ID

38821

Beschrijving

Safety and Tolerability, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Three Doses of BI 187004 Over 28 Days in Patients With Type 2 Diabetes Mellitus With and Without Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT02150824

Link

https://clinicaltrials.gov/show/NCT02150824

Trefwoorden

Versies (1)
  1. 06-11-19 06-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02150824

Engels

Eligibility Diabetes Mellitus, Type 2 NCT02150824

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or postmenopausal or hysterectomised female patients with diagnosis of type 2 diabetes mellitus (t2dm) before informed consent
Beschrijving

Gender | Postmenopausal state | Hysterectomy | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0011860
2. to be eligible for arm 1
Beschrijving

Eligible Arm Number

Datatype

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1522541
UMLS CUI [1,3]
C0237753
1. oral antidiabetic mono-therapy for the last 12 weeks prior to informed consent and glycosylated haemoglobin (hba1c) >= 6.5% and <= 8.5% at visit 1a
Beschrijving

Antidiabetics Oral | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0474680
2. therapy-naïve patients or no antidiabetic treatment within 4 weeks prior to informed consent and hba1c >= 7.0% and <= 9.5% at visit 1a.
Beschrijving

Therapy naive | Diabetes Therapy Absent | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C3274787
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0474680
3. to be eligible for arm 2:
Beschrijving

Eligible Arm Number

Datatype

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C1522541
UMLS CUI [1,3]
C0237753
a. antidiabetic treatment with metformin with an unchanged daily dose for 12 weeks prior to informed consent and patient´s willingness to keep this therapy stable during the course of the trial and hba1c >= 7.0% and <= 9.5% at visit 1a
Beschrijving

Diabetes Therapy | Metformin Dose Daily | Metformin Dose unchanged | Therapy Stable Willing

Datatype

boolean

Alias
UMLS CUI [1]
C3274787
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0332173
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0442739
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205360
UMLS CUI [4,3]
C0600109
4. age >=18 and <=80 years for female hysterectomised and male patients at visit 1a
Beschrijving

Age | Gender | Hysterectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0020699
5. age >=55 and <=80 years for female postmenopausal (defined by the absence of menses for at least 2 years) patients at visit 1a
Beschrijving

Age | Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
6. body mass index (bmi) >= 28 and <= 40 kg/m2 at visit 1a
Beschrijving

Body mass index

Datatype

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 the local legislation
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. treatment with a non-oral antidiabetic therapy or with more than one oral antidiabetic medication within 12 weeks prior to visit 1a.
Beschrijving

Diabetes Therapy | Exception Antidiabetics Oral | Antidiabetics Oral Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C3274787
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0935929
UMLS CUI [2,3]
C1527415
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C1265611
2. fasted plasma glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days after screening (visit 1a) confirmed by a fasted laboratory blood glucose test until first administration of the trial drug
Beschrijving

Plasma fasting glucose measurement Confirmed by Fasted Laboratory blood glucose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0583513
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C0430031
UMLS CUI [1,4]
C0015663
3. any laboratory value more than 3 times above upper limit normal (uln) at screening (visit 1a) or any other laboratory value outside the reference range and clinically relevant in the investigator judgment
Beschrijving

Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0438215
4. any known clinically relevant concomitant diseases or chronic diseases other than type 2 diabetes, hyperlipidaemia or medically treated hypertension
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0008679
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011860
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0020473
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0020538
UMLS CUI [5,3]
C1522326
5. medical history of cancer or treatment for cancer in the last five years prior to the visit 1a.
Beschrijving

History of cancer | Cancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0455471
UMLS CUI [2]
C0920425
6. history of cushing syndrome, addison´s disease, congenital adrenal hyperplasia or polycystic ovary syndrome
Beschrijving

Cushing Syndrome | Addison Disease | Congenital adrenal hyperplasia | Polycystic Ovary Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0010481
UMLS CUI [2]
C0001403
UMLS CUI [3]
C0001627
UMLS CUI [4]
C0032460
7. treatment with systemic, inhalatory or ophthalmologic steroids within 12 weeks prior to first administration of the trial drug.
Beschrijving

