ID

23355

Descrição

Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00359879

Link

https://clinicaltrials.gov/show/NCT00359879

Palavras-chave

Versões (1)
  1. 03/07/2017 03/07/2017 -
Transferido a

3 de julho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00359879

Inglês

Eligibility Type 2 Diabetes NCT00359879

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes.
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (su) alone;
Descrição

Metformin | Sulfonylurea

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0038766
*thiazolidinedione (tzd) alone; *a combination of metformin and su; *a combination of metformin and tzd.
Descrição

Thiazolidinediones | Metformin | Sulfonylurea

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0038766
hba1c between 7.1% and 10.0%, inclusive.
Descrição

Glycosylated hemoglobin A

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019018
body mass index (bmi) > 25 kg/m^2 and < 45 kg/m^2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
Descrição

Study Subject Participation Status | Interventional procedure | Therapeutic procedure | Operative Surgical Procedures | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0184661
UMLS CUI [3]
C0087111
UMLS CUI [4]
C0543467
UMLS CUI [5]
C0013230
have characteristics contraindicating metformin, su, or tzd use.
Descrição

Medical contraindication Metformin | Medical contraindication Sulfonylurea | Medical contraindication Thiazolidinediones

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0038766
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C1257987
are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.
Descrição

Glucocorticoid therapy systemic chronic | Topical glucocorticoid | Glucocorticoids Inhalation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0744425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205191
UMLS CUI [2]
C0017712
UMLS CUI [3,1]
C0017710
UMLS CUI [3,2]
C0205535
have used any prescription drug to promote weight loss within 3 months prior to screening.
Descrição

Weight-Loss Agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0376606
are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening;
Descrição

Insulin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021641
*alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility
Descrição

alpha-Glucosidase Inhibitors | Meglitinide | Pharmaceutical Preparations Affecting Gastrointestinal Motility

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1299007
UMLS CUI [2]
C0065880
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0017184
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Similar models

Eligibility Type 2 Diabetes NCT00359879

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Metformin | Sulfonylurea
Item
have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (su) alone;
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
Thiazolidinediones | Metformin | Sulfonylurea
Item
*thiazolidinedione (tzd) alone; *a combination of metformin and su; *a combination of metformin and tzd.
boolean
C1257987 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
Glycosylated hemoglobin A
Item
hba1c between 7.1% and 10.0%, inclusive.
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) > 25 kg/m^2 and < 45 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Interventional procedure | Therapeutic procedure | Operative Surgical Procedures | Investigational New Drugs
Item
have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0013230 (UMLS CUI [5])
Medical contraindication Metformin | Medical contraindication Sulfonylurea | Medical contraindication Thiazolidinediones
Item
have characteristics contraindicating metformin, su, or tzd use.
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C1257987 (UMLS CUI [3,2])
Glucocorticoid therapy systemic chronic | Topical glucocorticoid | Glucocorticoids Inhalation
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 immediately prior to screening.
boolean
C0744425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0017712 (UMLS CUI [2])
C0017710 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
Weight-Loss Agents
Item
have used any prescription drug to promote weight loss within 3 months prior to screening.
boolean
C0376606 (UMLS CUI [1])
Insulin
Item
are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening;
boolean
C0021641 (UMLS CUI [1])
alpha-Glucosidase Inhibitors | Meglitinide | Pharmaceutical Preparations Affecting Gastrointestinal Motility
Item
*alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility
boolean
C1299007 (UMLS CUI [1])
C0065880 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0017184 (UMLS CUI [3,3])
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