ID

38769

Beschreibung

A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01691989

Link

https://clinicaltrials.gov/show/NCT01691989

Stichworte

Versionen (2)
  1. 02.11.19 02.11.19 -
  2. 02.11.19 02.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. November 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Diabetes Mellitus, Type 2 NCT01691989

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT01691989

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/=18 years of age
Beschreibung

Adult | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
diagnosis of diabetes mellitus, type 2
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 12 weeks prior to screening
Beschreibung

Sulfonylurea Stable | Metformin | Combined Modality Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038766
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0009429
hba1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
fasting plasma glucose </=240 mg/dl at pre-randomization visit
Beschreibung

Plasma fasting glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
agreement to maintain diet and exercise habits during the study
Beschreibung

Diet therapy Maintenance | Exercise Habits Maintenance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0024501
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0018464
UMLS CUI [2,3]
C0024501
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus | Diabetes Mellitus Due to Injury of pancreas | Complications of Diabetes Mellitus Metabolic

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0271640
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0273163
UMLS CUI [4,1]
C0342257
UMLS CUI [4,2]
C0311400
any previous treatment with thiazolidinedione or a dual ppar agonist
Beschreibung

Thiazolidinediones | Peroxisome Proliferator-Activated Receptor Agonist Dual

Datentyp

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2,1]
C0166418
UMLS CUI [2,2]
C2987634
UMLS CUI [2,3]
C0205173
any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
Beschreibung

Weight reduction regimen | Lipoprotein modification Therapy | Exception Statins Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0311130
UMLS CUI [2,1]
C1158918
UMLS CUI [2,2]
C0087111
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0360714
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening
Beschreibung

Hypoglycemic Agents | Exception Sulfonylurea | Exception Metformin | Exception Combined Modality Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0038766
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025598
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0009429
symptomatic congestive heart failure classified as new york heart association class ii-iv at screening
Beschreibung

Symptomatic congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C1275491
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT01691989

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/=18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of diabetes mellitus, type 2
boolean
C0011860 (UMLS CUI [1])
Sulfonylurea Stable | Metformin | Combined Modality Therapy
Item
patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 12 weeks prior to screening
boolean
C0038766 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
hba1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose </=240 mg/dl at pre-randomization visit
boolean
C0583513 (UMLS CUI [1])
Diet therapy Maintenance | Exercise Habits Maintenance
Item
agreement to maintain diet and exercise habits during the study
boolean
C0012159 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C0018464 (UMLS CUI [2,2])
C0024501 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus | Diabetes Mellitus Due to Injury of pancreas | Complications of Diabetes Mellitus Metabolic
Item
patients with type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
boolean
C0011854 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0273163 (UMLS CUI [3,3])
C0342257 (UMLS CUI [4,1])
C0311400 (UMLS CUI [4,2])
Thiazolidinediones | Peroxisome Proliferator-Activated Receptor Agonist Dual
Item
any previous treatment with thiazolidinedione or a dual ppar agonist
boolean
C1257987 (UMLS CUI [1])
C0166418 (UMLS CUI [2,1])
C2987634 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
Weight reduction regimen | Lipoprotein modification Therapy | Exception Statins Dose Stable
Item
any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
boolean
C0311130 (UMLS CUI [1])
C1158918 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0360714 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Hypoglycemic Agents | Exception Sulfonylurea | Exception Metformin | Exception Combined Modality Therapy
Item
any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0009429 (UMLS CUI [4,2])
Symptomatic congestive heart failure New York Heart Association Classification
Item
symptomatic congestive heart failure classified as new york heart association class ii-iv at screening
boolean
C0742758 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video