ID

32726

Description

A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2); ODM derived from: https://clinicaltrials.gov/show/NCT00637273

Lien

https://clinicaltrials.gov/show/NCT00637273

Mots-clés

Versions (1)
  1. 13/11/2018 13/11/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

13 novembre 2018

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 Type 2 Diabetes Mellitus NCT00637273

Anglais

Eligibility Type 2 Diabetes Mellitus NCT00637273

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has been diagnosed with type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
has a hemoglobin-specific a1c fraction (hba1c) of 7.1% to 11.0%, inclusive, at study start
Description

Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0474680
has a body mass index (bmi)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
Description

Metformin Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0205360
either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
Description

Pharmacotherapy Absent | Pharmacotherapy Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0205360
1. hormone replacement therapy (female subjects)
Description

Hormone replacement therapy | Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C0079399
2. oral contraceptives (female subjects)
Description

Contraceptives, Oral | Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0009905
UMLS CUI [2]
C0079399
3. antihypertensive agents
Description

Antihypertensive Agents

Type de données

boolean

Alias
UMLS CUI [1]
C0003364
4. lipid-lowering agents
Description

Hypolipidemic Agents

Type de données

boolean

Alias
UMLS CUI [1]
C0086440
5. thyroid replacement therapy
Description

Thyroid hormone replacement therapy

Type de données

boolean

Alias
UMLS CUI [1]
C2242640
6. antidepressant agents
Description

Antidepressive Agents

Type de données

boolean

Alias
UMLS CUI [1]
C0003289
7. drugs known to affect body weight, including prescription medications (e.g. orlistat [xenical®], sibutramine [meridia®], topiramate [topamax®]) and over-the-counter antiobesity agents
Description

Pharmaceutical Preparations Affecting Body Weight | orlistat | Xenical | sibutramine | Meridia | topiramate | Topamax | Anti-Obesity Agents over-the-counter

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005910
UMLS CUI [2]
C0076275
UMLS CUI [3]
C0732649
UMLS CUI [4]
C0074493
UMLS CUI [5]
C0635898
UMLS CUI [6]
C0076829
UMLS CUI [7]
C0723778
UMLS CUI [8,1]
C0376607
UMLS CUI [8,2]
C0013231
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has been previously exposed to exenatide once weekly
Description

Exposure to Exenatide

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0167117
has donated blood within 60 days of study start or is planning to donate blood during the study
Description

Blood Donation | Blood Donation Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1301732
currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
Description

Pharmaceutical Preparations Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
1. exenatide (byetta®) or any dipeptidyl peptidase-4 dpp-4)inhibitor, sulfonylurea (su), thiazolidinedione (tzd), or glucagon-like peptide (glp)-1 analog within 3 months prior to study start
Description

Exenatide | Byetta | Dipeptidyl-Peptidase IV Inhibitors | Sulfonylureas | Thiazolidinediones | Glucagon-like peptide-1 (GLP-1) analogues

Type de données

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C1636686
UMLS CUI [3]
C1827106
UMLS CUI [4]
C0038766
UMLS CUI [5]
C1257987
UMLS CUI [6]
C4301632
2. alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®) within 30 days of study start
Description

alpha-Glucosidase Inhibitors | Meglitinide | nateglinide | Pramlintide | Symlin

Type de données

boolean

Alias
UMLS CUI [1]
C1299007
UMLS CUI [2]
C0065880
UMLS CUI [3]
C0903898
UMLS CUI [4]
C0537551
UMLS CUI [5]
C1174780
3. insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
Description

Insulin

Type de données

boolean

Alias
UMLS CUI [1]
C0021641
4. systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption
Description

CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Intravenous | CORTICOSTEROIDS FOR SYSTEMIC USE Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Advair

Type de données

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C3653708
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C3653708
UMLS CUI [3,2]
C1556154
UMLS CUI [4]
C2065041
UMLS CUI [5,1]
C0038317
UMLS CUI [5,2]
C1522224
UMLS CUI [6]
C0965130
5. drugs interacting with the cyp2c8 enzyme system, including gemfibrozil (lopid®) and rifampin
Description

Pharmaceutical Preparations Interaction CYP2C8 | Gemfibrozil | Lopid | Rifampin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C1382144
UMLS CUI [2]
C0017245
UMLS CUI [3]
C0700003
UMLS CUI [4]
C0035608
has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
has previously experienced a clinically significant adverse event (e.g., significant edema) related to tzd or dpp-4 inhibitor use
Description

