ID

38689

Beschrijving

Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control; ODM derived from: https://clinicaltrials.gov/show/NCT01438814

Link

https://clinicaltrials.gov/show/NCT01438814

Trefwoorden

Versies (1)
  1. 30-10-19 30-10-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

30 oktober 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01438814

Engels

Eligibility Diabetes Mellitus, Type 2 NCT01438814

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of type 2 diabetes mellitus (t2dm) prior to informed consent;
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
2. male and female patients on diet and exercise regimen who are drug naive, defined as absence of any oral antidiabetic therapy or insulin for 12 weeks prior to randomization
Beschrijving

Gender | Diet therapy | Exercise | Pharmaceutical Preparations Absent | Antidiabetics Oral Absent | Insulin Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C1527415
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0021641
UMLS CUI [6,2]
C0332197
3. glycosylated haemoglobin a1c (hba1c) >/= 7.0% (53 mmol/mol) to </= 10.0% (86 mmol/mol) at visit 1 (screening);
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
4. age>/=18 and </=80 years at visit 1(screening);
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. body mass index (bmi)</= 45kg/m2 at visit 1 (screening);
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
6. signed and dated written informed consent by date of visit 1 in accordance with good clinical practice (gcp) and local legislation
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled hyperglycaemia with a glucose level >240 mg/dl (13.3mmol/l) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (not on the same day);
Beschrijving

Hyperglycemia Uncontrolled | Glucose level | Status post Overnight Fasting

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0428548
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0439583
UMLS CUI [3,3]
C0015663
2. treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization
Beschrijving

Antidiabetics Oral | Insulin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0021641
3. acute coronary syndrome (non-stemi, stemi and unstable angina pectoris),stroke or transient ischemia attack (tia) within 3 months prior to informed consent;
Beschrijving

Acute Coronary Syndrome | Non-ST elevation (NSTEMI) myocardial infarction | ST segment elevation myocardial infarction | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C1561921
UMLS CUI [3]
C1536220
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
4. indication of liver disease/impaired hepatic function, defined by serum levels of either aspartate aminotransferase (alt or sgpt), alanine aminotransferase (ast or sgot), or alkaline phosphatase above 3 x upper limit of normal (uln) as determined at visit 1 and/or run-in phase,
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0023895
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0086565
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
UMLS CUI [5]
C0151849
5. impaired renal function, defined as egfr< 60ml/min (moderate or severe renal impairment, modification of diet in renal disease (mdrd) formula) as determined during screening or at run-in phase
Beschrijving

Renal Insufficiency | Estimated Glomerular Filtration Rate | Renal Insufficiency Moderate MDRD | Renal Insufficiency Severe MDRD

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C3811844
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0205081
UMLS CUI [3,3]
C3839656
UMLS CUI [4,1]
C1565489
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C3839656
6. bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malabsorption
Beschrijving

Bariatric Surgery | Gastrointestinal Surgical Procedure Inducing Malabsorption chronic

Datatype

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2,1]
C0524722
UMLS CUI [2,2]
C0205263
UMLS CUI [2,3]
C3714745
UMLS CUI [2,4]
C0205191
7. medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
Beschrijving

History of malignant neoplasm | Exception Basal cell carcinoma | Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0455471
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3]
C0920425
8. blood dyscrasia or any other disorders causing haemolysis or unstable red blood cell (eg. malaria, babesiosis, haemolytic anemia)
Beschrijving

Hematological Disease | Disease Causing Hemolysis | Disease Causing Erythrocytes Unstable | Malaria | Babesiosis | Anemia, Hemolytic

Datatype

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0019054
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0014792
UMLS CUI [3,4]
C0443343
UMLS CUI [4]
C0024530
UMLS CUI [5]
C0004576
UMLS CUI [6]
C0002878
9. known history of pancreatitis and chronic pancreatitis
Beschrijving

Pancreatitis | Pancreatitis, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
10. contraindications to metformin according to the local label
Beschrijving

