ID

29153

Beschrijving

Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED); ODM derived from: https://clinicaltrials.gov/show/NCT00767000

Link

https://clinicaltrials.gov/show/NCT00767000

Trefwoorden

Versies (1)
  1. 01-03-18 01-03-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

1 maart 2018

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 NCT00767000

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00767000

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
has type 2 diabetes mellitus
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
has body mass index >20 and <43 kg/m^2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
is a male, or a female who is unlikely to conceive
Beschrijving

Gender | Pregnancy Unlikely

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0750558
currently on a stable dose of insulin with or without metformin for type 2 diabetes mellitus
Beschrijving

Insulin Dose Stable | Metformin | Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0011860
extension study inclusion criteria:
Beschrijving

Extension Clinical Trial | Inclusion criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231448
UMLS CUI [1,2]
C0008976
UMLS CUI [2]
C1512693
completed the base study either on double-blind study medication or as part of the post-treatment follow up population
Beschrijving

Base Clinical Trial Completed | Double-Blind Method Pharmaceutical Preparations | Follow-up Population post treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C1705938
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0013072
UMLS CUI [2,2]
C0013227
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C1257890
UMLS CUI [3,3]
C2709088
had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period
Beschrijving

Compliance Percentage Double-Blind Method Pharmaceutical Preparations | Compliance Percentage Open Label Pharmaceutical Preparations

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0013072
UMLS CUI [1,4]
C0013227
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C1709323
UMLS CUI [2,4]
C0013227
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
has any history of type 1 diabetes mellitus or ketoacidosis
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as byetta) within the prior 8 weeks
Beschrijving

Thiazolidinediones | pioglitazone | rosiglitazone | Incretins Injectable | Byetta

Datatype

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0071097
UMLS CUI [3]
C0289313
UMLS CUI [4,1]
C1562292
UMLS CUI [4,2]
C0086466
UMLS CUI [5]
C1636686
has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
Beschrijving

Episode Quantity Resulting in Hypoglycemic seizures | Episode Quantity Resulting in Coma | Episode Quantity Resulting in Unconscious State

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332294
UMLS CUI [1,4]
C0877056
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332294
UMLS CUI [2,4]
C0009421
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0332294
UMLS CUI [3,4]
C0041657
is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of visit 1
Beschrijving

Weight Reduction Programs | Maintenance Phase Absent | Weight-Loss Agents | orlistat | sibutramine | rimonabant

Datatype

boolean

Alias
UMLS CUI [1]
C3179079
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0205390
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0376606
UMLS CUI [4]
C0076275
UMLS CUI [5]
C0074493
UMLS CUI [6]
C1142933
has undergone surgery within 30 days prior to visit 1 or has planned major surgery
Beschrijving

Operative Surgical Procedures | Major surgery Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C1301732
Terug naar het begin van de pagina

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00767000

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
has type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Body mass index
Item
has body mass index >20 and <43 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Gender | Pregnancy Unlikely
Item
is a male, or a female who is unlikely to conceive
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
Insulin Dose Stable | Metformin | Diabetes Mellitus, Non-Insulin-Dependent
Item
currently on a stable dose of insulin with or without metformin for type 2 diabetes mellitus
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Extension Clinical Trial | Inclusion criteria
Item
extension study inclusion criteria:
boolean
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
Base Clinical Trial Completed | Double-Blind Method Pharmaceutical Preparations | Follow-up Population post treatment
Item
completed the base study either on double-blind study medication or as part of the post-treatment follow up population
boolean
C1705938 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0013072 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C3274571 (UMLS CUI [3,1])
C1257890 (UMLS CUI [3,2])
C2709088 (UMLS CUI [3,3])
Compliance Percentage Double-Blind Method Pharmaceutical Preparations | Compliance Percentage Open Label Pharmaceutical Preparations
Item
had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period
boolean
C1321605 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0013072 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C1321605 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1709323 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis
Item
has any history of type 1 diabetes mellitus or ketoacidosis
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
Thiazolidinediones | pioglitazone | rosiglitazone | Incretins Injectable | Byetta
Item
has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as byetta) within the prior 8 weeks
boolean
C1257987 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
C0289313 (UMLS CUI [3])
C1562292 (UMLS CUI [4,1])
C0086466 (UMLS CUI [4,2])
C1636686 (UMLS CUI [5])
Episode Quantity Resulting in Hypoglycemic seizures | Episode Quantity Resulting in Coma | Episode Quantity Resulting in Unconscious State
Item
has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332294 (UMLS CUI [1,3])
C0877056 (UMLS CUI [1,4])
C0332189 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332294 (UMLS CUI [2,3])
C0009421 (UMLS CUI [2,4])
C0332189 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332294 (UMLS CUI [3,3])
C0041657 (UMLS CUI [3,4])
Weight Reduction Programs | Maintenance Phase Absent | Weight-Loss Agents | orlistat | sibutramine | rimonabant
Item
is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of visit 1
boolean
C3179079 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0376606 (UMLS CUI [3])
C0076275 (UMLS CUI [4])
C0074493 (UMLS CUI [5])
C1142933 (UMLS CUI [6])
Operative Surgical Procedures | Major surgery Planned
Item
has undergone surgery within 30 days prior to visit 1 or has planned major surgery
boolean
C0543467 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
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