ID

33113

Descrição

Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00971659

Link

https://clinicaltrials.gov/show/NCT00971659

Palavras-chave

Versões (1)
  1. 28/11/2018 28/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

28 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00971659

Inglês

Eligibility Type 2 Diabetes NCT00971659

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects aged between 35 and 70 years, inclusive
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes with duration >6 months and <10 years
Descrição

Non-Insulin-Dependent Diabetes Mellitus Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or nph insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
Descrição

Insulin, Long-Acting | Intermediate-acting insulin | Insulin Glargine | Insulin detemir | Insulin, isophane | Metformin Dose Stable | Sulfonylureas Dose Stable | Combined Modality Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0304870
UMLS CUI [2]
C0304869
UMLS CUI [3]
C0907402
UMLS CUI [4]
C0537270
UMLS CUI [5]
C0021658
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [7,1]
C0038766
UMLS CUI [7,2]
C0178602
UMLS CUI [7,3]
C0205360
UMLS CUI [8]
C0009429
hba1c >=7.0% and <=10.0%
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
Descrição

Antihypertensive Agents Stable | Hypolipidemic Agents Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0086440
UMLS CUI [2,2]
C0205360
written informed consent
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or presence of cancer or any clinically relevant diseases
Descrição

Malignant Neoplasms | Disease Relevance Clinical

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C0205210
chronic heart failure nyha class iii or iv, unstable angina pectoris or myocardial infarction within the previous 6 months
Descrição

Chronic heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0264716
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
recurrent hypoglycemia
Descrição

Recurrent hypoglycemia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1846288
abnormal lab tests at screening (alat and/or asat >=3 times uln), creatinine >1.6 mg/dl in males and >1.4 mg/dl in females
Descrição

Laboratory test result abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased | Creatinine measurement, serum | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0079399
clinically relevant ecg findings at screening
Descrição

ECG finding Relevance Clinical

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months
Descrição

Insulin, Short-Acting | Insulin Formulation Mixed

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0356365
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0524527
UMLS CUI [2,3]
C0205430
treatment with any other oha than metformin or metformin plus sulfonylureas during the previous 3 months
Descrição

Oral hypoglycemic | Exception Metformin | Exception Sulfonylureas

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0038766
any systemic or topical treatment with drugs known to influence glucose metabolism
Descrição

Systemic therapy | Topical administration of treatment | Pharmaceutical Preparations Influence Glucose metabolism

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1515119
UMLS CUI [2]
C0001566
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C0596620
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Similar models

Eligibility Type 2 Diabetes NCT00971659

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subjects aged between 35 and 70 years, inclusive
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
type 2 diabetes with duration >6 months and <10 years
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Insulin, Long-Acting | Intermediate-acting insulin | Insulin Glargine | Insulin detemir | Insulin, isophane | Metformin Dose Stable | Sulfonylureas Dose Stable | Combined Modality Therapy
Item
for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or nph insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
boolean
C0304870 (UMLS CUI [1])
C0304869 (UMLS CUI [2])
C0907402 (UMLS CUI [3])
C0537270 (UMLS CUI [4])
C0021658 (UMLS CUI [5])
C0025598 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0038766 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C0009429 (UMLS CUI [8])
Hemoglobin A1c measurement
Item
hba1c >=7.0% and <=10.0%
boolean
C0474680 (UMLS CUI [1])
Antihypertensive Agents Stable | Hypolipidemic Agents Stable
Item
if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
boolean
C0003364 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0086440 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Disease Relevance Clinical
Item
history or presence of cancer or any clinically relevant diseases
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Chronic heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction
Item
chronic heart failure nyha class iii or iv, unstable angina pectoris or myocardial infarction within the previous 6 months
boolean
C0264716 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Recurrent hypoglycemia
Item
recurrent hypoglycemia
boolean
C1846288 (UMLS CUI [1])
Laboratory test result abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased | Creatinine measurement, serum | Gender
Item
abnormal lab tests at screening (alat and/or asat >=3 times uln), creatinine >1.6 mg/dl in males and >1.4 mg/dl in females
boolean
C0438215 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
ECG finding Relevance Clinical
Item
clinically relevant ecg findings at screening
boolean
C0438154 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Insulin, Short-Acting | Insulin Formulation Mixed
Item
treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months
boolean
C0356365 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0205430 (UMLS CUI [2,3])
Oral hypoglycemic | Exception Metformin | Exception Sulfonylureas
Item
treatment with any other oha than metformin or metformin plus sulfonylureas during the previous 3 months
boolean
C0359086 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0038766 (UMLS CUI [3,2])
Systemic therapy | Topical administration of treatment | Pharmaceutical Preparations Influence Glucose metabolism
Item
any systemic or topical treatment with drugs known to influence glucose metabolism
boolean
C1515119 (UMLS CUI [1])
C0001566 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C0596620 (UMLS CUI [3,3])
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