ID

32737

Descripción

Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00641407

Link

https://clinicaltrials.gov/show/NCT00641407

Palabras clave

Versiones (1)
  1. 13/11/18 13/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00641407

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00641407

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women aged 30-70 years, with a duration of known diabetes > 2 years
Descripción

Age | Diabetes Mellitus Duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0449238
and treated with stable doses of two oral antihyperglycemic agents (metformin and sulfonylurea) for at least 90 days were selected for the study
Descripción

Oral hypoglycemic Quantity | Metformin Dose Stable | Sulfonylureas Dose Stable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0038766
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
body mass index less than 40 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
hba1c level between 7.5 and 10%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
and fasting plasma glucose of 120 mg/dl or greater.
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
exclusion criteria included pregnancy or breast-feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous use of insulin or other antihyperglycemic drugs
Descripción

Insulin | Hypoglycemic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0020616
investigational drug within the previous 3 months
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
use of agents affecting glycemic control (systemic glucocorticoids, and weight-loss drugs)
Descripción

Pharmaceutical Preparations Affecting Glycaemia control | Glucocorticoids, Systemic | Weight-Loss Agents

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3267174
UMLS CUI [2]
C3540777
UMLS CUI [3]
C0376606
presence of any clinically relevant somatic or mental diseases
Descripción

Disease Somatic | Mental disorders

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2986476
UMLS CUI [2]
C0004936
to minimize the likelihood of including subjects with late-onset type 1 diabetes
Descripción

Diabetes mellitus, insulin-dependent, late onset

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1865291
candidate with a positive test for anti-gad antibody or with fasting plasma c-peptide less than 0.25 pmol/ml were excluded
Descripción

Anti-GAD antibody positive | Fasting C-peptide level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1167896
UMLS CUI [2]
C2208720
also excluded were patients with abnormal safety laboratory tests
Descripción

Safety Laboratory test result abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C0438215
including liver enzymes (alt, ast, afos) higher than three times the upper limit of normal and serum creatinine > 1.4 mg/dl)
Descripción

Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0235996
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151849
UMLS CUI [5]
C0201976
history of drug abuse
Descripción

Drug abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013146
poor compliance with the 8-point daily glucose profile measurement
Descripción

Poor compliance Glucose measurement Daily

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C0337438
UMLS CUI [1,3]
C0332173
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00641407

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus Duration
Item
men and women aged 30-70 years, with a duration of known diabetes > 2 years
boolean
C0001779 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Oral hypoglycemic Quantity | Metformin Dose Stable | Sulfonylureas Dose Stable
Item
and treated with stable doses of two oral antihyperglycemic agents (metformin and sulfonylurea) for at least 90 days were selected for the study
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0038766 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Body mass index
Item
body mass index less than 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c level between 7.5 and 10%
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
and fasting plasma glucose of 120 mg/dl or greater.
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
exclusion criteria included pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Insulin | Hypoglycemic Agents
Item
previous use of insulin or other antihyperglycemic drugs
boolean
C0021641 (UMLS CUI [1])
C0020616 (UMLS CUI [2])
Investigational New Drugs
Item
investigational drug within the previous 3 months
boolean
C0013230 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Glycaemia control | Glucocorticoids, Systemic | Weight-Loss Agents
Item
use of agents affecting glycemic control (systemic glucocorticoids, and weight-loss drugs)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3267174 (UMLS CUI [1,3])
C3540777 (UMLS CUI [2])
C0376606 (UMLS CUI [3])
Disease Somatic | Mental disorders
Item
presence of any clinically relevant somatic or mental diseases
boolean
C0012634 (UMLS CUI [1,1])
C2986476 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
Diabetes mellitus, insulin-dependent, late onset
Item
to minimize the likelihood of including subjects with late-onset type 1 diabetes
boolean
C1865291 (UMLS CUI [1])
Anti-GAD antibody positive | Fasting C-peptide level
Item
candidate with a positive test for anti-gad antibody or with fasting plasma c-peptide less than 0.25 pmol/ml were excluded
boolean
C1167896 (UMLS CUI [1])
C2208720 (UMLS CUI [2])
Safety Laboratory test result abnormal
Item
also excluded were patients with abnormal safety laboratory tests
boolean
C0036043 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Creatinine measurement, serum
Item
including liver enzymes (alt, ast, afos) higher than three times the upper limit of normal and serum creatinine > 1.4 mg/dl)
boolean
C0235996 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Drug abuse
Item
history of drug abuse
boolean
C0013146 (UMLS CUI [1])
Poor compliance Glucose measurement Daily
Item
poor compliance with the 8-point daily glucose profile measurement
boolean
C0032646 (UMLS CUI [1,1])
C0337438 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
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