ID

39007

Beschreibung

Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00940472

Link

https://clinicaltrials.gov/show/NCT00940472

Stichworte

  1. 19.11.19 19.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

19. November 2019

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Diabetes Type 2 NCT00940472

Eligibility Diabetes Type 2 NCT00940472

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages eligible for study: 40 to 60 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
with type 2 diabetes evolution < 5 years without pharmacological treatment 1 month prior to the screening
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length | Pharmacotherapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0332197
fasting glucose = 130-200 mg/dl
Beschreibung

Glucose measurement, fasting

Datentyp

boolean

Alias
UMLS CUI [1]
C0202045
hba1c of 7% to 9%
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
blood pressure < 140/80 mmhg
Beschreibung

Blood pressure determination

Datentyp

boolean

Alias
UMLS CUI [1]
C0005824
ability to communicate and meet the requirements of the study
Beschreibung

Able to communicate | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C2364293
UMLS CUI [2]
C0525058
signed written informed consent before to conducting any study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
body mass index (bmi) of 25 kg/m2 to 35 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
suspected or confirmed pregnancy
Beschreibung

Pregnancy Suspected | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0032961
nursing
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
inability to secure the non-pregnant during the study duration
Beschreibung

Contraceptive methods Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1299582
hypersensitivity to any biguanides
Beschreibung

Biguanide allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571647
use of an investigational drug within 30 days prior to the screening
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
liver failure, heart failure, kidney failure or thyroid disease
Beschreibung

Liver Failure | Heart failure | Kidney Failure | Thyroid Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0085605
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0035078
UMLS CUI [4]
C0040128
periods of acute or chronic diarrhea or vomiting
Beschreibung

Diarrhea | Chronic diarrhea | Vomiting | Chronic vomiting

Datentyp

boolean

Alias
UMLS CUI [1]
C0011991
UMLS CUI [2]
C0401151
UMLS CUI [3]
C0042963
UMLS CUI [4]
C0232598
chronic hepatic disease
Beschreibung

Chronic liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0341439
total cholesterol >300 mg/dl
Beschreibung

Serum total cholesterol measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1445957
triglycerides >400 mg/dl
Beschreibung

Triglycerides measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202236

Ähnliche Modelle

Eligibility Diabetes Type 2 NCT00940472

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages eligible for study: 40 to 60 years
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length | Pharmacotherapy Absent
Item
with type 2 diabetes evolution < 5 years without pharmacological treatment 1 month prior to the screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Glucose measurement, fasting
Item
fasting glucose = 130-200 mg/dl
boolean
C0202045 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c of 7% to 9%
boolean
C0474680 (UMLS CUI [1])
Blood pressure determination
Item
blood pressure < 140/80 mmhg
boolean
C0005824 (UMLS CUI [1])
Able to communicate | Protocol Compliance
Item
ability to communicate and meet the requirements of the study
boolean
C2364293 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Informed Consent
Item
signed written informed consent before to conducting any study
boolean
C0021430 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 25 kg/m2 to 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy Suspected | Pregnancy
Item
suspected or confirmed pregnancy
boolean
C0032961 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
Breast Feeding
Item
nursing
boolean
C0006147 (UMLS CUI [1])
Contraceptive methods Unable
Item
inability to secure the non-pregnant during the study duration
boolean
C0700589 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Biguanide allergy
Item
hypersensitivity to any biguanides
boolean
C0571647 (UMLS CUI [1])
Investigational New Drugs
Item
use of an investigational drug within 30 days prior to the screening
boolean
C0013230 (UMLS CUI [1])
Liver Failure | Heart failure | Kidney Failure | Thyroid Disease
Item
liver failure, heart failure, kidney failure or thyroid disease
boolean
C0085605 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
C0040128 (UMLS CUI [4])
Diarrhea | Chronic diarrhea | Vomiting | Chronic vomiting
Item
periods of acute or chronic diarrhea or vomiting
boolean
C0011991 (UMLS CUI [1])
C0401151 (UMLS CUI [2])
C0042963 (UMLS CUI [3])
C0232598 (UMLS CUI [4])
Chronic liver disease
Item
chronic hepatic disease
boolean
C0341439 (UMLS CUI [1])
Serum total cholesterol measurement
Item
total cholesterol >300 mg/dl
boolean
C1445957 (UMLS CUI [1])
Triglycerides measurement
Item
triglycerides >400 mg/dl
boolean
C0202236 (UMLS CUI [1])

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