Medical contraindication Metformin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
11. treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen etc) leading to unstable body weight
Beschrijving

Anti-Obesity Agents | Treatment Inducing Body Weight Unstable | Operative Surgical Procedures | Diet therapy Aggressive

Datatype

boolean

Alias
UMLS CUI [1]
C0376607
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205263
UMLS CUI [2,3]
C0005910
UMLS CUI [2,4]
C0443343
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C0012159
UMLS CUI [4,2]
C0580822
12. current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except t2dm
Beschrijving

Systemic steroids | Thyroid Hormones Dosage Change | Endocrine System Disease Uncontrolled | Exception Non-Insulin-Dependent Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2,1]
C0040135
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0392747
UMLS CUI [3,1]
C0014130
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0011860
13. pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:
Beschrijving

Premenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0232969
1. are nursing or pregnant or
Beschrijving

Breast Feeding | Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
2. 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 or who do not agree to continue contraception for at least 30 days after the last dose of study drug. acceptable methods of birth control include tubal ligation, transdermal patch, intra-uterine devices/systems(iuds/iuss), oral, implantable, or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomized partner.
Beschrijving

Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Tubal Ligation | Transdermal patch as birth control method | Intrauterine Devices | Contraceptives, Oral | Implantable subcutaneous contraceptive | Injectable contraception | Sexual Abstinence | Barrier Contraception Double | Partner had vasectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032976
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0520483
UMLS CUI [4]
C2135981
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0009905
UMLS CUI [7]
C3837145
UMLS CUI [8]
C1262153
UMLS CUI [9]
C0036899
UMLS CUI [10,1]
C0004764
UMLS CUI [10,2]
C0205173
UMLS CUI [11]
C0420842
14. alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
Beschrijving

Substance Use Disorder Interferes with Study Subject Participation Status | Condition Limiting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
15. participation in another trial with application of any investigational drug within 30 days prior to informed consent
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
16. any other clinical condition that would jeopardize patients safety while participating in this trial
Beschrijving

