ID

20666

Beschreibung

Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00328172

Link

https://clinicaltrials.gov/show/NCT00328172

Stichworte

Versionen (1)
  1. 09.03.17 09.03.17 -
Hochgeladen am

9. März 2017

DOI

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Eligibility Diabetes Mellitus, Type 2 NCT00328172

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00328172

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients with a diagnosis of type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Pharmaceutical Preparations naive | Oral hypoglycemic Quantity | Oral hypoglycemic Quantity Combined | rosiglitazone | pioglitazone | Antidiabetics Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0919936
UMLS CUI [5,1]
C0359086
UMLS CUI [5,2]
C1265611
UMLS CUI [6,1]
C0359086
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0205195
UMLS CUI [7]
C0289313
UMLS CUI [8]
C0071097
UMLS CUI [9,1]
C0935929
UMLS CUI [9,2]
C0205360
2. diagnosis of type 2 diabetes with duration of at least 3 months
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
3. glycosylated haemoglobin a1 (hba1c) of:
Beschreibung

Glycosylated hemoglobin A Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)
Beschreibung

Glycosylated hemoglobin A Percentage | Pharmaceutical Preparations naive | Washout Period | Antidiabetics Oral Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0919936
UMLS CUI [3]
C1710661
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C1265611
4. hba1c of 7.5%-10.0% at visit 3 (beginning of the 2-week placebo run-in period).
Beschreibung

Glycosylated hemoglobin A Percentage Patient Visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1512346
5. age >=21 and <=75 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. bmi (body mass index) >=25.0 and <=40 kg/m2.
Beschreibung

Body mass index

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
Beschreibung

Cardiovascular Diseases | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
2. impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
Beschreibung

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151849
3. renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
Beschreibung

Renal Insufficiency | Impaired renal function | Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3807752
UMLS CUI [3]
C0700225
4. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
Beschreibung

CNS disorder Interferes with Study Subject Participation Status | Epilepsy | Mental disorders | nervous system disorder | Cerebrovascular Disorders | Polyneuropathy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0007820
UMLS CUI [6]
C0152025
5. chronic or clinically relevant acute infections (e.g., human immunodeficiency virus, hepatitis)
Beschreibung

Communicable Diseases | Chronic infectious disease | HIV Infections | Hepatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0019158
6. history of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
Beschreibung

Hypersensitivity Interferes with Study Subject Participation Status | Hypersensitivity Investigational New Drug | Hypersensitivity Investigational New Drug Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013230
UMLS CUI [3,3]
C0015237
7. treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Beschreibung

rosiglitazone | pioglitazone

Datentyp

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0071097
8. treatment with insulin within 3 months prior to screening
Beschreibung

Insulin regime

Datentyp

boolean

Alias
UMLS CUI [1]
C0557978
9. alcohol or drug abuse within the last 3 months that would interfere with trial participation)
Beschreibung

Substance Use Disorder Interferes with Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
10. participation in another trial with an investigational drug within two months prior to administration or during the trial
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
11. fasting plasma glucose >240 mg/dl (= 13.3 mmol/l) at visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)
Beschreibung

Plasma fasting glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
12. pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
Beschreibung

Premenopausal | last menstrual period

Datentyp

boolean

Alias
UMLS CUI [1]
C0279752
UMLS CUI [2]
C0425932
1. are not surgically sterile,
Beschreibung

Female Sterilization Missing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015787
UMLS CUI [1,2]
C1705492
2. or are nursing or pregnant;
Beschreibung

Breast Feeding | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
3. or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. no exception will be made.
Beschreibung

Childbearing Potential Contraceptive methods Inadequate | transdermal patch | Intrauterine Devices | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | partner had vasectomy | Pregnancy Tests Periodic Disagree

