ID

29106

Beskrivning

BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00602472

Länk

https://clinicaltrials.gov/show/NCT00602472

Nyckelord

Versioner (1)
  1. 2018-02-25 2018-02-25 -
Rättsinnehavare

See clinicaltrials.gov

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25 februari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00602472

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00602472

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable unchanged | Sulfonylurea Dose Stable unchanged | Metformin U/day | Sulfonylurea Maximum Tolerated Dose

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0442739
UMLS CUI [3,1]
C0038766
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0442739
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0038766
UMLS CUI [5,2]
C0752079
2. glycosylated haemoglobin a1 (hba1c) >/= 7.0 and </= 10.0% at the screening visit 1a and at visit 2 (start of placebo run-in phase)
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
3. age >/= 18 and </= 80 years at visit 1a (screening)
Beskrivning

Age

Datatyp

boolean

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

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
5. signed and dated written informed consent, at the latest by the date of visit 1a, in accordance with gcp and local legislation *patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. myocardial infarction, stroke or tia (transient ischaemic attack) within 6 months prior to the date of informed consent
Beskrivning

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
2. impaired hepatic function, defined by serum levels of either alanine transaminase (alt/sgpt), aspartase transaminase (ast/sgot), or alkaline phosphatase (alp) above 3 times the upper limit of normal (uln), as determined at visit 1a
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0750857
3. renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at visit 1a
Beskrivning

Kidney Failure | Renal Insufficiency | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0201976
4. treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
Beskrivning

rosiglitazone | pioglitazone

Datatyp

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0071097
5. treatment with glp-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
Beskrivning

GLP-1 Analogue | exenatide

Datatyp

boolean

Alias
UMLS CUI [1]
C3273809
UMLS CUI [2]
C0167117
6. treatment with insulin within 3 months prior to the date of informed consent
Beskrivning

Insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0021641
7. treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
Beskrivning

Anti-Obesity Agents | sibutramine | rimonabant | orlistat

Datatyp

boolean

Alias
UMLS CUI [1]
C0376607
UMLS CUI [2]
C0074493
UMLS CUI [3]
C1142933
UMLS CUI [4]
C0076275
8. current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
Beskrivning

Systemic steroids | Thyroid Hormones Medication dose changed

Datatyp

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2,1]
C0040135
UMLS CUI [2,2]
C1608430
9. pre-menopausal women (last menstruation </= 1 year prior to the date of informed consent) who:
Beskrivning

Premenopausal state | Timepoint Menstruation Last

Datatyp

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2,1]
C2348792
UMLS CUI [2,2]
C0025344
UMLS CUI [2,3]
C1517741
are nursing or pregnant
Beskrivning

Breast Feeding | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
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 periodic pregnancy testing during their participation in the trial. acceptable methods of birth control include transdermal patch, intra uterine devices/systems (iuds/iuss), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. no exception will be made.
Beskrivning

Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Periodic Refused | Transdermal contraception | Intrauterine Devices | Contraceptives, Oral | Contraceptive methods Implants | Contraceptive methods Injectables | Sexual Abstinence | Partner had vasectomy

Datatyp

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]
C0332182
UMLS CUI [2,4]
C1705116
UMLS CUI [3]
C1168146
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0009905
UMLS CUI [6,1]
C0700589
UMLS CUI [6,2]
C0021102
UMLS CUI [7,1]
C0700589
UMLS CUI [7,2]
C0086466
UMLS CUI [8]
C0036899
UMLS CUI [9]
C2035056
10. known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient | Hypersensitivity Clinical Trial Therapeutic procedure | Metformin allergy | Sulfonylurea allergy | Allergy to sulfonamides

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0008976
UMLS CUI [3,3]
C0087111
UMLS CUI [4]
C0571648
UMLS CUI [5]
C0571636
UMLS CUI [6]
C0038757
11. dehydration (as confirmed by the investigators clinical opinion)
Beskrivning

Dehydration

Datatyp

boolean

Alias
UMLS CUI [1]
C0011175
12. current acute or chronic metabolic acidosis
Beskrivning

