ID

37396

Description

Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02455076

Link

https://clinicaltrials.gov/show/NCT02455076

Keywords

Versions (1)
  1. 7/22/19 7/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02455076

English

Eligibility Type 2 Diabetes NCT02455076

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. a known history of type 2 diabetes receiving either diet alone or oral antidiabetic drugs (oad) including insulin secretagogues, pioglitazone, dpp4 inhibitors, or metformin as monotherapy or in combination therapy, or low-dose insulin at <0.5 unit/kg/day.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Antidiabetics Oral | Pills Insulin Releasing | pioglitazone | Dipeptidyl-Peptidase IV Inhibitors | Metformin | Combined Modality Therapy | Insulin Low dose U/kg/day

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0994475
UMLS CUI [4,2]
C0021641
UMLS CUI [4,3]
C1283071
UMLS CUI [5]
C0071097
UMLS CUI [6]
C1827106
UMLS CUI [7]
C0025598
UMLS CUI [8]
C0009429
UMLS CUI [9,1]
C0021641
UMLS CUI [9,2]
C0445550
UMLS CUI [9,3]
C1532634
2. males or females between the ages of 18 and 80 years discharged after hospital admission from general medicine and surgery services (non-intensive care unit setting).
Description

Age | Patient Discharge Post Hospital admission

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0030685
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0184666
3. subjects with an admission / randomization bg < 400 mg/dl without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 meq/l or positive serum or urinary ketones).
Description

Blood glucose measurement | Diabetic Ketoacidosis Absent | Serum bicarbonate measurement | Serum ketones Positive | Urine ketone test Positive

Data type

boolean

Alias
UMLS CUI [1]
C0392201
UMLS CUI [2,1]
C0011880
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0428301
UMLS CUI [4,1]
C0036812
UMLS CUI [4,2]
C1514241
UMLS CUI [5,1]
C0555179
UMLS CUI [5,2]
C1514241
4. admission hba1c between 7% and 10%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
5. bmi range: > 25 kg/m^2 and < 45 kg/m^2
Description

Body mass index Range

Data type

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C1514721
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age < 18 or > 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. subjects with increased blood glucose (bg) concentration, but without a history of diabetes (stress hyperglycemia)
Description

Blood glucose increased | Diabetes Mellitus Absent | Stress induced hyperglycaemia

Data type

boolean

Alias
UMLS CUI [1]
C0595877
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0856953
3. subjects with a history of type 1 diabetes (suggested by bmi < 25 kg/m^2 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria).
Description

Diabetes Mellitus, Insulin-Dependent | Body mass index | Patient need for Insulin regime | Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State | Ketonuria

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C1305855
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0557978
UMLS CUI [4]
C0011880
UMLS CUI [5]
C3888846
UMLS CUI [6]
C0162275
4. treatment with high-dose (>0.5 unit/kg/day) insulin or with glp-1 ra during the past 3 months prior to admission.
Description

Insulin High dose U/kg/day | GLP-1 Receptor Agonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0444956
UMLS CUI [1,3]
C1532634
UMLS CUI [2]
C2917359
5. patients that required icu care during the hospital admission.
Description

Care of intensive care unit patient | Hospital admission

Data type

boolean

Alias
UMLS CUI [1]
C0010337
UMLS CUI [2]
C0184666
6. recurrent severe hypoglycemia or hypoglycemic unawareness.
Description

Recurrent severe hypoglycemia | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
7. subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or those expected to require gastrointestinal suction.
Description

Gastrointestinal obstruction | Gastroparesis | Pancreatitis | Suction gastrointestinal expected

Data type

boolean

Alias
UMLS CUI [1]
C0236124
UMLS CUI [2]
C0152020
UMLS CUI [3]
C0030305
UMLS CUI [4,1]
C0038638
UMLS CUI [4,2]
C0521362
UMLS CUI [4,3]
C1517001
8. patients with clinically relevant pancreatic or gallbladder disease.
Description

Pancreatic Disease | Gall Bladder Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030286
UMLS CUI [2]
C0016977
9. patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
Description

Kidney Disease Unstable | Kidney Disease Rapidly progressive | Renal Insufficiency Severe | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C1838681
UMLS CUI [3,1]
C1565489
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0373595
10. patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease),
Description

Liver disease | Liver Cirrhosis | Icterus | End Stage Liver Disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0022346
UMLS CUI [4]
C0745744
11. history of hypersensitivity to exenatide
Description

Hypersensitivity Exenatide

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0167117
12. treatment with oral or injectable corticosteroid (equal to a prednisone dose >5 mg/day), parenteral nutrition and immunosuppressive treatment.
Description

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable | Equivalent Prednisone Dose U/day | Parenteral Nutrition | Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1828121
UMLS CUI [3,1]
C0205163
UMLS CUI [3,2]
C0032952
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0456683
UMLS CUI [4]
C0030547
UMLS CUI [5]
C0021079
13. patients with history of heavy alcohol use (female > 2 drinks per day, male > 3 drinks per day) or drug abuse within 3 months prior to admission.
Description

Heavy alcohol use Drinks per day | Gender | Drug abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0687132
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0439505
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0013146
14. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Description

Mental handicap | Study Protocol Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C1299582
15. female subjects who are pregnant or breast feeding at time of enrollment into the study.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Type 2 Diabetes NCT02455076

