ID

32726

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00637273

Palabras clave

Versiones (1)
  1. 13/11/18 13/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

13 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00637273

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00637273

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

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

Hemoglobin A1c measurement

Tipo de datos

boolean

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

Body mass index

Tipo de datos

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
Descripción

Metformin Stable

Tipo de datos

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:
Descripción

Pharmacotherapy Absent | Pharmacotherapy Stable

Tipo de datos

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)
Descripción

Hormone replacement therapy | Gender

Tipo de datos

boolean

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

Contraceptives, Oral | Gender

Tipo de datos

boolean

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

Antihypertensive Agents

Tipo de datos

boolean

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

Hypolipidemic Agents

Tipo de datos

boolean

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

Thyroid hormone replacement therapy

Tipo de datos

boolean

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

Antidepressive Agents

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria

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

Exposure to Exenatide

Tipo de datos

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
Descripción

Blood Donation | Blood Donation Planned

Tipo de datos

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:
Descripción

Pharmaceutical Preparations Excluded

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Insulin

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Pharmaceutical Preparations Interaction CYP2C8 | Gemfibrozil | Lopid | Rifampin

Tipo de datos

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
Descripción

Investigational New Drugs

Tipo de datos

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
Descripción

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

Tipo de datos

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
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00637273

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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