Metabolic acidosis | Chronic metabolic acidosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0740749
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00602472

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable unchanged | Sulfonylurea Dose Stable unchanged | Metformin U/day | Sulfonylurea Maximum Tolerated Dose
Item
1. male and female patients with a diagnosis of type 2 diabetes mellitus, currently treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0442739 (UMLS CUI [2,4])
C0038766 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0442739 (UMLS CUI [3,4])
C0025598 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0038766 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
Glucohemoglobin measurement
Item
2. glycosylated haemoglobin a1 (hba1c) >/= 7.0 and </= 10.0% at the screening visit 1a and at visit 2 (start of placebo run-in phase)
boolean
C0202054 (UMLS CUI [1])
Age
Item
3. age >/= 18 and </= 80 years at visit 1a (screening)
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
4. bmi (body mass index) </= 40 kg/m2 at visit 1a (screening)
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
5. signed and dated written informed consent, at the latest by the date of visit 1a, in accordance with gcp and local legislation *patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
1. myocardial infarction, stroke or tia (transient ischaemic attack) within 6 months prior to the date of informed consent
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase serum increased
Item
2. impaired hepatic function, defined by serum levels of either alanine transaminase (alt/sgpt), aspartase transaminase (ast/sgot), or alkaline phosphatase (alp) above 3 times the upper limit of normal (uln), as determined at visit 1a
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0750857 (UMLS CUI [4])
Kidney Failure | Renal Insufficiency | Creatinine measurement, serum
Item
3. renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at visit 1a
boolean
C0035078 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
rosiglitazone | pioglitazone
Item
4. treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
boolean
C0289313 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
GLP-1 Analogue | exenatide
Item
5. treatment with glp-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
boolean
C3273809 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
Insulin
Item
6. treatment with insulin within 3 months prior to the date of informed consent
boolean
C0021641 (UMLS CUI [1])
Anti-Obesity Agents | sibutramine | rimonabant | orlistat
Item
7. treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
boolean
C0376607 (UMLS CUI [1])
C0074493 (UMLS CUI [2])
C1142933 (UMLS CUI [3])
C0076275 (UMLS CUI [4])
Systemic steroids | Thyroid Hormones Medication dose changed
Item
8. current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
boolean
C2825233 (UMLS CUI [1])
C0040135 (UMLS CUI [2,1])
C1608430 (UMLS CUI [2,2])
Premenopausal state | Timepoint Menstruation Last
Item
9. pre-menopausal women (last menstruation </= 1 year prior to the date of informed consent) who:
boolean
C0232969 (UMLS CUI [1])
C2348792 (UMLS CUI [2,1])
C0025344 (UMLS CUI [2,2])
C1517741 (UMLS CUI [2,3])
Breast Feeding | Pregnancy
Item
are nursing or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Periodic Refused | Transdermal contraception | Intrauterine Devices | Contraceptives, Oral | Contraceptive methods Implants | Contraceptive methods Injectables | Sexual Abstinence | Partner had vasectomy
Item
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 periodic pregnancy testing during their participation in the trial. acceptable methods of birth control include transdermal patch, intra uterine devices/systems (iuds/iuss), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. no exception will be made.
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])
C0332182 (UMLS CUI [2,3])
C1705116 (UMLS CUI [2,4])
C1168146 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C0700589 (UMLS CUI [6,1])
C0021102 (UMLS CUI [6,2])
C0700589 (UMLS CUI [7,1])
C0086466 (UMLS CUI [7,2])
C0036899 (UMLS CUI [8])
C2035056 (UMLS CUI [9])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient | Hypersensitivity Clinical Trial Therapeutic procedure | Metformin allergy | Sulfonylurea allergy | Allergy to sulfonamides
Item
10. known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0571648 (UMLS CUI [4])
C0571636 (UMLS CUI [5])
C0038757 (UMLS CUI [6])
Dehydration
Item
11. dehydration (as confirmed by the investigators clinical opinion)
boolean
C0011175 (UMLS CUI [1])
Metabolic acidosis | Chronic metabolic acidosis
Item
12. current acute or chronic metabolic acidosis
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
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