ID

35802

Description

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02305381

Link

https://clinicaltrials.gov/show/NCT02305381

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 NCT02305381

English

Eligibility Diabetes NCT02305381

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02305381
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age at least 18 years at the time of signing inform consent. for japan: male or female, age at least 20 years at the time of signing informed consent
Description

Age | Informed Consent | Japan

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0022341
subjects diagnosed with t2dm (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 iu/kg/day and/or 20 iu/day of: insulin glargine, insulin detemir, insulin degludec and/or nph insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening
Description

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Stable | Basal insulin Dosage | Insulin Glargine | Insulin detemir | Insulin degludec | Insulin, isophane | Combined Modality Therapy | Metformin U/day | Metformin Maximum Tolerated Dose

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0650607
UMLS CUI [3,2]
C0178602
UMLS CUI [4]
C0907402
UMLS CUI [5]
C0537270
UMLS CUI [6]
C3491971
UMLS CUI [7]
C0021658
UMLS CUI [8]
C0009429
UMLS CUI [9,1]
C0025598
UMLS CUI [9,2]
C0456683
UMLS CUI [10,1]
C0025598
UMLS CUI [10,2]
C0752079
hba1c (glycosylated haemoglobin) 7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
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 throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). germany: only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. japan: adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Contraceptive injection | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy | Vaginal contraceptive diaphragm | Male Condom Partner | 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]
C1657106
UMLS CUI [6]
C1656586
UMLS CUI [7]
C0009906
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0036899
UMLS CUI [10]
C0420842
UMLS CUI [11]
C0042241
UMLS CUI [12,1]
C0009653
UMLS CUI [12,2]
C0682323
UMLS CUI [13]
C0183461
UMLS CUI [14]
C0087145
UMLS CUI [15]
C0009905
treatment with any glucose lowering agents other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (7 days or less in total) with bolus insulin in connection with intercurrent illness
Description

Hypoglycemic Agents | Exception Inclusion criteria | Exception Bolus Insulin short-term | Exception Bolus Insulin Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1705509
UMLS CUI [3,3]
C0021641
UMLS CUI [3,4]
C0443303
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1705509
UMLS CUI [4,3]
C0021641
UMLS CUI [4,4]
C0009488
experienced more than 3 episodes of severe hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness
Description

Episode Quantity Hypoglycemia Severe | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020615
UMLS CUI [1,4]
C0205082
UMLS CUI [2]
C0342317
history of pancreatitis (acute or chronic)
Description

Pancreatitis | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
screening calcitonin value above or equal to 50 ng/l (pg/ml)
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 2 (men 2)
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
severe renal impairment defined as egfr (estimated glomerular filtration rate) below 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
Description

Renal Insufficiency Severe | Renal function GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
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 NCT02305381

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02305381
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent | Japan
Item
male or female, age at least 18 years at the time of signing inform consent. for japan: male or female, age at least 20 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0022341 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Stable | Basal insulin Dosage | Insulin Glargine | Insulin detemir | Insulin degludec | Insulin, isophane | Combined Modality Therapy | Metformin U/day | Metformin Maximum Tolerated Dose
Item
subjects diagnosed with t2dm (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 iu/kg/day and/or 20 iu/day of: insulin glargine, insulin detemir, insulin degludec and/or nph insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0650607 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0907402 (UMLS CUI [4])
C0537270 (UMLS CUI [5])
C3491971 (UMLS CUI [6])
C0021658 (UMLS CUI [7])
C0009429 (UMLS CUI [8])
C0025598 (UMLS CUI [9,1])
C0456683 (UMLS CUI [9,2])
C0025598 (UMLS CUI [10,1])
C0752079 (UMLS CUI [10,2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Contraceptive injection | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy | Vaginal contraceptive diaphragm | Male Condom Partner | 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 throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). germany: only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. japan: adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives
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])
C1657106 (UMLS CUI [5])
C1656586 (UMLS CUI [6])
C0009906 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
C0042241 (UMLS CUI [11])
C0009653 (UMLS CUI [12,1])
C0682323 (UMLS CUI [12,2])
C0183461 (UMLS CUI [13])
C0087145 (UMLS CUI [14])
C0009905 (UMLS CUI [15])
Hypoglycemic Agents | Exception Inclusion criteria | Exception Bolus Insulin short-term | Exception Bolus Insulin Comorbidity
Item
treatment with any glucose lowering agents other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (7 days or less in total) with bolus insulin in connection with intercurrent illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1705509 (UMLS CUI [3,2])
C0021641 (UMLS CUI [3,3])
C0443303 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1705509 (UMLS CUI [4,2])
C0021641 (UMLS CUI [4,3])
C0009488 (UMLS CUI [4,4])
Episode Quantity Hypoglycemia Severe | Loss of hypoglycemic warning
Item
experienced more than 3 episodes of severe hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0342317 (UMLS CUI [2])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value above or equal to 50 ng/l (pg/ml)
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 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Renal Insufficiency Severe | Renal function GFR estimation by MDRD
Item
severe renal impairment defined as egfr (estimated glomerular filtration rate) below 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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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