ID

29153

Beschreibung

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

Stichworte

Versionen (1)
  1. 01.03.18 01.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. März 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00767000

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00767000

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
has type 2 diabetes mellitus
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

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

Body mass index

Datentyp

boolean

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

Gender | Pregnancy Unlikely

Datentyp

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
Beschreibung

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

Datentyp

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:
Beschreibung

Extension Clinical Trial | Inclusion criteria

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis

Datentyp

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
Beschreibung

Thiazolidinediones | pioglitazone | rosiglitazone | Incretins Injectable | Byetta

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Operative Surgical Procedures | Major surgery Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C1301732
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00767000

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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