ID

38846

Description

Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00909480

Lien

https://clinicaltrials.gov/show/NCT00909480

Mots-clés

Versions (1)
  1. 09/11/2019 09/11/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

9 novembre 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Diabetes NCT00909480

Anglais

Eligibility Diabetes NCT00909480

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00909480
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes for at least 6 months
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other oad (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (dpp-4) inhibitors) for at least 3 months
Description

Treatment Stable | Metformin Cumulative Dose U/day | Metformin Maximum Tolerated Dose | Antidiabetics Oral Quantity | Antidiabetics Oral Absent | Sulfonylureas | Meglitinides | Thiazolidinediones | Dipeptidyl Peptidase 4 Inhibitors

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C2986497
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0752079
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C1527415
UMLS CUI [5,3]
C0332197
UMLS CUI [6]
C0038766
UMLS CUI [7]
C1579432
UMLS CUI [8]
C1257987
UMLS CUI [9]
C2917254
subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
Description

Insulin Absent | Insulin regime short-term allowed

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
hba1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
Description

Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) less than or equal to 35.0 kg/m^2
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindication to insulin detemir or insulin glargine according to the local labelling
Description

Medical contraindication insulin detemir | Medical contraindication Insulin Glargine

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0537270
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0907402
receipt of any investigational product within 4 weeks
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
Description

Systemic therapy Dose Change | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE

Type de données

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392747
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0596620
UMLS CUI [3]
C3653708
clinically significant diseases which, in the investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
Description

Disease Clinical Significance Interferes with Research results | Disease Clinical Significance Investigational New Drugs At risk

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0683954
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C1444641
any other condition that the investigator feels would interfere with trial participation or evaluation of results
Description

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
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Similar models

Eligibility Diabetes NCT00909480

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00909480
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Treatment Stable | Metformin Cumulative Dose U/day | Metformin Maximum Tolerated Dose | Antidiabetics Oral Quantity | Antidiabetics Oral Absent | Sulfonylureas | Meglitinides | Thiazolidinediones | Dipeptidyl Peptidase 4 Inhibitors
Item
stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other oad (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (dpp-4) inhibitors) for at least 3 months
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0038766 (UMLS CUI [6])
C1579432 (UMLS CUI [7])
C1257987 (UMLS CUI [8])
C2917254 (UMLS CUI [9])
Insulin Absent | Insulin regime short-term allowed
Item
subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) less than or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication insulin detemir | Medical contraindication Insulin Glargine
Item
any contraindication to insulin detemir or insulin glargine according to the local labelling
boolean
C1301624 (UMLS CUI [1,1])
C0537270 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
Investigational New Drugs
Item
receipt of any investigational product within 4 weeks
boolean
C0013230 (UMLS CUI [1])
Systemic therapy Dose Change | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
boolean
C1515119 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C3653708 (UMLS CUI [3])
Disease Clinical Significance Interferes with Research results | Disease Clinical Significance Investigational New Drugs At risk
Item
clinically significant diseases which, in the investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
any other condition that the investigator feels would interfere with trial participation or evaluation of results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
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