ID

38808

Beschrijving

The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study; ODM derived from: https://clinicaltrials.gov/show/NCT01966978

Link

https://clinicaltrials.gov/show/NCT01966978

Trefwoorden

Versies (1)
  1. 05-11-19 05-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 november 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes Mellitus, Type 2 NCT01966978

Engels

Eligibility Diabetes Mellitus, Type 2 NCT01966978

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. clinical diagnosis of type 2 diabetes with confirmed hba1c level >10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age <18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Medical contraindication Mealtime Insulin

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0587119
UMLS CUI [2,3]
C0021641
3. clinical state requiring inpatient admission/treatment;
Beschrijving

Clinical state Requirement Hospital admission | Clinical state Requirement Inpatient treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0457936
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0184666
UMLS CUI [2,1]
C0457936
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0019993
4. contraindication or strong cautions to any of the study medications:
Beschrijving

Medical contraindication Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
1. creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)
Beschrijving

Creatinine measurement, serum | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
2. history of lactic acidosis (per metformin label)
Beschrijving

Acidosis, Lactic

Datatype

boolean

Alias
UMLS CUI [1]
C0001125
3. advanced hepatic or cardiac disease (per metformin label)
Beschrijving

Liver disease Advanced | Heart Disease Advanced

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205179
4. age >80 years (per metformin label)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. chronic alcohol use (>14 drinks/week)
Beschrijving

Alcohol consumption chronic | Drinks per week

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0001967
UMLS CUI [2,2]
C0332174
6. history of pancreatitis (per liraglutide label)
Beschrijving

Pancreatitis

Datatype

boolean

Alias
UMLS CUI [1]
C0030305
7. personal or family history of medullary thyroid cancer or men syndrome (per liraglutide label)
Beschrijving

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia

Datatype

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3]
C0027662
8. pregnancy and lactation (per liraglutide label)
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;
Beschrijving

Medical condition Serious Interferes with Therapeutic procedure | Medical condition Unstable Interferes with Therapeutic procedure | Medical condition Serious Interferes with Outcome Measurement | Medical condition Unstable Interferes with Outcome Measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0087111
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C2985619
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C2985619
6. any scheduled elective procedures/surgeries;
Beschrijving

Elective procedure Scheduled | Elective Surgical Procedures Scheduled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0747973
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0206058
UMLS CUI [2,2]
C0205539
7. active infections, including osteomyelitis;
Beschrijving

Communicable Diseases | Osteomyelitis

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0029443
8. not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to randomization (visit 1)and the week prior to visit 6
Beschrijving

Participation Unwilling | Protocol Compliance Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
9. non english speaking.
Beschrijving

Lacking Able to speak English Language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
Terug naar het begin van de pagina

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01966978

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
1. clinical diagnosis of type 2 diabetes with confirmed hba1c level >10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age <18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Medical contraindication Mealtime Insulin
Item
2. type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
boolean
C0011854 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0587119 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Clinical state Requirement Hospital admission | Clinical state Requirement Inpatient treatment
Item
3. clinical state requiring inpatient admission/treatment;
boolean
C0457936 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,3])
C0457936 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0019993 (UMLS CUI [2,3])
Medical contraindication Investigational New Drugs
Item
4. contraindication or strong cautions to any of the study medications:
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Creatinine measurement, serum | Gender
Item
1. creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Acidosis, Lactic
Item
2. history of lactic acidosis (per metformin label)
boolean
C0001125 (UMLS CUI [1])
Liver disease Advanced | Heart Disease Advanced
Item
3. advanced hepatic or cardiac disease (per metformin label)
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
Age
Item
4. age >80 years (per metformin label)
boolean
C0001779 (UMLS CUI [1])
Alcohol consumption chronic | Drinks per week
Item
5. chronic alcohol use (>14 drinks/week)
boolean
C0001948 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001967 (UMLS CUI [2,1])
C0332174 (UMLS CUI [2,2])
Pancreatitis
Item
6. history of pancreatitis (per liraglutide label)
boolean
C0030305 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia
Item
7. personal or family history of medullary thyroid cancer or men syndrome (per liraglutide label)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
8. pregnancy and lactation (per liraglutide label)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Serious Interferes with Therapeutic procedure | Medical condition Unstable Interferes with Therapeutic procedure | Medical condition Serious Interferes with Outcome Measurement | Medical condition Unstable Interferes with Outcome Measurement
Item
5. any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C2985619 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C2985619 (UMLS CUI [4,4])
Elective procedure Scheduled | Elective Surgical Procedures Scheduled
Item
6. any scheduled elective procedures/surgeries;
boolean
C0747973 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0206058 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Communicable Diseases | Osteomyelitis
Item
7. active infections, including osteomyelitis;
boolean
C0009450 (UMLS CUI [1])
C0029443 (UMLS CUI [2])
Participation Unwilling | Protocol Compliance Unwilling
Item
8. not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to randomization (visit 1)and the week prior to visit 6
boolean
C0679823 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Lacking Able to speak English Language
Item
9. non english speaking.
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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