ID

38780

Description

Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01734785

Link

https://clinicaltrials.gov/show/NCT01734785

Keywords

Versions (1)
  1. 11/3/19 11/3/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 3, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01734785

English

Eligibility Diabetes Mellitus, Type 2 NCT01734785

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of type 2 diabetes mellitus.
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
2. male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
Description

Gender | Diet therapy | Exercise | Pretreatment Metformin Immediate Release | Metformin Dose U/day | Metformin Maximum Tolerated Dose

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C3539076
UMLS CUI [4,2]
C0025598
UMLS CUI [4,3]
C1708470
UMLS CUI [5,1]
C0025598
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0456683
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C0752079
3. hba1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
4. age 18 years or more at screening.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. body mass index lower or equal to 45 kg/m2 at screening visit.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
6. signed and dated written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
Description

Hyperglycemia Uncontrolled | Glucose level | Status post Fasting Overnight

Data type

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0428548
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0015663
UMLS CUI [3,3]
C0439583
2. use of any other antidiabetic drug (except metformin background therapy).
Description

Antidiabetics | Exception Metformin Background Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [2,3]
C1706907
UMLS CUI [2,4]
C0087111
3. acute coronary syndrome, stroke or tia within 3 months prior to informed consent.
Description

Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
4. indication of liver disease.
Description

Indication Liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0023895
5. impaired renal function.
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
6. gastrointestinal surgery.
Description

Gastrointestinal Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1]
C0524722
7. treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
Description

Anti-Obesity Agents | Treatment Resulting in Body Weight Unstable | Operative Surgical Procedures | Diet therapy Aggressive

Data type

boolean

Alias
UMLS CUI [1]
C0376607
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0005910
UMLS CUI [2,4]
C0443343
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C0012159
UMLS CUI [4,2]
C0580822
8. current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.
Description

Systemic steroids | Endocrine System Disease Uncontrolled | Exception Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2,1]
C0014130
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011860
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01734785

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. diagnosis of type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
Gender | Diet therapy | Exercise | Pretreatment Metformin Immediate Release | Metformin Dose U/day | Metformin Maximum Tolerated Dose
Item
2. male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
boolean
C0079399 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C3539076 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
C1708470 (UMLS CUI [4,3])
C0025598 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
C0025598 (UMLS CUI [6,1])
C0752079 (UMLS CUI [6,2])
Hemoglobin A1c measurement
Item
3. hba1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
boolean
C0474680 (UMLS CUI [1])
Age
Item
4. age 18 years or more at screening.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
5. body mass index lower or equal to 45 kg/m2 at screening visit.
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
6. signed and dated written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyperglycemia Uncontrolled | Glucose level | Status post Fasting Overnight
Item
1. uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0015663 (UMLS CUI [3,2])
C0439583 (UMLS CUI [3,3])
Antidiabetics | Exception Metformin Background Therapy
Item
2. use of any other antidiabetic drug (except metformin background therapy).
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1706907 (UMLS CUI [2,3])
C0087111 (UMLS CUI [2,4])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack
Item
3. acute coronary syndrome, stroke or tia within 3 months prior to informed consent.
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Indication Liver disease
Item
4. indication of liver disease.
boolean
C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
Renal Insufficiency
Item
5. impaired renal function.
boolean
C1565489 (UMLS CUI [1])
Gastrointestinal Surgical Procedure
Item
6. gastrointestinal surgery.
boolean
C0524722 (UMLS CUI [1])
Anti-Obesity Agents | Treatment Resulting in Body Weight Unstable | Operative Surgical Procedures | Diet therapy Aggressive
Item
7. treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
boolean
C0376607 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0005910 (UMLS CUI [2,3])
C0443343 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3])
C0012159 (UMLS CUI [4,1])
C0580822 (UMLS CUI [4,2])
Systemic steroids | Endocrine System Disease Uncontrolled | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
8. current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.
boolean
C2825233 (UMLS CUI [1])
C0014130 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0011860 (UMLS CUI [3,2])
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