ID

23356

Description

A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00360334

Lien

https://clinicaltrials.gov/show/NCT00360334

Mots-clés

Versions (1)
  1. 03/07/2017 03/07/2017 -
Téléchargé le

3 juillet 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00360334

Anglais

Eligibility Type 2 Diabetes NCT00360334

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
currently being treated with the following: dual or triple oral therapy - on a stable combination and dose for at least 3 months.
Description

Therapeutic procedure Oral Duplicate | Therapeutic procedure Oral Triplicate | Combined Modality Therapy Dose Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205173
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205174
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
hba1c between 7.5% and 10.0%.
Description

Glycosylated hemoglobin A

Type de données

boolean

Alias
UMLS CUI [1]
C0019018
bmi >27.
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
receive 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 study.
Description

Glucocorticoid therapy systemic chronic | Topical glucocorticoid | Glucocorticoids Inhalation

Type de données

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 participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0184661
UMLS CUI [3]
C0087111
UMLS CUI [4]
C0543467
UMLS CUI [5]
C0013230
treatment with the following medications: *insulin as outpatient therapy within last 3 months; *meglitinides, or acarbose within the last 3 months; *regular use of any drugs that directly affect gastrointestinal motility; *any previous (study) therapy with exenatide or glucagon-like peptide-1 (glp-1) analogue; *anti-obesity agent use within the last 3 months.
Description

Insulin | Meglitinide | Acarbose | Pharmaceutical Preparations Affecting Gastrointestinal Motility | exenatide | Glucagon-Like Peptide 1 Analogue | Anti-Obesity Agents

Type de données

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0065880
UMLS CUI [3]
C0050393
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0017184
UMLS CUI [5]
C0167117
UMLS CUI [6,1]
C0061355
UMLS CUI [6,2]
C0243071
UMLS CUI [7]
C0376607
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Description

Drugs, Non-Prescription

Type de données

boolean

Alias
UMLS CUI [1]
C0013231
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Similar models

Eligibility Type 2 Diabetes NCT00360334

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Therapeutic procedure Oral Duplicate | Therapeutic procedure Oral Triplicate | Combined Modality Therapy Dose Stable
Item
currently being treated with the following: dual or triple oral therapy - on a stable combination and dose for at least 3 months.
boolean
C0087111 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205174 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Glycosylated hemoglobin A
Item
hba1c between 7.5% and 10.0%.
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
bmi >27.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Glucocorticoid therapy systemic chronic | Topical glucocorticoid | Glucocorticoids Inhalation
Item
receive 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 study.
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])
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 a medical or surgical treatment was given) within 30 days prior to entry into the study.
boolean
C2348568 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0013230 (UMLS CUI [5])
Insulin | Meglitinide | Acarbose | Pharmaceutical Preparations Affecting Gastrointestinal Motility | exenatide | Glucagon-Like Peptide 1 Analogue | Anti-Obesity Agents
Item
treatment with the following medications: *insulin as outpatient therapy within last 3 months; *meglitinides, or acarbose within the last 3 months; *regular use of any drugs that directly affect gastrointestinal motility; *any previous (study) therapy with exenatide or glucagon-like peptide-1 (glp-1) analogue; *anti-obesity agent use within the last 3 months.
boolean
C0021641 (UMLS CUI [1])
C0065880 (UMLS CUI [2])
C0050393 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0017184 (UMLS CUI [4,3])
C0167117 (UMLS CUI [5])
C0061355 (UMLS CUI [6,1])
C0243071 (UMLS CUI [6,2])
C0376607 (UMLS CUI [7])
Drugs, Non-Prescription
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013231 (UMLS CUI [1])
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