ID

12951

Description

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

Keywords

Versions (1)
  1. 1/7/16 1/7/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 7, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy NCT01706211

English

Eligibility Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy NCT01706211

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

age

Data type

boolean

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

non-independent diabetes mellitus

Data type

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.
Description

sulphonylurea

Data type

boolean

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

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

Data type

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.
Description

contraceptive methods

Data type

boolean

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

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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.
Description

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.

Data type

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).
Description

renal or hepatic disease

Data type

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.
Description

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.

Data type

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.
Description

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

Data type

boolean

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

blood pressure

Data type

boolean

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

anemia or porphyria

Data type

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).
Description

diabetic neuropathy

Data type

boolean

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

diabetic retinopathy

Data type

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.
Description

body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
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Similar models

Eligibility Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy NCT01706211

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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