UMLS CUI [7]
C0038766
UMLS CUI [8]
C0065880
have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start
Descripción

Absence Thiazolidinediones chronic | Absence alpha-Glucosidase Inhibitors chronic | Absence Insulin Formulation chronic | Exception Emergency Situation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1257987
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1299007
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C0524527
UMLS CUI [3,4]
C0205191
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0013956
have an hba1c between 6.5% and 10.0%, inclusive
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
have a body mass index (bmi) between 25 kg/m^2 and 40 kg/m^2, inclusive
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
have type 1 diabetes or known latent autoimmune diabetes in adults
Descripción

Diabetes Mellitus, Insulin-Dependent | Latent Autoimmune Diabetes in Adults

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C1739108
are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start
Descripción

Systemic Glucocorticoids chronic | Exception Pharmaceutical Preparations Topical | Exception Inhalation Drug Administration | Systemic Glucocorticoids Recently

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1710439
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001559
UMLS CUI [4,1]
C3540777
UMLS CUI [4,2]
C0332185
are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)
Descripción

Pharmacotherapy Gastrointestinal Disease | Pharmaceutical Preparations Affecting Gastrointestinal Motility | Metoclopramide | Cisapride | Macrolide Antibiotics chronic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0017178
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0017184
UMLS CUI [3]
C0025853
UMLS CUI [4]
C0072916
UMLS CUI [5,1]
C0003240
UMLS CUI [5,2]
C0205191
have used any prescription drug to promote weight loss within 3 months prior to study start
Descripción

Weight-Loss Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0376606
have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry
Descripción

Pharmaceutical Preparation Without Approval

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0162696
have previously completed or withdrawn from this study or any other study investigating exenatide or glp-1 analogs
Descripción

Study Subject Participation Status | exenatide | GLP-1 analogues

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0167117
UMLS CUI [3]
C4301632
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Eligibility Type 2 Diabetes Mellitus NCT00434954

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diet therapy | Exercise | Metformin Immediate Release Maximum Tolerated Dose Stable | Metformin Extended Release Maximum Tolerated Dose Stable | Combined Modality Therapy | Metformin | Sulfonylureas | Meglitinide
Item
have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C1708470 (UMLS CUI [3,2])
C0752079 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C0025598 (UMLS CUI [4,1])
C1707968 (UMLS CUI [4,2])
C0752079 (UMLS CUI [4,3])
C0205360 (UMLS CUI [4,4])
C0009429 (UMLS CUI [5])
C0025598 (UMLS CUI [6])
C0038766 (UMLS CUI [7])
C0065880 (UMLS CUI [8])
Absence Thiazolidinediones chronic | Absence alpha-Glucosidase Inhibitors chronic | Absence Insulin Formulation chronic | Exception Emergency Situation
Item
have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start
boolean
C0332197 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1299007 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0524527 (UMLS CUI [3,3])
C0205191 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0013956 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
have an hba1c between 6.5% and 10.0%, inclusive
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
have a body mass index (bmi) between 25 kg/m^2 and 40 kg/m^2, inclusive
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Latent Autoimmune Diabetes in Adults
Item
have type 1 diabetes or known latent autoimmune diabetes in adults
boolean
C0011854 (UMLS CUI [1])
C1739108 (UMLS CUI [2])
Systemic Glucocorticoids chronic | Exception Pharmaceutical Preparations Topical | Exception Inhalation Drug Administration | Systemic Glucocorticoids Recently
Item
are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1710439 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0001559 (UMLS CUI [3,2])
C3540777 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Pharmacotherapy Gastrointestinal Disease | Pharmaceutical Preparations Affecting Gastrointestinal Motility | Metoclopramide | Cisapride | Macrolide Antibiotics chronic
Item
are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)
boolean
C0013216 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0017184 (UMLS CUI [2,3])
C0025853 (UMLS CUI [3])
C0072916 (UMLS CUI [4])
C0003240 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
Weight-Loss Agents
Item
have used any prescription drug to promote weight loss within 3 months prior to study start
boolean
C0376606 (UMLS CUI [1])
Pharmaceutical Preparation Without Approval
Item
have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry
boolean
C0013227 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0162696 (UMLS CUI [1,3])
Study Subject Participation Status | exenatide | GLP-1 analogues
Item
have previously completed or withdrawn from this study or any other study investigating exenatide or glp-1 analogs
boolean
C2348568 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C4301632 (UMLS CUI [3])
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