Systemic steroids | inhaled steroids | Steroids Ophthalmologic

Datatype

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C2065041
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0205481
8. treatment compliance during the run-in period is outside the per protocol range defined range, between 80%-120% treatment compliance.
Beschrijving

Treatment Compliance Abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C0205161
9. use of any other concomitant medication within 5 half-lives before the first administration of the trial drug except for allowed co-medication.
Beschrijving

Pharmaceutical Preparation concomitant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521115
10. surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to informed consent or blood donation (more than 100 ml) within four weeks prior to first administration of study medication or planned during the trial
Beschrijving

Blood Loss Amount Due to Operative Surgical Procedures | Blood Loss Amount Due to Trauma | Blood Donation Amount | Blood Donation Amount Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C3163616
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0543467
UMLS CUI [2,1]
C3163616
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C3714660
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0005794
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C1301732
11. any other medical condition that would interfere with trial participation based on investigator´s judgement or any on-going clinical condition that would jeopardize patient´s or site personnel´s safety or study compliance based on investigator judgement. smoking habits interfering with hospitalization. patients not willing to abstain from alcoholic beverages during inpatient visits
Beschrijving

Other medical condition Interferes with Study Subject Participation Status | Other medical condition At risk Patient safety | Other medical condition At risk Research Personnel | Other medical condition At risk Protocol Compliance | Smoking Habit Interferes with Hospitalization | Alcohol Abstinence Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0035173
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C4505437
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0019993
UMLS CUI [6,1]
C0678274
UMLS CUI [6,2]
C0558080
12. male patients not willing to use adequate contraception (sexual abstinence, condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake
Beschrijving

Gender Contraceptive methods Unwilling | Sexual Abstinence | Condoms, Male | Spermatocidal Agents | Oral Contraceptives Partner Female | Sterilization | Intrauterine Devices

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2]
C0036899
UMLS CUI [3]
C0009653
UMLS CUI [4]
C0037862
UMLS CUI [5,1]
C0009905
UMLS CUI [5,2]
C0682323
UMLS CUI [5,3]
C0086287
UMLS CUI [6]
C0038288
UMLS CUI [7]
C0021900
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02150824

