ID

39030

Descrizione

A Study to Evaluate the Safety and Effectiveness of DM199 in Healthy Subjects and Type 2 Diabetes Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01845064

collegamento

https://clinicaltrials.gov/show/NCT01845064

Keywords

versioni (1)
  1. 22/11/19 22/11/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

22 novembre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Diabetes Type 2 NCT01845064

Inglese

Eligibility Diabetes Type 2 NCT01845064

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. status : parts a and c: healthy subjects
Descrizione

Healthy Volunteers

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1708335
parts b and d: type 2 diabetes mellitus patients :
Descrizione

Patients Non-Insulin-Dependent Diabetes Mellitus

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0011860
2. body mass index : parts a and c: 18.0 - 30.0 kg/m2
Descrizione

Body mass index

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
parts b and d: 25.0 - 35.0 kg/m2
Descrizione

Body mass index

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
3. hba1c : parts b and d: at screening between 6.5% and 9.0%, inclusive for patients using one oral anti-diabetic medication, and between 6.0% and 8.5%, inclusive for patients using two or more oral anti-diabetic medications
Descrizione

Hemoglobin A1c measurement | Antidiabetics Oral Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
4. fasting blood glucose : parts b and d: within 7.5-13.5 mmol/l, inclusive at entry into the clinical research center (day -1 for part b or day -2 for part d)
Descrizione

Fasting blood glucose measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0428568
5. women of childbearing potential agree to use an appropriate contraceptive method (hormonal, iud, or diaphragm) until 90 days after the follow-up visit. for males: willingness to use adequate contraception from entry in the clinical research center until 90 days after the follow-up visit
Descrizione

Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Gender Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C2985296
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0042241
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0700589
6. medical history without clinically significant abnormalities
Descrizione

Abnormality Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0332197
7. parts b and d: taking a stable dose of one or more oral anti-diabetic medications, such as metformin, sulphonylurea or any other orally administered glucose lowering medication (except for thiazolidinediones) for at least 3 months prior to screening. receiving no other chronic medications, including dietary supplements, that alter blood glucose control.
Descrizione

Antidiabetics Oral Quantity | Metformin | Sulfonylurea | Hypoglycemic Agents Oral | Exception Thiazolidinediones | Absence Pharmaceutical Preparations Changing GLUCOSE CONTROL | Pharmaceutical Preparations chronic Absent | Dietary Supplements Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0038766
UMLS CUI [4,1]
C0020616
UMLS CUI [4,2]
C1527415
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1257987
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0013227
UMLS CUI [6,3]
C0392747
UMLS CUI [6,4]
C0726398
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0205191
UMLS CUI [7,3]
C0332197
UMLS CUI [8,1]
C0242295
UMLS CUI [8,2]
C0332197
8. parts a and c: resting supine blood pressure of 140/90 mmhg or lower and higher than 90/50mmhg at screening, and showing no clinically relevant deviations as judged by the principal investigator
Descrizione

Lying systolic blood pressure Resting | Lying diastolic blood pressure Resting

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1319895
UMLS CUI [1,2]
C0035253
UMLS CUI [2,1]
C1319896
UMLS CUI [2,2]
C0035253
9. parts b and d: resting supine blood pressure of 160/100 mmhg or lower and higher than 90/50mmhg at screening, and showing no clinically relevant deviations as judged by the principal investigator
Descrizione

Lying systolic blood pressure Resting | Lying diastolic blood pressure Resting

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1319895
UMLS CUI [1,2]
C0035253
UMLS CUI [2,1]
C1319896
UMLS CUI [2,2]
C0035253
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. evidence of clinically relevant pathology
Descrizione

Pathology Relevance Clinical

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0677042
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
2. pregnancy or lactation
Descrizione

