ID

38770

Beschrijving

Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01708902

Link

https://clinicaltrials.gov/show/NCT01708902

Trefwoorden

Versies (1)
  1. 02-11-19 02-11-19 -
Houder van rechten

See clinicaltrials.gov

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2 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01708902

Engels

Eligibility Diabetes Mellitus, Type 2 NCT01708902

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-naïve
Beschrijving

Gender | Diet therapy | Exercise | Pharmaceutical Preparations 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
3. glycosylated haemoglobin a1c (hba1c) at v1a >/=7.5 %<11% for main group and hba1c >/= 11.0 % for the additional parallel group
Beschrijving

Hemoglobin A1c measurement | Group Main | Group Additional

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C1542147
UMLS CUI [3,1]
C0441833
UMLS CUI [3,2]
C1524062
4. age >/= 18 and </= 80 years at visit 1a (screening)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. body mass index(bmi)</ = 40 kg/m2 at visit 1a (screening)
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
6. signed and dated written informed consent by date of visit 1a 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 required for rescue medication during placebo run-in phase
Beschrijving

Hyperglycemia Uncontrolled | Pharmaceutical Preparations Required

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1514873
2. in main group, the patients with investigational medicinal product(imp) compliance < 80 % or >120 % during 2 weeks placebo run in period
Beschrijving

Compliance Percentage Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0013230
3. acute coronary syndrome stroke or transient ischaemic attack (tia) within 3 months prior to randomisation
Beschrijving

Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
4. impaired hepatic function, defined by serum levels of either alanine aminotransferase(alt) ,aspartate aminotransferase(ast), or alkaline phosphatase (ap) above 3 x upper limit of normal (uln) ,or total bilirubin above 1.5 x uln as determined at visit 1a
Beschrijving

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151849
UMLS CUI [5]
C1278039
5. known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo
Beschrijving

Hypersensitivity Linagliptin | Hypersensitivity Linagliptin Excipient | Metformin allergy | Hypersensitivity Placebo

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2746078
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2746078
UMLS CUI [2,3]
C0015237
UMLS CUI [3]
C0571648
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0032042
6. treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening
Beschrijving

Anti-Obesity Agents | Therapeutic procedure Any

Datatype

boolean

Alias
UMLS CUI [1]
C0376607
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1552551
7. alcohol or drug abuse within the 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 in the opinion of the investigator.
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
8. concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.
Beschrijving

Study Subject Participation Status | Therapies, Investigational

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
9. pre-menopausal women (last menstruation </= 1 year prior to informed consent) who are nursing or pregnant 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
Beschrijving

Premenopausal state | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032961
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
10. current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
Beschrijving

Systemic steroids | Thyroid Hormones Dose Change

Datatype

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2,1]
C0040135
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0392747
11. renal failure or renal impairment at visit 1a (screening) with an estimated glomerular filtration rate(egfr) < 60 ml/min
Beschrijving

Kidney Failure | Renal Insufficiency | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C1565489
UMLS CUI [3]
C3811844
12. bariatric surgery within the past two years and other gastrointestinal surgeries that induce 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
13. dehydration by clinical judgement of the investigator
Beschrijving

Dehydration

Datatype

boolean

Alias
UMLS CUI [1]
C0011175
14. clinical detected unstable or acute congestive heart failure
Beschrijving

Congestive heart failure Unstable | Congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0018802
15. acute or chronic metabolic acidosis (present in patient history)
Beschrijving

Metabolic acidosis | Chronic metabolic acidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0740749
16. hereditary galactose intolerance
Beschrijving

Galactosemia Hereditary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016952
UMLS CUI [1,2]
C0439660
17. known history of pancreatitis and chronic pancreatitis
Beschrijving

History of pancreatitis | Pancreatitis, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C3887021
UMLS CUI [2]
C0149521
18. medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years.
Beschrijving

Cancer History | Exception Basal cell carcinoma | Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C1512706
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3]
C0920425
19. any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator
Beschrijving

Study Subject Participation Status | Other 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 NCT01708902

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
Item
2. male and female patients on diet and exercise regimen who are drug-naïve
boolean
C0079399 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hemoglobin A1c measurement | Group Main | Group Additional
Item
3. glycosylated haemoglobin a1c (hba1c) at v1a >/=7.5 %<11% for main group and hba1c >/= 11.0 % for the additional parallel group
boolean
C0474680 (UMLS CUI [1])
C0441833 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C0441833 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
Age
Item
4. age >/= 18 and </= 80 years at visit 1a (screening)
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
5. body mass index(bmi)</ = 40 kg/m2 at visit 1a (screening)
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
6. signed and dated written informed consent by date of visit 1a in accordance with good clinical practice(gcp) and local legislation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyperglycemia Uncontrolled | Pharmaceutical Preparations Required
Item
1. uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Compliance Percentage Investigational New Drugs
Item
2. in main group, the patients with investigational medicinal product(imp) compliance < 80 % or >120 % during 2 weeks placebo run in period
boolean
C1321605 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack
Item
3. acute coronary syndrome stroke or transient ischaemic attack (tia) within 3 months prior to randomisation
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Serum total bilirubin measurement
Item
4. impaired hepatic function, defined by serum levels of either alanine aminotransferase(alt) ,aspartate aminotransferase(ast), or alkaline phosphatase (ap) above 3 x upper limit of normal (uln) ,or total bilirubin above 1.5 x uln as determined at visit 1a
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Hypersensitivity Linagliptin | Hypersensitivity Linagliptin Excipient | Metformin allergy | Hypersensitivity Placebo
Item
5. known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo
boolean
C0020517 (UMLS CUI [1,1])
C2746078 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2746078 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0571648 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0032042 (UMLS CUI [4,2])
Anti-Obesity Agents | Therapeutic procedure Any
Item
6. treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening
boolean
C0376607 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Substance Use Disorder Interferes with Study Subject Participation Status | Condition Limiting Protocol Compliance
Item
7. alcohol or drug abuse within the 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 in the opinion of the investigator.
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 | Therapies, Investigational
Item
8. concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Premenopausal state | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
9. pre-menopausal women (last menstruation </= 1 year prior to informed consent) who are nursing or pregnant 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
boolean
C0232969 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Systemic steroids | Thyroid Hormones Dose Change
Item
10. current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
boolean
C2825233 (UMLS CUI [1])
C0040135 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
Kidney Failure | Renal Insufficiency | Estimated Glomerular Filtration Rate
Item
11. renal failure or renal impairment at visit 1a (screening) with an estimated glomerular filtration rate(egfr) < 60 ml/min
boolean
C0035078 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C3811844 (UMLS CUI [3])
Bariatric Surgery | Gastrointestinal Surgical Procedure Inducing Malabsorption chronic
Item
12. bariatric surgery within the past two years and other gastrointestinal surgeries that induce 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])
Dehydration
Item
13. dehydration by clinical judgement of the investigator
boolean
C0011175 (UMLS CUI [1])
Congestive heart failure Unstable | Congestive heart failure
Item
14. clinical detected unstable or acute congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
Metabolic acidosis | Chronic metabolic acidosis
Item
15. acute or chronic metabolic acidosis (present in patient history)
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
Galactosemia Hereditary
Item
16. hereditary galactose intolerance
boolean
C0016952 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
History of pancreatitis | Pancreatitis, Chronic
Item
17. known history of pancreatitis and chronic pancreatitis
boolean
C3887021 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Cancer History | Exception Basal cell carcinoma | Cancer treatment
Item
18. medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years.
boolean
C1512706 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3])
Study Subject Participation Status | Other medical condition At risk Patient safety
Item
19. any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator
boolean
C2348568 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
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