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
Item
1. male or postmenopausal or hysterectomised female patients with diagnosis of type 2 diabetes mellitus (t2dm) before informed consent
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
Eligible Arm Number
Item
2. to be eligible for arm 1
boolean
C1548635 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Antidiabetics Oral | Hemoglobin A1c measurement
Item
1. oral antidiabetic mono-therapy for the last 12 weeks prior to informed consent and glycosylated haemoglobin (hba1c) >= 6.5% and <= 8.5% at visit 1a
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Therapy naive | Diabetes Therapy Absent | Hemoglobin A1c measurement
Item
2. therapy-naïve patients or no antidiabetic treatment within 4 weeks prior to informed consent and hba1c >= 7.0% and <= 9.5% at visit 1a.
boolean
C0919936 (UMLS CUI [1])
C3274787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0474680 (UMLS CUI [3])
Eligible Arm Number
Item
3. to be eligible for arm 2:
boolean
C1548635 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Diabetes Therapy | Metformin Dose Daily | Metformin Dose unchanged | Therapy Stable Willing
Item
a. antidiabetic treatment with metformin with an unchanged daily dose for 12 weeks prior to informed consent and patient´s willingness to keep this therapy stable during the course of the trial and hba1c >= 7.0% and <= 9.5% at visit 1a
boolean
C3274787 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
C0600109 (UMLS CUI [4,3])
Age | Gender | Hysterectomy
Item
4. age >=18 and <=80 years for female hysterectomised and male patients at visit 1a
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
Age | Postmenopausal state
Item
5. age >=55 and <=80 years for female postmenopausal (defined by the absence of menses for at least 2 years) patients at visit 1a
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Body mass index
Item
6. body mass index (bmi) >= 28 and <= 40 kg/m2 at visit 1a
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 the local legislation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Therapy | Exception Antidiabetics Oral | Antidiabetics Oral Quantity
Item
1. treatment with a non-oral antidiabetic therapy or with more than one oral antidiabetic medication within 12 weeks prior to visit 1a.
boolean
C3274787 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Plasma fasting glucose measurement Confirmed by Fasted Laboratory blood glucose
Item
2. fasted plasma glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days after screening (visit 1a) confirmed by a fasted laboratory blood glucose test until first administration of the trial drug
boolean
C0583513 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0430031 (UMLS CUI [1,3])
C0015663 (UMLS CUI [1,4])
Laboratory test result abnormal
Item
3. any laboratory value more than 3 times above upper limit normal (uln) at screening (visit 1a) or any other laboratory value outside the reference range and clinically relevant in the investigator judgment
boolean
C0438215 (UMLS CUI [1])
Comorbidity | Chronic disease | Exception Non-Insulin-Dependent Diabetes Mellitus | Exception Hyperlipidemia | Exception Hypertensive disease Treated
Item
4. any known clinically relevant concomitant diseases or chronic diseases other than type 2 diabetes, hyperlipidaemia or medically treated hypertension
boolean
C0009488 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0011860 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0020473 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0020538 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
History of cancer | Cancer treatment
Item
5. medical history of cancer or treatment for cancer in the last five years prior to the visit 1a.
boolean
C0455471 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
Cushing Syndrome | Addison Disease | Congenital adrenal hyperplasia | Polycystic Ovary Syndrome
Item
6. history of cushing syndrome, addison´s disease, congenital adrenal hyperplasia or polycystic ovary syndrome
boolean
C0010481 (UMLS CUI [1])
C0001403 (UMLS CUI [2])
C0001627 (UMLS CUI [3])
C0032460 (UMLS CUI [4])
Systemic steroids | inhaled steroids | Steroids Ophthalmologic
Item
7. treatment with systemic, inhalatory or ophthalmologic steroids within 12 weeks prior to first administration of the trial drug.
boolean
C2825233 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
C0038317 (UMLS CUI [3,1])
C0205481 (UMLS CUI [3,2])
Treatment Compliance Abnormal
Item
8. treatment compliance during the run-in period is outside the per protocol range defined range, between 80%-120% treatment compliance.
boolean
C4319828 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Pharmaceutical Preparation concomitant
Item
9. use of any other concomitant medication within 5 half-lives before the first administration of the trial drug except for allowed co-medication.
boolean
C0013227 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
Blood Loss Amount Due to Operative Surgical Procedures | Blood Loss Amount Due to Trauma | Blood Donation Amount | Blood Donation Amount Planned
Item
10. surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to informed consent or blood donation (more than 100 ml) within four weeks prior to first administration of study medication or planned during the trial
boolean
C3163616 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C3163616 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C3714660 (UMLS CUI [2,4])
C0005794 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0005794 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Other medical condition Interferes with Study Subject Participation Status | Other medical condition At risk Patient safety | Other medical condition At risk Research Personnel | Other medical condition At risk Protocol Compliance | Smoking Habit Interferes with Hospitalization | Alcohol Abstinence Unwilling
Item
11. any other medical condition that would interfere with trial participation based on investigator´s judgement or any on-going clinical condition that would jeopardize patient´s or site personnel´s safety or study compliance based on investigator judgement. smoking habits interfering with hospitalization. patients not willing to abstain from alcoholic beverages during inpatient visits
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0035173 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C4505437 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0019993 (UMLS CUI [5,3])
C0678274 (UMLS CUI [6,1])
C0558080 (UMLS CUI [6,2])
Gender Contraceptive methods Unwilling | Sexual Abstinence | Condoms, Male | Spermatocidal Agents | Oral Contraceptives Partner Female | Sterilization | Intrauterine Devices
Item
12. male patients not willing to use adequate contraception (sexual abstinence, condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0036899 (UMLS CUI [2])
C0009653 (UMLS CUI [3])
C0037862 (UMLS CUI [4])
C0009905 (UMLS CUI [5,1])
C0682323 (UMLS CUI [5,2])
C0086287 (UMLS CUI [5,3])
C0038288 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
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