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Antidiabetics Oral | Pills Insulin Releasing | pioglitazone | Dipeptidyl-Peptidase IV Inhibitors | Metformin | Combined Modality Therapy | Insulin Low dose U/kg/day
Item
1. a known history of type 2 diabetes receiving either diet alone or oral antidiabetic drugs (oad) including insulin secretagogues, pioglitazone, dpp4 inhibitors, or metformin as monotherapy or in combination therapy, or low-dose insulin at <0.5 unit/kg/day.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0994475 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])
C1283071 (UMLS CUI [4,3])
C0071097 (UMLS CUI [5])
C1827106 (UMLS CUI [6])
C0025598 (UMLS CUI [7])
C0009429 (UMLS CUI [8])
C0021641 (UMLS CUI [9,1])
C0445550 (UMLS CUI [9,2])
C1532634 (UMLS CUI [9,3])
Age | Patient Discharge Post Hospital admission
Item
2. males or females between the ages of 18 and 80 years discharged after hospital admission from general medicine and surgery services (non-intensive care unit setting).
boolean
C0001779 (UMLS CUI [1])
C0030685 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0184666 (UMLS CUI [2,3])
Blood glucose measurement | Diabetic Ketoacidosis Absent | Serum bicarbonate measurement | Serum ketones Positive | Urine ketone test Positive
Item
3. subjects with an admission / randomization bg < 400 mg/dl without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 meq/l or positive serum or urinary ketones).
boolean
C0392201 (UMLS CUI [1])
C0011880 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0428301 (UMLS CUI [3])
C0036812 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
C0555179 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
Hemoglobin A1c measurement
Item
4. admission hba1c between 7% and 10%
boolean
C0474680 (UMLS CUI [1])
Body mass index Range
Item
5. bmi range: > 25 kg/m^2 and < 45 kg/m^2
boolean
C1305855 (UMLS CUI [1,1])
C1514721 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
1. age < 18 or > 80 years
boolean
C0001779 (UMLS CUI [1])
Blood glucose increased | Diabetes Mellitus Absent | Stress induced hyperglycaemia
Item
2. subjects with increased blood glucose (bg) concentration, but without a history of diabetes (stress hyperglycemia)
boolean
C0595877 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0856953 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Body mass index | Patient need for Insulin regime | Diabetic Ketoacidosis | Hyperosmolar Hyperglycemic State | Ketonuria
Item
3. subjects with a history of type 1 diabetes (suggested by bmi < 25 kg/m^2 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria).
boolean
C0011854 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0557978 (UMLS CUI [3,2])
C0011880 (UMLS CUI [4])
C3888846 (UMLS CUI [5])
C0162275 (UMLS CUI [6])
Insulin High dose U/kg/day | GLP-1 Receptor Agonist
Item
4. treatment with high-dose (>0.5 unit/kg/day) insulin or with glp-1 ra during the past 3 months prior to admission.
boolean
C0021641 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C1532634 (UMLS CUI [1,3])
C2917359 (UMLS CUI [2])
Care of intensive care unit patient | Hospital admission
Item
5. patients that required icu care during the hospital admission.
boolean
C0010337 (UMLS CUI [1])
C0184666 (UMLS CUI [2])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
6. recurrent severe hypoglycemia or hypoglycemic unawareness.
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Gastrointestinal obstruction | Gastroparesis | Pancreatitis | Suction gastrointestinal expected
Item
7. subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or those expected to require gastrointestinal suction.
boolean
C0236124 (UMLS CUI [1])
C0152020 (UMLS CUI [2])
C0030305 (UMLS CUI [3])
C0038638 (UMLS CUI [4,1])
C0521362 (UMLS CUI [4,2])
C1517001 (UMLS CUI [4,3])
Pancreatic Disease | Gall Bladder Disease
Item
8. patients with clinically relevant pancreatic or gallbladder disease.
boolean
C0030286 (UMLS CUI [1])
C0016977 (UMLS CUI [2])
Kidney Disease Unstable | Kidney Disease Rapidly progressive | Renal Insufficiency Severe | Creatinine clearance measurement
Item
9. patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
boolean
C0022658 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C1838681 (UMLS CUI [2,2])
C1565489 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0373595 (UMLS CUI [4])
Liver disease | Liver Cirrhosis | Icterus | End Stage Liver Disease
Item
10. patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease),
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0022346 (UMLS CUI [3])
C0745744 (UMLS CUI [4])
Hypersensitivity Exenatide
Item
11. history of hypersensitivity to exenatide
boolean
C0020517 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable | Equivalent Prednisone Dose U/day | Parenteral Nutrition | Therapeutic immunosuppression
Item
12. treatment with oral or injectable corticosteroid (equal to a prednisone dose >5 mg/day), parenteral nutrition and immunosuppressive treatment.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3,1])
C0032952 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
C0030547 (UMLS CUI [4])
C0021079 (UMLS CUI [5])
Heavy alcohol use Drinks per day | Gender | Drug abuse
Item
13. patients with history of heavy alcohol use (female > 2 drinks per day, male > 3 drinks per day) or drug abuse within 3 months prior to admission.
boolean
C0687132 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
C0013146 (UMLS CUI [3])
Mental handicap | Study Protocol Comprehension Unable
Item
14. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
boolean
C1306341 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
15. female subjects who are pregnant or breast feeding at time of enrollment into the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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