ID

38808

Description

The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study; ODM derived from: https://clinicaltrials.gov/show/NCT01966978

Link

https://clinicaltrials.gov/show/NCT01966978

Keywords

Versions (1)
  1. 11/5/19 11/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01966978

English

Eligibility Diabetes Mellitus, Type 2 NCT01966978

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. clinical diagnosis of type 2 diabetes with confirmed hba1c level >10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age <18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
Description

Diabetes Mellitus, Insulin-Dependent | Medical contraindication Mealtime Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0587119
UMLS CUI [2,3]
C0021641
3. clinical state requiring inpatient admission/treatment;
Description

Clinical state Requirement Hospital admission | Clinical state Requirement Inpatient treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0457936
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0184666
UMLS CUI [2,1]
C0457936
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0019993
4. contraindication or strong cautions to any of the study medications:
Description

Medical contraindication Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
1. creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)
Description

Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
2. history of lactic acidosis (per metformin label)
Description

Acidosis, Lactic

Data type

boolean

Alias
UMLS CUI [1]
C0001125
3. advanced hepatic or cardiac disease (per metformin label)
Description

Liver disease Advanced | Heart Disease Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205179
4. age >80 years (per metformin label)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. chronic alcohol use (>14 drinks/week)
Description

Alcohol consumption chronic | Drinks per week

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0001967
UMLS CUI [2,2]
C0332174
6. history of pancreatitis (per liraglutide label)
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
7. personal or family history of medullary thyroid cancer or men syndrome (per liraglutide label)
Description

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia

Data type

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3]
C0027662
8. pregnancy and lactation (per liraglutide label)
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;
Description

Medical condition Serious Interferes with Therapeutic procedure | Medical condition Unstable Interferes with Therapeutic procedure | Medical condition Serious Interferes with Outcome Measurement | Medical condition Unstable Interferes with Outcome Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0087111
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C2985619
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C2985619
6. any scheduled elective procedures/surgeries;
Description

Elective procedure Scheduled | Elective Surgical Procedures Scheduled

Data type

boolean

Alias
UMLS CUI [1,1]
C0747973
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C0206058
UMLS CUI [2,2]
C0205539
7. active infections, including osteomyelitis;
Description

Communicable Diseases | Osteomyelitis

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0029443
8. not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to randomization (visit 1)and the week prior to visit 6
Description

Participation Unwilling | Protocol Compliance Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0558080
9. non english speaking.
Description

Lacking Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01966978

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
1. clinical diagnosis of type 2 diabetes with confirmed hba1c level >10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age <18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent | Medical contraindication Mealtime Insulin
Item
2. type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
boolean
C0011854 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0587119 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Clinical state Requirement Hospital admission | Clinical state Requirement Inpatient treatment
Item
3. clinical state requiring inpatient admission/treatment;
boolean
C0457936 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,3])
C0457936 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0019993 (UMLS CUI [2,3])
Medical contraindication Investigational New Drugs
Item
4. contraindication or strong cautions to any of the study medications:
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Creatinine measurement, serum | Gender
Item
1. creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Acidosis, Lactic
Item
2. history of lactic acidosis (per metformin label)
boolean
C0001125 (UMLS CUI [1])
Liver disease Advanced | Heart Disease Advanced
Item
3. advanced hepatic or cardiac disease (per metformin label)
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
Age
Item
4. age >80 years (per metformin label)
boolean
C0001779 (UMLS CUI [1])
Alcohol consumption chronic | Drinks per week
Item
5. chronic alcohol use (>14 drinks/week)
boolean
C0001948 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001967 (UMLS CUI [2,1])
C0332174 (UMLS CUI [2,2])
Pancreatitis
Item
6. history of pancreatitis (per liraglutide label)
boolean
C0030305 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia
Item
7. personal or family history of medullary thyroid cancer or men syndrome (per liraglutide label)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
8. pregnancy and lactation (per liraglutide label)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Serious Interferes with Therapeutic procedure | Medical condition Unstable Interferes with Therapeutic procedure | Medical condition Serious Interferes with Outcome Measurement | Medical condition Unstable Interferes with Outcome Measurement
Item
5. any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C2985619 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C2985619 (UMLS CUI [4,4])
Elective procedure Scheduled | Elective Surgical Procedures Scheduled
Item
6. any scheduled elective procedures/surgeries;
boolean
C0747973 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0206058 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Communicable Diseases | Osteomyelitis
Item
7. active infections, including osteomyelitis;
boolean
C0009450 (UMLS CUI [1])
C0029443 (UMLS CUI [2])
Participation Unwilling | Protocol Compliance Unwilling
Item
8. not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to randomization (visit 1)and the week prior to visit 6
boolean
C0679823 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Lacking Able to speak English Language
Item
9. non english speaking.
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
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