Informações:
Falhas:
ID
20689
Descrição
Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00396071
Link
https://clinicaltrials.gov/show/NCT00396071
Palavras-chave
Versões (1)
- 11/03/2017 11/03/2017 -
Transferido a
11 de março de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00396071
Eligibility Diabetes Mellitus, Type 2 NCT00396071
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT00396071
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Non-Insulin-Dependent Diabetes Mellitus disease length | Metformin Dose Stable U/day
Item
patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
C0872146 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Metformin Dose Maintenance
Item
agreement to maintain the same dose of metformin throughout the study
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0024501 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0024501 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) in the range of 22-35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
hba1c in the range of 7.0 to 9.0%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fpg <200 mg/dl (11.1 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Dietary Habits Maintenance | exercise habits Maintenance
Item
agreement to maintain prior diet and exercise habits during the full course of the study
boolean
C0086152 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C2220423 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C0024501 (UMLS CUI [1,2])
C2220423 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
Protocol Compliance | Informed Consent
Item
ability to comply with all study requirements and signed informed consent to participate in the study
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
a history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Complications Diabetic Metabolic
Item
a history of acute metabolic diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0311400 (UMLS CUI [1,2])
Complications of Diabetes Mellitus Evidence
Item
evidence of significant diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,2])
Insulin regime
Item
insulin treatment for longer than 10 days within the past 6 months
boolean
C0557978 (UMLS CUI [1])
Antidiabetics Oral | Metformin
Item
treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])