Pregnancy | Breast Feeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. for healthy volunteers: use of concomitant medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entry into the clinical research center (after that time the use of a limited amount of acetaminophen is permitted after consultation with the principal investigator). multivitamins and vitamin c are allowed up to 7 days before entry into the clinical research center. all other medication (including over the counter medication, health supplements, and herbal remedies such as st. john's wort extract) must have been stopped at least 14 days prior to entry into the clinical research center.
Descrizione

Healthy Volunteers | Pharmaceutical Preparations concomitant | Exception Acetaminophen | Multivitamin preparation allowed | Ascorbic Acid allowed | Status pre- Enrollment | Pharmaceutical Preparations Other To be stopped | Non-Prescription Drugs To be stopped | Supplements To be stopped | Medicinal Herbs To be stopped | ST. JOHN'S WORT EXTRACT To be stopped

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521115
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0000970
UMLS CUI [4,1]
C0301532
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0003968
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0332152
UMLS CUI [6,2]
C1516879
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C0205394
UMLS CUI [7,3]
C1272691
UMLS CUI [8,1]
C0013231
UMLS CUI [8,2]
C1272691
UMLS CUI [9,1]
C0242295
UMLS CUI [9,2]
C1272691
UMLS CUI [10,1]
C0025125
UMLS CUI [10,2]
C1272691
UMLS CUI [11,1]
C0813171
UMLS CUI [11,2]
C1272691
4. participation in a drug study within 60 days prior to drug administration. participation in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months preceding the start of this study)
Descrizione

Study Subject Participation Status | Investigational New Drugs | Clinical Trials Quantity | Gender

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0079399
5. positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
Descrizione

Drug screen positive | Opiates | Methadone | Cocaine | Amphetamines | Cannabinoids | Barbiturates | Benzodiazepines | Tricyclic Antidepressive Agents | Alcohol

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0743295
UMLS CUI [2]
C0376196
UMLS CUI [3]
C0025605
UMLS CUI [4]
C0009170
UMLS CUI [5]
C0002667
UMLS CUI [6]
C0006864
UMLS CUI [7]
C0004745
UMLS CUI [8]
C0005064
UMLS CUI [9]
C0003290
UMLS CUI [10]
C0001962
6. intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 ml of beer, 100 ml of wine or 35 ml of spirits)
Descrizione

Alcohol consumption U/week | Beer U/week | Wine U/week | Spirits U/week

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560588
UMLS CUI [2,1]
C0004922
UMLS CUI [2,2]
C0560588
UMLS CUI [3,1]
C0043188
UMLS CUI [3,2]
C0560588
UMLS CUI [4,1]
C0301611
UMLS CUI [4,2]
C0560588
7. positive screen on hbsag, anti-hcv or anti-hiv 1/2
Descrizione

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV-1 antibody Positive | HIV-2 antibody Positive

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3,1]
C0369497
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C0369500
UMLS CUI [4,2]
C1514241
8. illness within 7 days prior to (the first) drug administration
Descrizione

Illness Recent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0332185
9. serum creatinine > upper limit of the normal (uln) range
Descrizione

Serum creatinine raised

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0700225
additional exclusion criteria specific to type 2 diabetes mellitus patients (part b and part d)
Descrizione

Exclusion Criteria Additional | Patients Non-Insulin-Dependent Diabetes Mellitus

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0011860
10. the use of insulin and thiazolidinediones for type 2 diabetes mellitus 3 months prior to screening is not allowed.
Descrizione

Insulin use Non-Insulin-Dependent Diabetes Mellitus | Thiazolidinediones Non-Insulin-Dependent Diabetes Mellitus

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0240016
UMLS CUI [1,2]
C0011860
UMLS CUI [2,1]
C1257987
UMLS CUI [2,2]
C0011860
11. the use of angiotensin converting enzyme (ace) inhibitors 1 month prior to screening is not allowed.
Descrizione

Angiotensin-Converting Enzyme Inhibitors

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003015
12. history of diabetic ketoacidosis or hyperosmolar coma
Descrizione

Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C3888846
13. advanced diabetic complications, including neuropathy, nephropathy, retinopathy or other symptoms
Descrizione

Complications of Diabetes Mellitus Advanced | Neuropathy | Kidney Diseases | Retinal Diseases | Symptoms

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0442874
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0035309
UMLS CUI [5]
C1457887
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Similar models

Eligibility Diabetes Type 2 NCT01845064

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers
Item
1. status : parts a and c: healthy subjects
boolean
C1708335 (UMLS CUI [1])
Patients Non-Insulin-Dependent Diabetes Mellitus
Item
parts b and d: type 2 diabetes mellitus patients :
boolean
C0030705 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Body mass index
Item
2. body mass index : parts a and c: 18.0 - 30.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Body mass index
Item
parts b and d: 25.0 - 35.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement | Antidiabetics Oral Quantity
Item
3. hba1c : parts b and d: at screening between 6.5% and 9.0%, inclusive for patients using one oral anti-diabetic medication, and between 6.0% and 8.5%, inclusive for patients using two or more oral anti-diabetic medications
boolean
C0474680 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Fasting blood glucose measurement
Item
4. fasting blood glucose : parts b and d: within 7.5-13.5 mmol/l, inclusive at entry into the clinical research center (day -1 for part b or day -2 for part d)
boolean
C0428568 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Gender Contraceptive methods
Item
5. women of childbearing potential agree to use an appropriate contraceptive method (hormonal, iud, or diaphragm) until 90 days after the follow-up visit. for males: willingness to use adequate contraception from entry in the clinical research center until 90 days after the follow-up visit
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Abnormality Absent
Item
6. medical history without clinically significant abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Antidiabetics Oral Quantity | Metformin | Sulfonylurea | Hypoglycemic Agents Oral | Exception Thiazolidinediones | Absence Pharmaceutical Preparations Changing GLUCOSE CONTROL | Pharmaceutical Preparations chronic Absent | Dietary Supplements Absent
Item
7. parts b and d: taking a stable dose of one or more oral anti-diabetic medications, such as metformin, sulphonylurea or any other orally administered glucose lowering medication (except for thiazolidinediones) for at least 3 months prior to screening. receiving no other chronic medications, including dietary supplements, that alter blood glucose control.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C0020616 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1257987 (UMLS CUI [5,2])
C0332197 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C0392747 (UMLS CUI [6,3])
C0726398 (UMLS CUI [6,4])
C0013227 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
C0242295 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
Lying systolic blood pressure Resting | Lying diastolic blood pressure Resting
Item
8. parts a and c: resting supine blood pressure of 140/90 mmhg or lower and higher than 90/50mmhg at screening, and showing no clinically relevant deviations as judged by the principal investigator
boolean
C1319895 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C1319896 (UMLS CUI [2,1])
C0035253 (UMLS CUI [2,2])
Lying systolic blood pressure Resting | Lying diastolic blood pressure Resting
Item
9. parts b and d: resting supine blood pressure of 160/100 mmhg or lower and higher than 90/50mmhg at screening, and showing no clinically relevant deviations as judged by the principal investigator
boolean
C1319895 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C1319896 (UMLS CUI [2,1])
C0035253 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pathology Relevance Clinical
Item
1. evidence of clinically relevant pathology
boolean
C0677042 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
2. pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Healthy Volunteers | Pharmaceutical Preparations concomitant | Exception Acetaminophen | Multivitamin preparation allowed | Ascorbic Acid allowed | Status pre- Enrollment | Pharmaceutical Preparations Other To be stopped | Non-Prescription Drugs To be stopped | Supplements To be stopped | Medicinal Herbs To be stopped | ST. JOHN'S WORT EXTRACT To be stopped
