ID

39010

Description

Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01652729

Lien

https://clinicaltrials.gov/show/NCT01652729

Mots-clés

Versions (1)
  1. 19/11/2019 19/11/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

19 novembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Diabetes Type 2 NCT01652729

Anglais

Eligibility Diabetes Type 2 NCT01652729

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 18 years old
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
hba1c of 7.1% to 11.0%, inclusive, at screening
Description

Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0474680
has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
Description

Stable body weight

Type de données

boolean

Alias
UMLS CUI [1]
C0517386
fasting plasma glucose concentration <280 mg/dl (15.5 mmol/l) at screening
Description

Plasma fasting glucose measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
body mass index of <45 kg/m2 at screening
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to visit 1 (screening)
Description

Metformin Dose Stable U/day

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of pancreatitis or triglycerides >=500 mg/dl
Description

Pancreatitis | Triglycerides measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0202236
medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either
Description

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type

Type de données

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
history of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 ml/min
Description

Kidney Transplantation | Dialysis procedure | Estimated creatine clearance

Type de données

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
UMLS CUI [3]
C1273051
active cardiovascular disease
Description

Cardiovascular Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
presence or history of severe congestive heart failure
Description

Congestive heart failure Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205082
central nervous system disease, including epilepsy
Description

CNS disorder | Epilepsy

Type de données

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0014544
liver disease
Description

Liver disease

Type de données

boolean

Alias
UMLS CUI [1]
C0023895
history of severe gastrointestinal diseases
Description

Gastrointestinal Diseases Severe (

Type de données

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205082
clinically significant malignant disease
Description

Malignant disease

Type de données

boolean

Alias
UMLS CUI [1]
C0442867
repeated severe hypoglycemia within the last 6 months
Description

Hypoglycemia Severe Repeated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205341
any exposure to exenatide (byetta® or bydureon™) or any glp-1 analog
Description

Exposure to Exenatide | Exposure to Byetta | Exposure to Bydureon | Exposure to GLP-1 Analogue

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0167117
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C1636686
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C3257792
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C3273809
any dpp-4 inhibitor within 3 months prior screening
Description

Dipeptidyl Peptidase-4 Inhibitor

Type de données

boolean

Alias
UMLS CUI [1]
C3537225
Retour au début de la page

Similar models

Eligibility Diabetes Type 2 NCT01652729

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c of 7.1% to 11.0%, inclusive, at screening
boolean
C0474680 (UMLS CUI [1])
Stable body weight
Item
has stable body weight, i.e., not varying by >3% for at least 3 months prior to screening
boolean
C0517386 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose concentration <280 mg/dl (15.5 mmol/l) at screening
boolean
C0583513 (UMLS CUI [1])
Body mass index
Item
body mass index of <45 kg/m2 at screening
boolean
C1305855 (UMLS CUI [1])
Metformin Dose Stable U/day
Item
has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to visit 1 (screening)
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Pancreatitis | Triglycerides measurement
Item
history of pancreatitis or triglycerides >=500 mg/dl
boolean
C0030305 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Kidney Transplantation | Dialysis procedure | Estimated creatine clearance
Item
history of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance <50 ml/min
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C1273051 (UMLS CUI [3])
Cardiovascular Disease
Item
active cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Congestive heart failure Severe
Item
presence or history of severe congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
CNS disorder | Epilepsy
Item
central nervous system disease, including epilepsy
boolean
C0007682 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
Liver disease
Item
liver disease
boolean
C0023895 (UMLS CUI [1])
Gastrointestinal Diseases Severe (
Item
history of severe gastrointestinal diseases
boolean
C0017178 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Malignant disease
Item
clinically significant malignant disease
boolean
C0442867 (UMLS CUI [1])
Hypoglycemia Severe Repeated
Item
repeated severe hypoglycemia within the last 6 months
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Exposure to Exenatide | Exposure to Byetta | Exposure to Bydureon | Exposure to GLP-1 Analogue
Item
any exposure to exenatide (byetta® or bydureon™) or any glp-1 analog
boolean
C0332157 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1636686 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C3257792 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C3273809 (UMLS CUI [4,2])
Dipeptidyl Peptidase-4 Inhibitor
Item
any dpp-4 inhibitor within 3 months prior screening
boolean
C3537225 (UMLS CUI [1])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial