ID

42902

Beschrijving

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets; ODM derived from: https://clinicaltrials.gov/show/NCT01924767

Link

https://clinicaltrials.gov/show/NCT01924767

Trefwoorden

Versies (2)
  1. 07-03-18 07-03-18 -
  2. 17-09-21 17-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01924767

Engels

Eligibility Diabetes Mellitus, Type 2 NCT01924767

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.
Beschrijving

Gender | Postmenopausal state | Hysterectomy | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Antidiabetics Oral Quantity | Exception Thiazolidinediones

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0011860
UMLS CUI [5]
C0012159
UMLS CUI [6]
C0015259
UMLS CUI [7,1]
C0935929
UMLS CUI [7,2]
C1527415
UMLS CUI [7,3]
C1265611
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C1257987
2. glycosylated haemoglobin a1 (hba1c) £ 8.5 % at screening.
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
3. age >21 and age <70 years (male and hysterectomised female patients) age >60 and age <70 years (postmenopausal female patients)
Beschrijving

Age | Gender | Hysterectomy | Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0232970
4. body mass index (bmi) >18.5 and <40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
5. signed and dated written informed consent prior to admission to the study in accordance with gcp and the local legislation
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)
Beschrijving

Antidiabetics | Insulin | Thiazolidinediones | Oral hypoglycemic Quantity

Datatype

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 > 240 mg/dl (>13.3 mmol/l) on two consecutive days during washout.
Beschrijving

Fasting blood glucose measurement Quantity Washout Period

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428568
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1710661
3. glycosylated haemoglobin a1 (hba1c) >8.5% at screening
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
4. clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011860
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0020473
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0020538
UMLS CUI [4,3]
C1522326
any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)
Beschrijving

Complications of Diabetes Mellitus Late stage | Retinal Diseases | Polyneuropathy | Nervous system; disorder, vegetative | Diabetic Foot

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0544467
UMLS CUI [2]
C0035309
UMLS CUI [3]
C0152025
UMLS CUI [4]
C1411263
UMLS CUI [5]
C0206172
renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²)
Beschrijving

Renal Insufficiency | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0373595
cardiac insufficiency nyha ii-iv, myocardial infarction, other known cardiovascular diseases including hypertension > 160/95mmhg (measured at training visit and each of the timepoints of day -1), stroke and tia (transistoric ischaemic attack)
Beschrijving

Heart insuffiency New York Heart Association Classification | Myocardial Infarction | Cardiovascular Diseases | Hypertensive disease | Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392173
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0020538
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
neurological disorders (such as epilepsy) or psychiatric disorders
Beschrijving

Nervous system disorder | Epilepsy | Mental disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0004936
acute or relevant chronic infections (e.g. hiv, repeated urogenital infections)
Beschrijving

Communicable Diseases | Chronic infectious disease | HIV Infections | Genitourinary tract infection Repeated

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0019693
UMLS CUI [4,1]
C1279264
UMLS CUI [4,2]
C0205341
any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0035204
UMLS CUI [4]
C0014130
UMLS CUI [5]
C0021053
5. history of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Beschrijving

Hypersensitivity | Drug Allergy | Hypersensitivity Pharmaceutical Excipient

Datatype

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0013182
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0015237
6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 ms)
Beschrijving

Prolonged QT interval | Prolonged QTc interval

Datatype

boolean

Alias
UMLS CUI [1]
C0151878
UMLS CUI [2]
C1560305
7. a history of additional risk factors for tdp (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)
Beschrijving

Risk factors Additional Torsades de Pointes | Heart failure | Hypokalemia | Family history of sudden death

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0040479
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0020621
UMLS CUI [4]
C2315244
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01924767

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Postmenopausal state | Hysterectomy | Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Antidiabetics Oral Quantity | Exception Thiazolidinediones
Item
1. male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
C0012159 (UMLS CUI [5])
C0015259 (UMLS CUI [6])
C0935929 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C1257987 (UMLS CUI [8,2])
Glucohemoglobin measurement
Item
2. glycosylated haemoglobin a1 (hba1c) £ 8.5 % at screening.
boolean
C0202054 (UMLS CUI [1])
Age | Gender | Hysterectomy | Postmenopausal state
Item
3. age >21 and age <70 years (male and hysterectomised female patients) age >60 and age <70 years (postmenopausal female patients)
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
Body mass index
Item
4. body mass index (bmi) >18.5 and <40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
5. signed and dated written informed consent prior to admission to the study in accordance with 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 or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)
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 Quantity Washout Period
Item
2. fasted blood glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days during washout.
boolean
C0428568 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1710661 (UMLS CUI [1,3])
Glucohemoglobin measurement
Item
3. glycosylated haemoglobin a1 (hba1c) >8.5% at screening
boolean
C0202054 (UMLS CUI [1])
Comorbidity | Exception Non-Insulin-Dependent Diabetes Mellitus | Exception Hyperlipidemia | Exception Hypertensive disease Treated
Item
4. clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
boolean
C0009488 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0020473 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Complications of Diabetes Mellitus Late stage | Retinal Diseases | Polyneuropathy | Nervous system; disorder, vegetative | Diabetic Foot
Item
any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)
boolean
C0342257 (UMLS CUI [1,1])
C0544467 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2])
C0152025 (UMLS CUI [3])
C1411263 (UMLS CUI [4])
C0206172 (UMLS CUI [5])
Renal Insufficiency | Creatinine clearance measurement
Item
renal insufficiency (calculated creatinine clearance < 80 ml/min/1.73m²)
boolean
C1565489 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Heart insuffiency New York Heart Association Classification | Myocardial Infarction | Cardiovascular Diseases | Hypertensive disease | Cerebrovascular accident | Transient Ischemic Attack
Item
cardiac insufficiency nyha ii-iv, myocardial infarction, other known cardiovascular diseases including hypertension > 160/95mmhg (measured at training visit and each of the timepoints of day -1), stroke and tia (transistoric ischaemic attack)
boolean
C0392173 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
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])
Communicable Diseases | Chronic infectious disease | HIV Infections | Genitourinary tract infection Repeated
Item
acute or relevant chronic infections (e.g. hiv, repeated urogenital infections)
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0019693 (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])
Hypersensitivity | Drug Allergy | Hypersensitivity Pharmaceutical Excipient
Item
5. history of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
boolean
C0020517 (UMLS CUI [1])
C0013182 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
Prolonged QT interval | Prolonged QTc interval
Item
6. a marked baseline prolongation of qt/qtc interval (e.g., repeated demonstration of a qtc interval >450 ms)
boolean
C0151878 (UMLS CUI [1])
C1560305 (UMLS CUI [2])
Risk factors Additional Torsades de Pointes | Heart failure | Hypokalemia | Family history of sudden death
Item
7. a history of additional risk factors for tdp (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)
boolean
C0035648 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2])
C0020621 (UMLS CUI [3])
C2315244 (UMLS CUI [4])
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