ID

29198

Beschreibung

A Study of LY2599506 in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01024244

Link

https://clinicaltrials.gov/show/NCT01024244

Stichworte

Versionen (1)
  1. 06.03.18 06.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. März 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01024244

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT01024244

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes mellitus prior to entering the trial.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
are currently being treated with diet and exercise therapy consistent with the local standards of medical care.
Beschreibung

Diet therapy | Exercise

Datentyp

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
may be treated with diet and exercise alone or in combination with a stable of metformin for at least 3 month before entering the trial.
Beschreibung

Diet therapy | Exercise | Metformin Dosage Stable | Combined Modality Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4]
C0009429
have a hemoglobin a1c value between 7.0% and 10.0 %, inclusive.
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. male patients will be advised to use a reliable method of birth control during the study and until 3 months after the last dose of study medication if their partner is of child-bearing potential.
Beschreibung

Gender Childbearing Potential Absent | Female Sterilization | Hysterectomy | Bilateral oophorectomy | Tubal Ligation | Menopause | Gender Contraceptive methods | Partner Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0278321
UMLS CUI [5]
C0520483
UMLS CUI [6]
C0025320
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0700589
UMLS CUI [8,1]
C0682323
UMLS CUI [8,2]
C3831118
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of insulin or any antidiabetic agent other than metformin during the 3 months prior entering the trial.
Beschreibung

Insulin | Antidiabetics Except Metformin

Datentyp

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0025598
have a gastrointestinal disease that significantly impacts gastric emptying or motility (for example, severe gastroparesis or pyloric stenosis), in the opinion of the investigator, or have undergone gastric bypass or gastric banding surgery.
Beschreibung

Gastrointestinal Diseases Impact Gastric Emptying | Gastrointestinal Diseases Impact Gastric motility | Gastroparesis Severe | Pyloric Stenosis | Gastric Bypass | Gastric band Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0017127
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0232572
UMLS CUI [3,1]
C0152020
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0034194
UMLS CUI [5]
C0017125
UMLS CUI [6,1]
C3854330
UMLS CUI [6,2]
C0543467
have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness.
Beschreibung

Hypoglycemia Severe Episode Quantity | Loss of hypoglycemic warning

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0342317
have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
Beschreibung

Emergency department patient visit Quantity Due to Poor glycemic control | Hospitalization Quantity Due to Poor glycemic control

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586082
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0342299
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0342299
have cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing.
Beschreibung

Signs Cardiac autonomic neuropathy | Symptoms Cardiac autonomic neuropathy | Cardiac autonomic neuropathy Diagnostic tests | TACHYCARDIA REST | Hypotension, Orthostatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C1740787
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1740787
UMLS CUI [3,1]
C1740787
UMLS CUI [3,2]
C0086143
UMLS CUI [4]
C0749248
UMLS CUI [5]
C0020651
have cardiac disease with functional status that is new york heart association class ii, iii or iv or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 month.
Beschreibung

Heart Disease New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | CONGESTIVE HEART FAILURE DECOMPENSATED

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0742746
have poorly controlled hypertension (that is, mean systolic blood pressure of greater or equal than 160 mm hg or mean diastolic blood pressure of greater or equal than 100 mm hg) history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. doses of antihypertensive medications must be stable for 30 days before randomization.
Beschreibung

Poor hypertension control | Systolic Pressure mean | Diastolic blood pressure mean | Malignant Hypertension | Renal Artery Stenosis | Labile blood pressure | Postural Hypotension Symptomatic | Antihypertensive Agents Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0444504
UMLS CUI [4]
C0020540
UMLS CUI [5]
C0035067
UMLS CUI [6]
C0428895
UMLS CUI [7,1]
C0020651
UMLS CUI [7,2]
C0231220
UMLS CUI [8,1]
C0003364
UMLS CUI [8,2]
C0178602
UMLS CUI [8,3]
C0205360
have fed or fasting state hypertriglyceridemia (defined as >6.8 millimoles per liter [mmol/l], 600 milligrams per deciliter [mg/dl]) at screening. if taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
Beschreibung

Hypertriglyceridemia result | Hypertriglyceridemia result Fasting | Hypoglycemic Agents Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C1522137
UMLS CUI [2,1]
C1522137
UMLS CUI [2,2]
C0015663
UMLS CUI [3,1]
C0020616
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or repeated alanine transaminase (alt) levels >2.5 times the upper limit of the reference range at screening.
Beschreibung

Sign or Symptom Liver disease | Hepatitis | Hepatitis, Chronic | Alanine aminotransferase increased Repeated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0019189
UMLS CUI [4,1]
C0151905
UMLS CUI [4,2]
C0205341
have evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator at screening.
Beschreibung

Abnormality of the endocrine system Uncontrolled | Autoimmune Diseases Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4025823
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0205318
have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Beschreibung

Malignant Neoplasms | Malignant Neoplasms untreated | Cancer in remission | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0687702
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0154088
have a history of seizure disorder.
Beschreibung

Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT01024244

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes mellitus prior to entering the trial.
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Exercise
Item
are currently being treated with diet and exercise therapy consistent with the local standards of medical care.
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
Diet therapy | Exercise | Metformin Dosage Stable | Combined Modality Therapy
Item
may be treated with diet and exercise alone or in combination with a stable of metformin for at least 3 month before entering the trial.
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0009429 (UMLS CUI [4])
Glucohemoglobin measurement
Item
have a hemoglobin a1c value between 7.0% and 10.0 %, inclusive.
boolean
C0202054 (UMLS CUI [1])
Gender Childbearing Potential Absent | Female Sterilization | Hysterectomy | Bilateral oophorectomy | Tubal Ligation | Menopause | Gender Contraceptive methods | Partner Childbearing Potential
Item
are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. male patients will be advised to use a reliable method of birth control during the study and until 3 months after the last dose of study medication if their partner is of child-bearing potential.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0015787 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
C0520483 (UMLS CUI [5])
C0025320 (UMLS CUI [6])
C0079399 (UMLS CUI [7,1])
C0700589 (UMLS CUI [7,2])
C0682323 (UMLS CUI [8,1])
C3831118 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
Insulin | Antidiabetics Except Metformin
Item
use of insulin or any antidiabetic agent other than metformin during the 3 months prior entering the trial.
boolean
C0021641 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0025598 (UMLS CUI [2,3])
Gastrointestinal Diseases Impact Gastric Emptying | Gastrointestinal Diseases Impact Gastric motility | Gastroparesis Severe | Pyloric Stenosis | Gastric Bypass | Gastric band Operative Surgical Procedures
Item
have a gastrointestinal disease that significantly impacts gastric emptying or motility (for example, severe gastroparesis or pyloric stenosis), in the opinion of the investigator, or have undergone gastric bypass or gastric banding surgery.
boolean
C0017178 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0017127 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0232572 (UMLS CUI [2,3])
C0152020 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0034194 (UMLS CUI [4])
C0017125 (UMLS CUI [5])
C3854330 (UMLS CUI [6,1])
C0543467 (UMLS CUI [6,2])
Hypoglycemia Severe Episode Quantity | Loss of hypoglycemic warning
Item
have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0342317 (UMLS CUI [2])
Emergency department patient visit Quantity Due to Poor glycemic control | Hospitalization Quantity Due to Poor glycemic control
Item
have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
boolean
C0586082 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0342299 (UMLS CUI [1,4])
C0019993 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0342299 (UMLS CUI [2,4])
Signs Cardiac autonomic neuropathy | Symptoms Cardiac autonomic neuropathy | Cardiac autonomic neuropathy Diagnostic tests | TACHYCARDIA REST | Hypotension, Orthostatic
Item
have cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing.
boolean
C0311392 (UMLS CUI [1,1])
C1740787 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C1740787 (UMLS CUI [2,2])
C1740787 (UMLS CUI [3,1])
C0086143 (UMLS CUI [3,2])
C0749248 (UMLS CUI [4])
C0020651 (UMLS CUI [5])
Heart Disease New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | CONGESTIVE HEART FAILURE DECOMPENSATED
Item
have cardiac disease with functional status that is new york heart association class ii, iii or iv or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 month.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0742746 (UMLS CUI [4])
Poor hypertension control | Systolic Pressure mean | Diastolic blood pressure mean | Malignant Hypertension | Renal Artery Stenosis | Labile blood pressure | Postural Hypotension Symptomatic | Antihypertensive Agents Dose Stable
Item
have poorly controlled hypertension (that is, mean systolic blood pressure of greater or equal than 160 mm hg or mean diastolic blood pressure of greater or equal than 100 mm hg) history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. doses of antihypertensive medications must be stable for 30 days before randomization.
boolean
C0421190 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0020540 (UMLS CUI [4])
C0035067 (UMLS CUI [5])
C0428895 (UMLS CUI [6])
C0020651 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0003364 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0205360 (UMLS CUI [8,3])
Hypertriglyceridemia result | Hypertriglyceridemia result Fasting | Hypoglycemic Agents Dose Stable
Item
have fed or fasting state hypertriglyceridemia (defined as >6.8 millimoles per liter [mmol/l], 600 milligrams per deciliter [mg/dl]) at screening. if taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
boolean
C1522137 (UMLS CUI [1])
C1522137 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
C0020616 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Sign or Symptom Liver disease | Hepatitis | Hepatitis, Chronic | Alanine aminotransferase increased Repeated
Item
have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or repeated alanine transaminase (alt) levels >2.5 times the upper limit of the reference range at screening.
boolean
C3540840 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0019158 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0151905 (UMLS CUI [4,1])
C0205341 (UMLS CUI [4,2])
Abnormality of the endocrine system Uncontrolled | Autoimmune Diseases Uncontrolled
Item
have evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator at screening.
boolean
C4025823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Malignant Neoplasms | Malignant Neoplasms untreated | Cancer in remission | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of prostate
Item
have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0687702 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0154088 (UMLS CUI [7,2])
Epilepsy
Item
have a history of seizure disorder.
boolean
C0014544 (UMLS CUI [1])
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