ID

32936

Description

Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01003184

Lien

https://clinicaltrials.gov/show/NCT01003184

Mots-clés

Versions (1)
  1. 21/11/2018 21/11/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

21 novembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01003184

Anglais

Eligibility Type 2 Diabetes Mellitus NCT01003184

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have suboptimal glycaemic control as evidenced by an hba1c 7.1% to 10.0%, inclusive
Description

Glycaemia control Suboptimal | Hemoglobin A1c measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C3267174
UMLS CUI [1,2]
C2984009
UMLS CUI [2]
C0474680
have a body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start or are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start
Description

Metformin Dose Stable | Sulfonylurea Dose Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have any contraindication for the oad that they have been using
Description

Medical contraindication Antidiabetics Oral

Type de données

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0935929
UMLS CUI [1,3]
C1527415
have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
Description

Hypersensitivity Insulin detemir | Hypersensitivity Exenatide | Hypersensitivity Insulin detemir Excipient | Hypersensitivity Exenatide Excipient

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0537270
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0167117
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0537270
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0167117
UMLS CUI [4,3]
C0015237
have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (iv) or intramuscular (im) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. addison disease)
Description

Systemic Glucocorticoids Oral | Systemic Glucocorticoids Intravenous | Systemic Glucocorticoids Intramuscular | Inhaled steroids Intranasal | Exception Hypopituitarism | Exception Addison Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C3540777
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C3540777
UMLS CUI [3,2]
C1556154
UMLS CUI [4,1]
C2065041
UMLS CUI [4,2]
C0442118
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0020635
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0001403
have been treated with drugs that promote weight loss, within 3 months of screening
Description

Weight-Loss Agents

Type de données

boolean

Alias
UMLS CUI [1]
C0376606
have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, byetta®
Description

Insulin | Alpha-glucosidase | Byetta

Type de données

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0002272
UMLS CUI [3]
C1636686
(exenatide bid formulation), thiazolidinediones (tzd), dipeptidyl peptidase (dpp)-4 inhibitors
Description

Exenatide Twice a day | Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors

Type de données

boolean

Alias
UMLS CUI [1,1]
C0167117
UMLS CUI [1,2]
C0585361
UMLS CUI [2]
C1257987
UMLS CUI [3]
C1827106
have previously completed or withdrawn from this study or any other study investigating exenatide qw
Description

Study Subject Participation Status | Completion of clinical trial | Patient withdrawn from trial | Exenatide Once a week

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2732579
UMLS CUI [3]
C0422727
UMLS CUI [4,1]
C0167117
UMLS CUI [4,2]
C0558293
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Description

Pharmaceutical Preparations Approval Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0162696
UMLS CUI [1,3]
C0332268
are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Description

Study Subject Participation Status | Investigational New Drugs Off-label | Investigational Medical Device Off-label

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C2986467
UMLS CUI [3,1]
C2346570
UMLS CUI [3,2]
C2986467
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01003184

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Glycaemia control Suboptimal | Hemoglobin A1c measurement
Item
have suboptimal glycaemic control as evidenced by an hba1c 7.1% to 10.0%, inclusive
boolean
C3267174 (UMLS CUI [1,1])
C2984009 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
Body mass index
Item
have a body mass index (bmi) of 25 kg/m2 to 45 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Metformin Dose Stable | Sulfonylurea Dose Stable
Item
are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start or are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Antidiabetics Oral
Item
have any contraindication for the oad that they have been using
boolean
C1301624 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
Hypersensitivity Insulin detemir | Hypersensitivity Exenatide | Hypersensitivity Insulin detemir Excipient | Hypersensitivity Exenatide Excipient
Item
have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
boolean
C0020517 (UMLS CUI [1,1])
C0537270 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0167117 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0537270 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0167117 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Systemic Glucocorticoids Oral | Systemic Glucocorticoids Intravenous | Systemic Glucocorticoids Intramuscular | Inhaled steroids Intranasal | Exception Hypopituitarism | Exception Addison Disease
Item
have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (iv) or intramuscular (im) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. addison disease)
boolean
C3540777 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3540777 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C3540777 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4,1])
C0442118 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0020635 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0001403 (UMLS CUI [6,2])
Weight-Loss Agents
Item
have been treated with drugs that promote weight loss, within 3 months of screening
boolean
C0376606 (UMLS CUI [1])
Insulin | Alpha-glucosidase | Byetta
Item
have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, byetta®
boolean
C0021641 (UMLS CUI [1])
C0002272 (UMLS CUI [2])
C1636686 (UMLS CUI [3])
Exenatide Twice a day | Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors
Item
(exenatide bid formulation), thiazolidinediones (tzd), dipeptidyl peptidase (dpp)-4 inhibitors
boolean
C0167117 (UMLS CUI [1,1])
C0585361 (UMLS CUI [1,2])
C1257987 (UMLS CUI [2])
C1827106 (UMLS CUI [3])
Study Subject Participation Status | Completion of clinical trial | Patient withdrawn from trial | Exenatide Once a week
Item
have previously completed or withdrawn from this study or any other study investigating exenatide qw
boolean
C2348568 (UMLS CUI [1])
C2732579 (UMLS CUI [2])
C0422727 (UMLS CUI [3])
C0167117 (UMLS CUI [4,1])
C0558293 (UMLS CUI [4,2])
Pharmaceutical Preparations Approval Lacking
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
boolean
C0013227 (UMLS CUI [1,1])
C0162696 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs Off-label | Investigational Medical Device Off-label
Item
are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C2986467 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3,1])
C2986467 (UMLS CUI [3,2])
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