Informações:
Falhas:
ID
20688
Descrição
Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019); ODM derived from: https://clinicaltrials.gov/show/NCT00393705
Link
https://clinicaltrials.gov/show/NCT00393705
Palavras-chave
Versões (1)
- 10/03/2017 10/03/2017 -
Transferido a
10 de março de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00393705
Eligibility Diabetes Mellitus, Type 2 NCT00393705
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT00393705
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes (world health organization [who] classification).
boolean
C0011860 (UMLS CUI [1])
Age
Item
are at least 30 years of age and less than 75 years of age.
boolean
C0001779 (UMLS CUI [1])
Hypoglycemic Agents | Premixed insulin Analog Frequency | Insulin Lispro Mixture low | Biphasic insulin aspart | Metformin U/day
Item
have been receiving hypoglycemic treatment with premixed insulin analogue (either with insulin lispro lm or biphasic insulin aspart 30/70) administered twice daily in combination with at least 1500 milligrams (mg) of metformin per day for at least 60 days immediately prior to the study.
boolean
C0020616 (UMLS CUI [1])
C2069057 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C0376249 (UMLS CUI [2,3])
C0293359 (UMLS CUI [3,1])
C0439962 (UMLS CUI [3,2])
C0205251 (UMLS CUI [3,3])
C1273270 (UMLS CUI [4])
C0025598 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
C2069057 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C0376249 (UMLS CUI [2,3])
C0293359 (UMLS CUI [3,1])
C0439962 (UMLS CUI [3,2])
C0205251 (UMLS CUI [3,3])
C1273270 (UMLS CUI [4])
C0025598 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
Glycosylated haemoglobin increased
Item
have a hemoglobin a1c 1.2 to 1.8 times the upper limit of the normal reference range at the local laboratory at visit 1 or
boolean
C0239940 (UMLS CUI [1])
Blood glucose measurement Value Postprandial
Item
have at least 6 of 9 of the postprandial blood glucose values recorded in the period between visit 1 and visit 2 exceeding 180 milligrams per 100 milliliters (mg/dl) (10.0 millimole per liter [mmol/l]).
boolean
C0392201 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
C0376674 (UMLS CUI [1,3])
C1522609 (UMLS CUI [1,2])
C0376674 (UMLS CUI [1,3])
Informed Consent
Item
have given written informed consent to participate in this study in accordance with local regulations.
boolean
C0021430 (UMLS CUI [1])
Antidiabetics Oral
Item
are taking any other oral anti-diabetic medication (oam) not mentioned in inclusion criterion.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,2])
Body mass index
Item
have a body mass index greater than 40 kilograms per meter squared (kg/m2).
boolean
C1305855 (UMLS CUI [1])
Hypoglycemia Severe Episode Quantity
Item
have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Congestive heart failure
Item
have congestive heart failure.
boolean
C0018802 (UMLS CUI [1])
Sleep-wake cycle disturbance
Item
have an irregular sleep/wake cycle (for example, patients who sleep during the day and work during the night).
boolean
C1833362 (UMLS CUI [1])