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205412
UMLS CUI [2]
C2135981
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0009905
UMLS CUI [5]
C1657106
UMLS CUI [6]
C1656586
UMLS CUI [7]
C2035056
UMLS CUI [8,1]
C0032976
UMLS CUI [8,2]
C0332182
UMLS CUI [8,3]
C3641828
13. intolerance of metformin
Beschreibung

intolerance to Metformin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0025598
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00328172

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Pharmaceutical Preparations naive | Oral hypoglycemic Quantity | Oral hypoglycemic Quantity Combined | rosiglitazone | pioglitazone | Antidiabetics Stable
Item
1. male and female patients with a diagnosis of type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0919936 (UMLS CUI [4,2])
C0359086 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0359086 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0205195 (UMLS CUI [6,3])
C0289313 (UMLS CUI [7])
C0071097 (UMLS CUI [8])
C0935929 (UMLS CUI [9,1])
C0205360 (UMLS CUI [9,2])
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
2. diagnosis of type 2 diabetes with duration of at least 3 months
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Glycosylated hemoglobin A Percentage
Item
3. glycosylated haemoglobin a1 (hba1c) of:
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Glycosylated hemoglobin A Percentage | Pharmaceutical Preparations naive | Washout Period | Antidiabetics Oral Quantity
Item
7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C1710661 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Glycosylated hemoglobin A Percentage Patient Visit
Item
4. hba1c of 7.5%-10.0% at visit 3 (beginning of the 2-week placebo run-in period).
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1512346 (UMLS CUI [1,3])
Age
Item
5. age >=21 and <=75 years.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
6. bmi (body mass index) >=25.0 and <=40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
7. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and local legislation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
1. clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
2. impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Renal Insufficiency | Impaired renal function | Serum creatinine raised
Item
3. renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
boolean
C1565489 (UMLS CUI [1])
C3807752 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
CNS disorder Interferes with Study Subject Participation Status | Epilepsy | Mental disorders | nervous system disorder | Cerebrovascular Disorders | Polyneuropathy
Item
4. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
boolean
C0007682 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0014544 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0007820 (UMLS CUI [5])
C0152025 (UMLS CUI [6])
Communicable Diseases | Chronic infectious disease | HIV Infections | Hepatitis
Item
5. chronic or clinically relevant acute infections (e.g., human immunodeficiency virus, hepatitis)
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
Hypersensitivity Interferes with Study Subject Participation Status | Hypersensitivity Investigational New Drug | Hypersensitivity Investigational New Drug Excipient
Item
6. history of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
boolean
C0020517 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
rosiglitazone | pioglitazone
Item
7. treatment with rosiglitazone or pioglitazone within 6 months prior to screening
boolean
C0289313 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
Insulin regime
Item
8. treatment with insulin within 3 months prior to screening
boolean
C0557978 (UMLS CUI [1])
Substance Use Disorder Interferes with Study Subject Participation Status
Item
9. alcohol or drug abuse within the last 3 months that would interfere with trial participation)
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
10. participation in another trial with an investigational drug within two months prior to administration or during the trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
11. fasting plasma glucose >240 mg/dl (= 13.3 mmol/l) at visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)
boolean
C0583513 (UMLS CUI [1])
Premenopausal | last menstrual period
Item
12. pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
boolean
C0279752 (UMLS CUI [1])
C0425932 (UMLS CUI [2])
Female Sterilization Missing
Item
1. are not surgically sterile,
boolean
C0015787 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
2. or are nursing or pregnant;
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Inadequate | transdermal patch | Intrauterine Devices | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | partner had vasectomy | Pregnancy Tests Periodic Disagree
Item
3. or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. no exception will be made.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C2135981 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0009905 (UMLS CUI [4])
C1657106 (UMLS CUI [5])
C1656586 (UMLS CUI [6])
C2035056 (UMLS CUI [7])
C0032976 (UMLS CUI [8,1])
C0332182 (UMLS CUI [8,2])
C3641828 (UMLS CUI [8,3])
intolerance to Metformin
Item
13. intolerance of metformin
boolean
C1744706 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
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