ID

42867

Beschreibung

4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM); ODM derived from: https://clinicaltrials.gov/show/NCT00885118

Link

https://clinicaltrials.gov/show/NCT00885118

Stichworte

Versionen (2)
  1. 03.03.18 03.03.18 -
  2. 17.09.21 17.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

17. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00885118

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00885118

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. japanese male or female patients with t2dm treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
Beschreibung

Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Hypoglycemic Agents Quantity | Exception Thiazolidinediones

Datentyp

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0015259
UMLS CUI [5,1]
C0020616
UMLS CUI [5,2]
C1265611
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1257987
2. hemoglobin a1c (hba1c) at screening (visit 1)
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
for patients treated with 1 other oral antidiabetic drug: hba1c between 6.5% and 9.0%.
Beschreibung

Antidiabetics Oral Quantity | Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0202054
for patients not treated with any antidiabetic drug: hba1c between 7.0% and 10.0%.
Beschreibung

Antidiabetics Absent | Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0202054
3. age between 20 and 70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. body mass index (bmi) between18.0 and 40.0 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
5. signed and dated written informed consent before admission to the trial in accordance with the good clinical practice (gcp) and the local legislation.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent
Beschreibung

Antidiabetics | Insulin | Thiazolidinediones | Oral hypoglycemic Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0021641
UMLS CUI [3]
C1257987
UMLS CUI [4,1]
C0359086
UMLS CUI [4,2]
C1265611
2. fasted blood glucose of >240 mg/dl (>13.3 mmol/l) or a randomly determined blood glucose level of >400 mg/dl (22.2 mmol/l) on 2 consecutive days during wash-out period.
Beschreibung

Fasting blood glucose measurement | Blood glucose measurement Quantity Washout Period

Datentyp

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2,1]
C0392201
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1710661
3. myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
Beschreibung

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
4. clinically relevant concomitant diseases other than t2dm, hyperlipidaemia, and medically treated hypertension before the first administration such as
Beschreibung

Comorbidity Except Non-Insulin-Dependent Diabetes Mellitus | Hyperlipidemia | Hypertensive disease Treated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0011860
UMLS CUI [2]
C0020473
UMLS CUI [3,1]
C0020538
UMLS CUI [3,2]
C1522326
renal insufficiency (calculated estimated glomerular filtration rate <60)
Beschreibung

Renal Insufficiency | Estimated Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
cardiac insufficiency of new york heart association (nyha) ii-iv or other known cardiovascular diseases including hypertension of >160/95 mmhg,
Beschreibung

Heart failure New York Heart Association Classification | Cardiovascular Diseases | Hypertensive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0857121
neurological disorders (such as epilepsy) or psychiatric disorders
Beschreibung

Nervous system disorder | Epilepsy | Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0004936
acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
Beschreibung

Chronic infectious disease | HIV Infection | Hepatitis | Genitourinary tract infection Repeated

Datentyp

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019158
UMLS CUI [4,1]
C1279264
UMLS CUI [4,2]
C0205341
any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder
Beschreibung

Gastrointestinal Diseases | Liver diseases | Respiration Disorders | Endocrine System Diseases | Immune System Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0035204
UMLS CUI [4]
C0014130
UMLS CUI [5]
C0021053
5. patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:
Beschreibung

Pharmaceutical Preparations Additional | Exception Pharmaceutical Preparations Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205369
statins.
Beschreibung

Exception Statins

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0360714
antihypertensives (diuretics not allowed)
Beschreibung

Exception Antihypertensive Agents | Diuretics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0003364
UMLS CUI [2]
C0012798
alpha-blockers for benign prostate hypertrophy
Beschreibung

Exception Adrenergic alpha-Antagonists Benign prostatic hypertrophy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0001641
UMLS CUI [1,3]
C1704272
occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
Beschreibung

Exception Aspirin | Exception Ibuprofen | Exception Acetaminophen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020740
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0000970
6. additional inclusion/exclusion criteria apply
Beschreibung