Study Subject Participation Status | Medical condition At risk Patient safety

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01438814

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. diagnosis of type 2 diabetes mellitus (t2dm) prior to informed consent;
boolean
C0011860 (UMLS CUI [1])
Gender | Diet therapy | Exercise | Pharmaceutical Preparations Absent | Antidiabetics Oral Absent | Insulin Absent
Item
2. male and female patients on diet and exercise regimen who are drug naive, defined as absence of any oral antidiabetic therapy or insulin for 12 weeks prior to randomization
boolean
C0079399 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0021641 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Hemoglobin A1c measurement
Item
3. glycosylated haemoglobin a1c (hba1c) >/= 7.0% (53 mmol/mol) to </= 10.0% (86 mmol/mol) at visit 1 (screening);
boolean
C0474680 (UMLS CUI [1])
Age
Item
4. age>/=18 and </=80 years at visit 1(screening);
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
5. body mass index (bmi)</= 45kg/m2 at visit 1 (screening);
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
6. signed and dated written informed consent by date of visit 1 in accordance with good clinical practice (gcp) and local legislation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyperglycemia Uncontrolled | Glucose level | Status post Overnight Fasting
Item
1. uncontrolled hyperglycaemia with a glucose level >240 mg/dl (13.3mmol/l) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (not on the same day);
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0439583 (UMLS CUI [3,2])
C0015663 (UMLS CUI [3,3])
Antidiabetics Oral | Insulin
Item
2. treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2])
Acute Coronary Syndrome | Non-ST elevation (NSTEMI) myocardial infarction | ST segment elevation myocardial infarction | Angina, Unstable | Cerebrovascular accident | Transient Ischemic Attack
Item
3. acute coronary syndrome (non-stemi, stemi and unstable angina pectoris),stroke or transient ischemia attack (tia) within 3 months prior to informed consent;
boolean
C0948089 (UMLS CUI [1])
C1561921 (UMLS CUI [2])
C1536220 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Indication Liver disease | Indication Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
4. indication of liver disease/impaired hepatic function, defined by serum levels of either aspartate aminotransferase (alt or sgpt), alanine aminotransferase (ast or sgot), or alkaline phosphatase above 3 x upper limit of normal (uln) as determined at visit 1 and/or run-in phase,
boolean
C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0086565 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
Renal Insufficiency | Estimated Glomerular Filtration Rate | Renal Insufficiency Moderate MDRD | Renal Insufficiency Severe MDRD
Item
5. impaired renal function, defined as egfr< 60ml/min (moderate or severe renal impairment, modification of diet in renal disease (mdrd) formula) as determined during screening or at run-in phase
boolean
C1565489 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C1565489 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C3839656 (UMLS CUI [3,3])
C1565489 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C3839656 (UMLS CUI [4,3])
Bariatric Surgery | Gastrointestinal Surgical Procedure Inducing Malabsorption chronic
Item
6. bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malabsorption
boolean
C1456587 (UMLS CUI [1])
C0524722 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C3714745 (UMLS CUI [2,3])
C0205191 (UMLS CUI [2,4])
History of malignant neoplasm | Exception Basal cell carcinoma | Cancer treatment
Item
7. medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
boolean
C0455471 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3])
Hematological Disease | Disease Causing Hemolysis | Disease Causing Erythrocytes Unstable | Malaria | Babesiosis | Anemia, Hemolytic
Item
8. blood dyscrasia or any other disorders causing haemolysis or unstable red blood cell (eg. malaria, babesiosis, haemolytic anemia)
boolean
C0018939 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0019054 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0014792 (UMLS CUI [3,3])
C0443343 (UMLS CUI [3,4])
C0024530 (UMLS CUI [4])
C0004576 (UMLS CUI [5])
C0002878 (UMLS CUI [6])
Pancreatitis | Pancreatitis, Chronic
Item
9. known history of pancreatitis and chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Medical contraindication Metformin
Item
10. contraindications to metformin according to the local label
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Anti-Obesity Agents | Treatment Inducing Body Weight Unstable | Operative Surgical Procedures | Diet therapy Aggressive
Item
11. treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen etc) leading to unstable body weight
boolean
C0376607 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C0005910 (UMLS CUI [2,3])
C0443343 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3])
C0012159 (UMLS CUI [4,1])
C0580822 (UMLS CUI [4,2])
Systemic steroids | Thyroid Hormones Dosage Change | Endocrine System Disease Uncontrolled | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
12. current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except t2dm
boolean
C2825233 (UMLS CUI [1])
C0040135 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0014130 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0011860 (UMLS CUI [4,2])
Premenopausal state
Item
13. pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:
boolean
C0232969 (UMLS CUI [1])
Breast Feeding | Pregnancy
Item
1. are nursing or pregnant or
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Tubal Ligation | Transdermal patch as birth control method | Intrauterine Devices | Contraceptives, Oral | Implantable subcutaneous contraceptive | Injectable contraception | Sexual Abstinence | Barrier Contraception Double | Partner had vasectomy
Item
2. 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 or who do not agree to continue contraception for at least 30 days after the last dose of study drug. acceptable methods of birth control include tubal ligation, transdermal patch, intra-uterine devices/systems(iuds/iuss), oral, implantable, or injectable contraceptives, complete sexual abstinence (if acceptable by local authorities), double barrier method and vasectomized partner.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0520483 (UMLS CUI [3])
C2135981 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C3837145 (UMLS CUI [7])
C1262153 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0004764 (UMLS CUI [10,1])
C0205173 (UMLS CUI [10,2])
C0420842 (UMLS CUI [11])
Substance Use Disorder Interferes with Study Subject Participation Status | Condition Limiting Protocol Compliance
Item
14. alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs
Item
15. participation in another trial with application of any investigational drug within 30 days prior to informed consent
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Study Subject Participation Status | Medical condition At risk Patient safety
Item
16. any other clinical condition that would jeopardize patients safety while participating in this trial
boolean
C2348568 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
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