ID

35799

Description

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02254291

Link

https://clinicaltrials.gov/show/NCT02254291

Keywords

Versions (1)
  1. 3/24/19 3/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02254291

English

Eligibility Diabetes NCT02254291

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02254291
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age 20 years or older at the time of signing informed consent
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
glycated hemoglobin (hba1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug (oad) monotherapy and between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy at screening
Description

Hemoglobin A1c measurement | Antidiabetics Oral | Diet therapy | Exercise

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0015259
japanese subjects diagnosed with type 2 diabetes who are: a) on stable oad monotherapy at a half-maximum dose or below according to the approved japanese labelling in addition to diet and exercise therapy for at least 30 days prior to screening (week -8) (for metformin only: the maximum dose of 750 mg/day is allowed except for metgluco®. for metgluco®, the allowable half-max dose of 1125 mg/day must be applied.). 'stable' is defined as unchanged medication and unchanged dose, or b) on stable diet and exercise therapy for at least 30 days prior to screening (week -2)
Description

Study Subject Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral Stable | In addition to Diet therapy | In addition to Exercise | Metformin Dose Maximum U/day | Exception Metformin hydrochloride | Diet therapy Stable | Exercise Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1556094
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0332287
UMLS CUI [4,2]
C0012159
UMLS CUI [5,1]
C0332287
UMLS CUI [5,2]
C0015259
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0806909
UMLS CUI [6,4]
C0456683
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0770893
UMLS CUI [8,1]
C0012159
UMLS CUI [8,2]
C0205360
UMLS CUI [9,1]
C0015259
UMLS CUI [9,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g. abstinence, diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5-week follow-up period
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Vaginal contraceptive diaphragm | Male Condom Partner | Intrauterine Devices | Contraceptive Sponge | Vaginal Spermicides | Contraceptives, Oral

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0042241
UMLS CUI [7,1]
C0009653
UMLS CUI [7,2]
C0682323
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0183461
UMLS CUI [10]
C0087145
UMLS CUI [11]
C0009905
treatment with once-weekly glucagon-like peptide-1 (glp-1) receptor agonists within 90 days prior to screening
Description

GLP-1 Receptor Agonist times/week

Data type

boolean

Alias
UMLS CUI [1,1]
C2917359
UMLS CUI [1,2]
C0456698
treatment with any glucose lowering agent(s) (except for pre-trial oad for subject treated with oad monotherapy) in a period of 60 days prior to screening. an exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness
Description

Hypoglycemic Agents | Exception Antidiabetics Oral | Exception Insulin regime short-term Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0935929
UMLS CUI [2,3]
C1527415
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0557978
UMLS CUI [3,3]
C0443303
UMLS CUI [3,4]
C0009488
any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Description

Disease compromises Patient safety | Disease compromises Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
history of chronic or idiopathic acute pancreatitis
Description

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
screening calcitonin value of 50 ng/l (pg/ml) or greater
Description

Calcitonin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201924
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men2)
Description

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type

Data type

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
impaired renal function defined as estimated glomerular filtration rate (egfr) less than 60 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
Description

Renal Insufficiency | Renal function GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
acute coronary or cerebrovascular event within 90 days before randomisation
Description

Acute Coronary Syndrome | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
heart failure, new york heart association (nyha) class iv
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
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Similar models

Eligibility Diabetes NCT02254291

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02254291
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female, age 20 years or older at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Hemoglobin A1c measurement | Antidiabetics Oral | Diet therapy | Exercise
Item
glycated hemoglobin (hba1c) between 6.5% and 9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug (oad) monotherapy and between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy at screening
boolean
C0474680 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
Study Subject Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral Stable | In addition to Diet therapy | In addition to Exercise | Metformin Dose Maximum U/day | Exception Metformin hydrochloride | Diet therapy Stable | Exercise Stable
Item
japanese subjects diagnosed with type 2 diabetes who are: a) on stable oad monotherapy at a half-maximum dose or below according to the approved japanese labelling in addition to diet and exercise therapy for at least 30 days prior to screening (week -8) (for metformin only: the maximum dose of 750 mg/day is allowed except for metgluco®. for metgluco®, the allowable half-max dose of 1125 mg/day must be applied.). 'stable' is defined as unchanged medication and unchanged dose, or b) on stable diet and exercise therapy for at least 30 days prior to screening (week -2)
boolean
C0681850 (UMLS CUI [1,1])
C1556094 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0332287 (UMLS CUI [4,1])
C0012159 (UMLS CUI [4,2])
C0332287 (UMLS CUI [5,1])
C0015259 (UMLS CUI [5,2])
C0025598 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0806909 (UMLS CUI [6,3])
C0456683 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0770893 (UMLS CUI [7,2])
C0012159 (UMLS CUI [8,1])
C0205360 (UMLS CUI [8,2])
C0015259 (UMLS CUI [9,1])
C0205360 (UMLS CUI [9,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Vaginal contraceptive diaphragm | Male Condom Partner | Intrauterine Devices | Contraceptive Sponge | Vaginal Spermicides | Contraceptives, Oral
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g. abstinence, diaphragm, condom [by the partner], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5-week follow-up period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0009653 (UMLS CUI [7,1])
C0682323 (UMLS CUI [7,2])
C0021900 (UMLS CUI [8])
C0183461 (UMLS CUI [9])
C0087145 (UMLS CUI [10])
C0009905 (UMLS CUI [11])
GLP-1 Receptor Agonist times/week
Item
treatment with once-weekly glucagon-like peptide-1 (glp-1) receptor agonists within 90 days prior to screening
boolean
C2917359 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
Hypoglycemic Agents | Exception Antidiabetics Oral | Exception Insulin regime short-term Comorbidity
Item
treatment with any glucose lowering agent(s) (except for pre-trial oad for subject treated with oad monotherapy) in a period of 60 days prior to screening. an exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0557978 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0009488 (UMLS CUI [3,4])
Disease compromises Patient safety | Disease compromises Protocol Compliance
Item
any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
boolean
C0012634 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value of 50 ng/l (pg/ml) or greater
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function defined as estimated glomerular filtration rate (egfr) less than 60 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Acute Coronary Syndrome | Cerebrovascular accident
Item
acute coronary or cerebrovascular event within 90 days before randomisation
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
heart failure, new york heart association (nyha) class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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