Informações:
Falhas:
ID
20691
Descrição
Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00396357
Link
https://clinicaltrials.gov/show/NCT00396357
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 NCT00396357
Eligibility Diabetes Mellitus, Type 2 NCT00396357
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT00396357
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
18-78 years inclusive
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes diagnosis at least 2 months prior to study entry
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,2])
Body mass index
Item
body mass index in the range of 22-45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
hba1c in the range of 6.5 to 9% inclusive
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose <270 mg/dl (15 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
a history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
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 | Antidiabetics Oral
Item
treatment with insulin or any other oral antidiabetic agents
boolean
C0021641 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Congestive heart failure Requirement Pharmacotherapy
Item
congestive heart failure requiring pharmacologic treatment
boolean
C0018802 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Renal dysfunction | Metformin Labeling criteria | Creatinine measurement, serum | Gender
Item
clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)
boolean
C3279454 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C1947902 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0025598 (UMLS CUI [2,1])
C1947902 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
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])