Item
3. for healthy volunteers: use of concomitant medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entry into the clinical research center (after that time the use of a limited amount of acetaminophen is permitted after consultation with the principal investigator). multivitamins and vitamin c are allowed up to 7 days before entry into the clinical research center. all other medication (including over the counter medication, health supplements, and herbal remedies such as st. john's wort extract) must have been stopped at least 14 days prior to entry into the clinical research center.
boolean
C1708335 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0521115 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
C0301532 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0003968 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0332152 (UMLS CUI [6,1])
C1516879 (UMLS CUI [6,2])
C0013227 (UMLS CUI [7,1])
C0205394 (UMLS CUI [7,2])
C1272691 (UMLS CUI [7,3])
C0013231 (UMLS CUI [8,1])
C1272691 (UMLS CUI [8,2])
C0242295 (UMLS CUI [9,1])
C1272691 (UMLS CUI [9,2])
C0025125 (UMLS CUI [10,1])
C1272691 (UMLS CUI [10,2])
C0813171 (UMLS CUI [11,1])
C1272691 (UMLS CUI [11,2])
Study Subject Participation Status | Investigational New Drugs | Clinical Trials Quantity | Gender
Item
4. participation in a drug study within 60 days prior to drug administration. participation in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months preceding the start of this study)
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0008976 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4])
Drug screen positive | Opiates | Methadone | Cocaine | Amphetamines | Cannabinoids | Barbiturates | Benzodiazepines | Tricyclic Antidepressive Agents | Alcohol
Item
5. positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
boolean
C0743295 (UMLS CUI [1])
C0376196 (UMLS CUI [2])
C0025605 (UMLS CUI [3])
C0009170 (UMLS CUI [4])
C0002667 (UMLS CUI [5])
C0006864 (UMLS CUI [6])
C0004745 (UMLS CUI [7])
C0005064 (UMLS CUI [8])
C0003290 (UMLS CUI [9])
C0001962 (UMLS CUI [10])
Alcohol consumption U/week | Beer U/week | Wine U/week | Spirits U/week
Item
6. intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 ml of beer, 100 ml of wine or 35 ml of spirits)
boolean
C0001948 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
C0004922 (UMLS CUI [2,1])
C0560588 (UMLS CUI [2,2])
C0043188 (UMLS CUI [3,1])
C0560588 (UMLS CUI [3,2])
C0301611 (UMLS CUI [4,1])
C0560588 (UMLS CUI [4,2])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV-1 antibody Positive | HIV-2 antibody Positive
Item
7. positive screen on hbsag, anti-hcv or anti-hiv 1/2
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0369497 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0369500 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
Illness Recent
Item
8. illness within 7 days prior to (the first) drug administration
boolean
C0221423 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Serum creatinine raised
Item
9. serum creatinine > upper limit of the normal (uln) range
boolean
C0700225 (UMLS CUI [1])
Exclusion Criteria Additional | Patients Non-Insulin-Dependent Diabetes Mellitus
Item
additional exclusion criteria specific to type 2 diabetes mellitus patients (part b and part d)
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Insulin use Non-Insulin-Dependent Diabetes Mellitus | Thiazolidinediones Non-Insulin-Dependent Diabetes Mellitus
Item
10. the use of insulin and thiazolidinediones for type 2 diabetes mellitus 3 months prior to screening is not allowed.
boolean
C0240016 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C1257987 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Angiotensin-Converting Enzyme Inhibitors
Item
11. the use of angiotensin converting enzyme (ace) inhibitors 1 month prior to screening is not allowed.
boolean
C0003015 (UMLS CUI [1])
Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State
Item
12. history of diabetic ketoacidosis or hyperosmolar coma
boolean
C0011880 (UMLS CUI [1])
C3888846 (UMLS CUI [2])
Complications of Diabetes Mellitus Advanced | Neuropathy | Kidney Diseases | Retinal Diseases | Symptoms
Item
13. advanced diabetic complications, including neuropathy, nephropathy, retinopathy or other symptoms
boolean
C0342257 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0442874 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0035309 (UMLS CUI [4])
C1457887 (UMLS CUI [5])
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