ID

29152

Description

A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.; ODM derived from: https://clinicaltrials.gov/show/NCT00755287

Lien

https://clinicaltrials.gov/show/NCT00755287

Mots-clés

Versions (1)
  1. 01/03/2018 01/03/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

1 mars 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00755287

Anglais

Eligibility Diabetes Mellitus, Type 2 NCT00755287

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, 18-75 years of age;
Description

Adult | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
Description

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

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0038766
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
c-peptide (fasting) >=1.0ng/ml;
Description

Fasting C-peptide level

Type de données

boolean

Alias
UMLS CUI [1]
C2208720
hba1c >=7.0% and <=10.0% at screening;
Description

Glucohemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0202054
bmi >=25 (>23 for asians) and <=45kg/m2 at screening;
Description

Body mass index | Asians

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0078988
stable weight +-5% for at least 12 weeks prior to screening.
Description

Stable body weight Duration

Type de données

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
Description

Diabetes Mellitus, Insulin-Dependent | Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar Coma

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0342257
UMLS CUI [2,2]
C0311400
UMLS CUI [3]
C0220982
UMLS CUI [4]
C0020457
evidence of clinically significant diabetic complications;
Description

Complications of Diabetes Mellitus

Type de données

boolean

Alias
UMLS CUI [1]
C0342257
symptomatic poorly controlled diabetes;
Description

Poorly controlled diabetes mellitus Symptomatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0554876
UMLS CUI [1,2]
C0231220
clinically symptomatic gastrointestinal disease;
Description

Gastrointestinal Diseases Symptomatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0231220
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
Description

Myocardial Infarction | Coronary Artery Bypass Surgery | Cardiomyopathy Post Transplantation | Cerebrovascular accident

Type de données

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C0878544
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0040732
UMLS CUI [4]
C0038454
known hemoglobinopathy or chronic anemia.
Description

Hemoglobinopathy | Chronic anemia

Type de données

boolean

Alias
UMLS CUI [1]
C0019045
UMLS CUI [2]
C0581384
Retour au début de la page

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00755287

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, 18-75 years of age;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Dose Stable | Sulfonylurea Dose Stable
Item
type 2 diabetes treated with a stable dose of metformin and sulphonylurea for at least 12 weeks;
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0038766 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Fasting C-peptide level
Item
c-peptide (fasting) >=1.0ng/ml;
boolean
C2208720 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c >=7.0% and <=10.0% at screening;
boolean
C0202054 (UMLS CUI [1])
Body mass index | Asians
Item
bmi >=25 (>23 for asians) and <=45kg/m2 at screening;
boolean
C1305855 (UMLS CUI [1])
C0078988 (UMLS CUI [2])
Stable body weight Duration
Item
stable weight +-5% for at least 12 weeks prior to screening.
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar Coma
Item
history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
boolean
C0011854 (UMLS CUI [1])
C0342257 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
C0220982 (UMLS CUI [3])
C0020457 (UMLS CUI [4])
Complications of Diabetes Mellitus
Item
evidence of clinically significant diabetic complications;
boolean
C0342257 (UMLS CUI [1])
Poorly controlled diabetes mellitus Symptomatic
Item
symptomatic poorly controlled diabetes;
boolean
C0554876 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Gastrointestinal Diseases Symptomatic
Item
clinically symptomatic gastrointestinal disease;
boolean
C0017178 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Cardiomyopathy Post Transplantation | Cerebrovascular accident
Item
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0878544 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0040732 (UMLS CUI [3,3])
C0038454 (UMLS CUI [4])
Hemoglobinopathy | Chronic anemia
Item
known hemoglobinopathy or chronic anemia.
boolean
C0019045 (UMLS CUI [1])
C0581384 (UMLS CUI [2])
Retour au début de la page 

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