Adverse event Thiazolidinediones Related | Adverse event DPP-IV Inhibitors Related | Edema

Type de données

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1257987
UMLS CUI [1,3]
C0439849
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C1827106
UMLS CUI [2,3]
C0439849
UMLS CUI [3]
C0013604
Retour au début de la page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00637273

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
has been diagnosed with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
has a hemoglobin-specific a1c fraction (hba1c) of 7.1% to 11.0%, inclusive, at study start
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
has a body mass index (bmi)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
boolean
C1305855 (UMLS CUI [1])
Metformin Stable
Item
has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Pharmacotherapy Absent | Pharmacotherapy Stable
Item
either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
boolean
C0013216 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0013216 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Hormone replacement therapy | Gender
Item
1. hormone replacement therapy (female subjects)
boolean
C0282402 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Contraceptives, Oral | Gender
Item
2. oral contraceptives (female subjects)
boolean
C0009905 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Antihypertensive Agents
Item
3. antihypertensive agents
boolean
C0003364 (UMLS CUI [1])
Hypolipidemic Agents
Item
4. lipid-lowering agents
boolean
C0086440 (UMLS CUI [1])
Thyroid hormone replacement therapy
Item
5. thyroid replacement therapy
boolean
C2242640 (UMLS CUI [1])
Antidepressive Agents
Item
6. antidepressant agents
boolean
C0003289 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Body Weight | orlistat | Xenical | sibutramine | Meridia | topiramate | Topamax | Anti-Obesity Agents over-the-counter
Item
7. drugs known to affect body weight, including prescription medications (e.g. orlistat [xenical®], sibutramine [meridia®], topiramate [topamax®]) and over-the-counter antiobesity agents
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0076275 (UMLS CUI [2])
C0732649 (UMLS CUI [3])
C0074493 (UMLS CUI [4])
C0635898 (UMLS CUI [5])
C0076829 (UMLS CUI [6])
C0723778 (UMLS CUI [7])
C0376607 (UMLS CUI [8,1])
C0013231 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
Exposure to Exenatide
Item
has been previously exposed to exenatide once weekly
boolean
C0332157 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
Blood Donation | Blood Donation Planned
Item
has donated blood within 60 days of study start or is planning to donate blood during the study
boolean
C0005794 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Pharmaceutical Preparations Excluded
Item
currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Exenatide | Byetta | Dipeptidyl-Peptidase IV Inhibitors | Sulfonylureas | Thiazolidinediones | Glucagon-like peptide-1 (GLP-1) analogues
Item
1. exenatide (byetta®) or any dipeptidyl peptidase-4 dpp-4)inhibitor, sulfonylurea (su), thiazolidinedione (tzd), or glucagon-like peptide (glp)-1 analog within 3 months prior to study start
boolean
C0167117 (UMLS CUI [1])
C1636686 (UMLS CUI [2])
C1827106 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
C4301632 (UMLS CUI [6])
alpha-Glucosidase Inhibitors | Meglitinide | nateglinide | Pramlintide | Symlin
Item
2. alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®) within 30 days of study start
boolean
C1299007 (UMLS CUI [1])
C0065880 (UMLS CUI [2])
C0903898 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
C1174780 (UMLS CUI [5])
Insulin
Item
3. insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
boolean
C0021641 (UMLS CUI [1])
CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Intravenous | CORTICOSTEROIDS FOR SYSTEMIC USE Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Advair
Item
4. systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption
boolean
C3653708 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C3653708 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4])
C0038317 (UMLS CUI [5,1])
C1522224 (UMLS CUI [5,2])
C0965130 (UMLS CUI [6])
Pharmaceutical Preparations Interaction CYP2C8 | Gemfibrozil | Lopid | Rifampin
Item
5. drugs interacting with the cyp2c8 enzyme system, including gemfibrozil (lopid®) and rifampin
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C1382144 (UMLS CUI [1,3])
C0017245 (UMLS CUI [2])
C0700003 (UMLS CUI [3])
C0035608 (UMLS CUI [4])
Investigational New Drugs
Item
has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
boolean
C0013230 (UMLS CUI [1])
Adverse event Thiazolidinediones Related | Adverse event DPP-IV Inhibitors Related | Edema
Item
has previously experienced a clinically significant adverse event (e.g., significant edema) related to tzd or dpp-4 inhibitor use
boolean
C0877248 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0877248 (UMLS CUI [2,1])
C1827106 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013604 (UMLS CUI [3])
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