ID

29194

Beschreibung

A Study of LY2189265 in Japanese Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01001104

Link

https://clinicaltrials.gov/show/NCT01001104

Stichworte

Versionen (1)
  1. 06.03.18 06.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. März 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01001104

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT01001104

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
japanese patients with type 2 diabetes with a body mass index of 18.5kg/m2 to 40.0kg/m2.
Beschreibung

Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2]
C0011860
UMLS CUI [3]
C1305855
patients who are oral antidiabetic drug(oad) naïve or are taking oad monotherapy except for a dipeptidyl peptidase-4 inhibitor(dpp-iv) and are willing to discontinue their oad.
Beschreibung

Antidiabetics Oral naive | Antidiabetics Oral To be stopped | Exception Dipeptidyl Peptidase 4 Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0919936
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1272691
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2917254
patients who are oad naïve with screening hba1c value of 7.0% to 9.5% and randomization hba1c value of 7.0% to 9.5%, or who are taking oad monotherapy with screening hba1c value of 6.0% to 8.5% and randomization hba1c value of 7.0% to 9.5%.
Beschreibung

Antidiabetics Oral naive | Screening Glucohemoglobin measurement | Randomization Glucohemoglobin measurement | Antidiabetics Oral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0919936
UMLS CUI [2,1]
C0220908
UMLS CUI [2,2]
C0202054
UMLS CUI [3,1]
C0034656
UMLS CUI [3,2]
C0202054
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.
Beschreibung

Stable body weight Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are currently taking ethical medications to promote weight loss
Beschreibung

Weight-Loss Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0376606
patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening.
Beschreibung

Systemic Glucocorticoids chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C0205191
patients who have a known clinically significant gastrointestinal disorder, have undergone excision of gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility.
Beschreibung

Gastrointestinal Diseases | Gastrointestinal tract excision | Gastric Bypass Obesity | Pharmaceutical Preparations chronic Influence Gastrointestinal Motility

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C1293479
UMLS CUI [3,1]
C0017125
UMLS CUI [3,2]
C0028754
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C4054723
UMLS CUI [4,4]
C0017184
patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.
Beschreibung

Poor hypertension control | Renal Artery Stenosis | Labile blood pressure | Postural Hypotension Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2]
C0035067
UMLS CUI [3]
C0428895
UMLS CUI [4,1]
C0020651
UMLS CUI [4,2]
C0231220
patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range.
Beschreibung

Sign or Symptom Pancreatitis | Pancreatitis, Chronic | Pancreatitis | Amylase increased | Lipase increased

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0030305
UMLS CUI [2]
C0149521
UMLS CUI [3]
C0030305
UMLS CUI [4]
C0151479
UMLS CUI [5]
C0549475
have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.
Beschreibung

Familial medullary thyroid carcinoma | Signs Medullary carcinoma of thyroid | Symptoms Medullary carcinoma of thyroid

Datentyp

boolean

Alias
UMLS CUI [1]
C1833921
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0238462
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0238462
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT01001104

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Body mass index
Item
japanese patients with type 2 diabetes with a body mass index of 18.5kg/m2 to 40.0kg/m2.
boolean
C1556094 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
Antidiabetics Oral naive | Antidiabetics Oral To be stopped | Exception Dipeptidyl Peptidase 4 Inhibitors
Item
patients who are oral antidiabetic drug(oad) naïve or are taking oad monotherapy except for a dipeptidyl peptidase-4 inhibitor(dpp-iv) and are willing to discontinue their oad.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,3])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1272691 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C2917254 (UMLS CUI [3,2])
Antidiabetics Oral naive | Screening Glucohemoglobin measurement | Randomization Glucohemoglobin measurement | Antidiabetics Oral
Item
patients who are oad naïve with screening hba1c value of 7.0% to 9.5% and randomization hba1c value of 7.0% to 9.5%, or who are taking oad monotherapy with screening hba1c value of 6.0% to 8.5% and randomization hba1c value of 7.0% to 9.5%.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2,1])
C0202054 (UMLS CUI [2,2])
C0034656 (UMLS CUI [3,1])
C0202054 (UMLS CUI [3,2])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
Stable body weight Duration
Item
patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Weight-Loss Agents
Item
patients who are currently taking ethical medications to promote weight loss
boolean
C0376606 (UMLS CUI [1])
Systemic Glucocorticoids chronic
Item
patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening.
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Gastrointestinal Diseases | Gastrointestinal tract excision | Gastric Bypass Obesity | Pharmaceutical Preparations chronic Influence Gastrointestinal Motility
Item
patients who have a known clinically significant gastrointestinal disorder, have undergone excision of gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility.
boolean
C0017178 (UMLS CUI [1])
C1293479 (UMLS CUI [2])
C0017125 (UMLS CUI [3,1])
C0028754 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C4054723 (UMLS CUI [4,3])
C0017184 (UMLS CUI [4,4])
Poor hypertension control | Renal Artery Stenosis | Labile blood pressure | Postural Hypotension Symptomatic
Item
patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.
boolean
C0421190 (UMLS CUI [1])
C0035067 (UMLS CUI [2])
C0428895 (UMLS CUI [3])
C0020651 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
Sign or Symptom Pancreatitis | Pancreatitis, Chronic | Pancreatitis | Amylase increased | Lipase increased
Item
patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range.
boolean
C3540840 (UMLS CUI [1,1])
C0030305 (UMLS CUI [1,2])
C0149521 (UMLS CUI [2])
C0030305 (UMLS CUI [3])
C0151479 (UMLS CUI [4])
C0549475 (UMLS CUI [5])
Familial medullary thyroid carcinoma | Signs Medullary carcinoma of thyroid | Symptoms Medullary carcinoma of thyroid
Item
have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.
boolean
C1833921 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C0238462 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0238462 (UMLS CUI [3,2])
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