ID

12951

Beschrijving

A Study to Evaluate the Efficacy and Safety of BRL 49653C in Non-insulin Dependent Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01706211

Link

https://clinicaltrials.gov/show/NCT01706211

Trefwoorden

  1. 07-01-16 07-01-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

7 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy NCT01706211

Eligibility Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy NCT01706211

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women between 30-80 years of age inclusive at time of enrolment.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients who had non-independent diabetes mellitus (niddm) defined by the criteria of the national diabetes data group.
Beschrijving

non-independent diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
patients who had sulphonylurea therapy for at least 6 months and a constant dose for at least 2 months prior to visit 1.
Beschrijving

sulphonylurea

Datatype

boolean

Alias
UMLS CUI [1]
C0038766
patients who had fasting plasma glucose <= 15.0 mmol/l at screening. hemoglobin a1c >= 7.5%.
Beschrijving

patients who had fasting plasma glucose <= 15.0 mmol/l at screening. hemoglobin a1c >= 7.5%.

Datatype

boolean

Alias
UMLS CUI [1]
C0202042
UMLS CUI [2]
C0019018
female patients must be (1) post-menopausal, i.e. > 6 months without menstrual period, surgically sterile, or (2) using hormonal contraceptives or intrauterine contraceptive devices. female patients who were taking hormonal contraceptives must also use an additional barrier form or intrauterine form of birth control.
Beschrijving

contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
patients who had given their written informed consent to participate.
Beschrijving

written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients who were pregnant, breast feeding or planning a pregnancy during the course of the study.
Beschrijving

female patients who were pregnant, breast feeding or planning a pregnancy during the course of the study.

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
patients who had a fasting plasma glucose > 15.0 mmol/l at screening, or severity of diabetes mellitus requiring administration of insulin, or patients with ketonuria.
Beschrijving

patients who had a fasting plasma glucose > 15.0 mmol/l at screening, or severity of diabetes mellitus requiring administration of insulin, or patients with ketonuria.

Datatype

boolean

Alias
UMLS CUI [1]
C0202042
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0162275
patients who had clinically significant renal or hepatic disease (i.e., patients with serum creatinine > 160 micromol/l (1.8 mg/dl); alt, ast, total bilirubin, gamma gt, or alkaline phosphatase more than 2.5 times the upper limit of the normal laboratory range).
Beschrijving

renal or hepatic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1287351
any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram which in the judgment of the investigator would preclude safe completion of the study.
Beschrijving

any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram which in the judgment of the investigator would preclude safe completion of the study.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients who had leukocyte count < 3000/mm3 or platelet count <120,000/mm3.
Beschrijving

leukocyte count < 3000/mm3 or platelet count <120,000/mm3

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
systolic blood pressure >180mmhg or diastolic blood pressure >114mmhg while on appropriate hypertensive therapy.
Beschrijving

blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0005823
significant anemia (hemoglobin < 11 g/dl for males or < 10g/dl for females) or diagnosis of porphyria.
Beschrijving

anemia or porphyria

Datatype

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C3463940
symptomatic diabetic neuropathy of sufficient severity to require treatment for control of symptoms (eg, painful peripheral neuropathy, symptomatic orthostatic hypotension, urinary retention, gastric stasis, pedal ulcers).
Beschrijving

diabetic neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0011882
diabetic retinopathy imminently requiring treatment for preserving or restoring vision.
Beschrijving

diabetic retinopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0011884
body mass index(bmi) < 22 and >38 kg/m2 (formula: bmi= weight, kg ÷height, m2)and variation in body weight of >=5% between screening and visit2.
Beschrijving

body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855

Similar models

Eligibility Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy NCT01706211

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
men or women between 30-80 years of age inclusive at time of enrolment.
boolean
C0001779 (UMLS CUI [1])
non-independent diabetes mellitus
Item
patients who had non-independent diabetes mellitus (niddm) defined by the criteria of the national diabetes data group.
boolean
C0011849 (UMLS CUI [1])
sulphonylurea
Item
patients who had sulphonylurea therapy for at least 6 months and a constant dose for at least 2 months prior to visit 1.
boolean
C0038766 (UMLS CUI [1])
patients who had fasting plasma glucose <= 15.0 mmol/l at screening. hemoglobin a1c >= 7.5%.
Item
patients who had fasting plasma glucose <= 15.0 mmol/l at screening. hemoglobin a1c >= 7.5%.
boolean
C0202042 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
contraceptive methods
Item
female patients must be (1) post-menopausal, i.e. > 6 months without menstrual period, surgically sterile, or (2) using hormonal contraceptives or intrauterine contraceptive devices. female patients who were taking hormonal contraceptives must also use an additional barrier form or intrauterine form of birth control.
boolean
C0700589 (UMLS CUI [1])
written informed consent
Item
patients who had given their written informed consent to participate.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
female patients who were pregnant, breast feeding or planning a pregnancy during the course of the study.
Item
female patients who were pregnant, breast feeding or planning a pregnancy during the course of the study.
boolean
C0032961 (UMLS CUI [1])
patients who had a fasting plasma glucose > 15.0 mmol/l at screening, or severity of diabetes mellitus requiring administration of insulin, or patients with ketonuria.
Item
patients who had a fasting plasma glucose > 15.0 mmol/l at screening, or severity of diabetes mellitus requiring administration of insulin, or patients with ketonuria.
boolean
C0202042 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0162275 (UMLS CUI [3])
renal or hepatic disease
Item
patients who had clinically significant renal or hepatic disease (i.e., patients with serum creatinine > 160 micromol/l (1.8 mg/dl); alt, ast, total bilirubin, gamma gt, or alkaline phosphatase more than 2.5 times the upper limit of the normal laboratory range).
boolean
C0201976 (UMLS CUI [1])
C1287351 (UMLS CUI [2])
any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram which in the judgment of the investigator would preclude safe completion of the study.
Item
any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram which in the judgment of the investigator would preclude safe completion of the study.
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
leukocyte count < 3000/mm3 or platelet count <120,000/mm3
Item
patients who had leukocyte count < 3000/mm3 or platelet count <120,000/mm3.
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
blood pressure
Item
systolic blood pressure >180mmhg or diastolic blood pressure >114mmhg while on appropriate hypertensive therapy.
boolean
C0005823 (UMLS CUI [1])
anemia or porphyria
Item
significant anemia (hemoglobin < 11 g/dl for males or < 10g/dl for females) or diagnosis of porphyria.
boolean
C0002871 (UMLS CUI [1])
C3463940 (UMLS CUI [2])
diabetic neuropathy
Item
symptomatic diabetic neuropathy of sufficient severity to require treatment for control of symptoms (eg, painful peripheral neuropathy, symptomatic orthostatic hypotension, urinary retention, gastric stasis, pedal ulcers).
boolean
C0011882 (UMLS CUI [1])
diabetic retinopathy
Item
diabetic retinopathy imminently requiring treatment for preserving or restoring vision.
boolean
C0011884 (UMLS CUI [1])
body mass index
Item
body mass index(bmi) < 22 and >38 kg/m2 (formula: bmi= weight, kg ÷height, m2)and variation in body weight of >=5% between screening and visit2.
boolean
C1305855 (UMLS CUI [1])

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