Clinical Trial Eligibility Criteria Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00885118

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Hypoglycemic Agents Quantity | Exception Thiazolidinediones
Item
1. japanese male or female patients with t2dm treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
boolean
C1556094 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0020616 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1257987 (UMLS CUI [6,2])
Glucohemoglobin measurement
Item
2. hemoglobin a1c (hba1c) at screening (visit 1)
boolean
C0202054 (UMLS CUI [1])
Antidiabetics Oral Quantity | Glucohemoglobin measurement
Item
for patients treated with 1 other oral antidiabetic drug: hba1c between 6.5% and 9.0%.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0202054 (UMLS CUI [2])
Antidiabetics Absent | Glucohemoglobin measurement
Item
for patients not treated with any antidiabetic drug: hba1c between 7.0% and 10.0%.
boolean
C0935929 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
Age
Item
3. age between 20 and 70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
4. body mass index (bmi) between18.0 and 40.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
5. signed and dated written informed consent before admission to the trial in accordance with the good clinical practice (gcp) and the local legislation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics | Insulin | Thiazolidinediones | Oral hypoglycemic Quantity
Item
1. antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent
boolean
C0935929 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0359086 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Fasting blood glucose measurement | Blood glucose measurement Quantity Washout Period
Item
2. fasted blood glucose of >240 mg/dl (>13.3 mmol/l) or a randomly determined blood glucose level of >400 mg/dl (22.2 mmol/l) on 2 consecutive days during wash-out period.
boolean
C0428568 (UMLS CUI [1])
C0392201 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1710661 (UMLS CUI [2,3])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
3. myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Comorbidity Except Non-Insulin-Dependent Diabetes Mellitus | Hyperlipidemia | Hypertensive disease Treated
Item
4. clinically relevant concomitant diseases other than t2dm, hyperlipidaemia, and medically treated hypertension before the first administration such as
boolean
C0009488 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
C0020473 (UMLS CUI [2])
C0020538 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
renal insufficiency (calculated estimated glomerular filtration rate <60)
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
Heart failure New York Heart Association Classification | Cardiovascular Diseases | Hypertensive
Item
cardiac insufficiency of new york heart association (nyha) ii-iv or other known cardiovascular diseases including hypertension of >160/95 mmhg,
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0857121 (UMLS CUI [3])
Nervous system disorder | Epilepsy | Mental disorders
Item
neurological disorders (such as epilepsy) or psychiatric disorders
boolean
C0027765 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
Chronic infectious disease | HIV Infection | Hepatitis | Genitourinary tract infection Repeated
Item
acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
boolean
C0151317 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C1279264 (UMLS CUI [4,1])
C0205341 (UMLS CUI [4,2])
Gastrointestinal Diseases | Liver diseases | Respiration Disorders | Endocrine System Diseases | Immune System Diseases
Item
any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
Pharmaceutical Preparations Additional | Exception Pharmaceutical Preparations Specified
Item
5. patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Exception Statins
Item
statins.
boolean
C1705847 (UMLS CUI [1,1])
C0360714 (UMLS CUI [1,2])
Exception Antihypertensive Agents | Diuretics
Item
antihypertensives (diuretics not allowed)
boolean
C1705847 (UMLS CUI [1,1])
C0003364 (UMLS CUI [1,2])
C0012798 (UMLS CUI [2])
Exception Adrenergic alpha-Antagonists Benign prostatic hypertrophy
Item
alpha-blockers for benign prostate hypertrophy
boolean
C1705847 (UMLS CUI [1,1])
C0001641 (UMLS CUI [1,2])
C1704272 (UMLS CUI [1,3])
Exception Aspirin | Exception Ibuprofen | Exception Acetaminophen
Item
occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
boolean
C1705847 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0020740 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
Clinical Trial Eligibility Criteria Additional
Item
6. additional inclusion/exclusion criteria apply
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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