ID

20618

Description

Local Registration Trial in China Humalog Mix 50; ODM derived from: https://clinicaltrials.gov/show/NCT00191581

Link

https://clinicaltrials.gov/show/NCT00191581

Keywords

Versions (1)
  1. 3/6/17 3/6/17 -
Uploaded on

March 6, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00191581

English

Eligibility Diabetes Mellitus, Type 1 NCT00191581

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women who have had either type 1 or type 2 diabetes (world health organization[who]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent.
Description

Age | Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus disease length

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C0872146
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C0872146
2. have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study.
Description

Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0557978
3. have an hba1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at visit 1.
Description

Increased HbA1c levels

Data type

boolean

Alias
UMLS CUI [1]
C4073162
4. have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
Description

Compliance behavior | Diet therapy | Insulin regime | Blood Glucose Self-Monitoring

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0557978
UMLS CUI [4]
C0005803
5. have given informed consent to participate in this study in accordance with local regulations.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
{1] have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study.
Description

Antidiabetics Oral | Biguanides | Sulfonylurea Compounds | Glucosidase Inhibitor | Enhanced insulin sensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0005382
UMLS CUI [3]
C0038766
UMLS CUI [4]
C1512211
UMLS CUI [5]
C3549878
[2] receive a total daily dose of insulin >2 units/kg.
Description

Insulin Cumulative Dose Unit/kilogram/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C1532634
[3] have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study.
Description

Hypoglycemia Severe Episode Quantity | Hypoglycemia Disabling Requirement Assistance

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C4061999
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C1269765
[4] have a body mass index >35 kg/m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
[5] have serum creatinine > the upper limit of normal (uln), as determined by a local laboratory.
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00191581

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus disease length
Item
1. men and women who have had either type 1 or type 2 diabetes (world health organization[who]classification)for at least 2 months and are between the ages of 18 and 70 (inclusive) at the signing of the informed consent.
boolean
C0001779 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
Insulin regime
Item
2. have been treated with commercially available human insulin mix 50/50 or human insulin mix 30/70 twice daily as the only pharmacological treatment for their diabetes for at least 2 months prior to entering the study.
boolean
C0557978 (UMLS CUI [1])
Increased HbA1c levels
Item
3. have an hba1c between 1.1 and 1.7 times the upper limit of the normal reference rang(inclusive) as determined by a local laboratory within 2 weeks prior to or at visit 1.
boolean
C4073162 (UMLS CUI [1])
Compliance behavior | Diet therapy | Insulin regime | Blood Glucose Self-Monitoring
Item
4. have achieved compliance with their diets and insulin therapies as determined by the investigators and perform regular blood glucose monitoring.
boolean
C1321605 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0557978 (UMLS CUI [3])
C0005803 (UMLS CUI [4])
Informed Consent
Item
5. have given informed consent to participate in this study in accordance with local regulations.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Biguanides | Sulfonylurea Compounds | Glucosidase Inhibitor | Enhanced insulin sensitivity
Item
{1] have used oral antidiabetic agents, including biguanides, sulfonylureas, glucosidase inhibitors, and insulin-sensitivity enhancers within 30 days prior to entry into the study.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0005382 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C1512211 (UMLS CUI [4])
C3549878 (UMLS CUI [5])
Insulin Cumulative Dose Unit/kilogram/day
Item
[2] receive a total daily dose of insulin >2 units/kg.
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C1532634 (UMLS CUI [1,3])
Hypoglycemia Severe Episode Quantity | Hypoglycemia Disabling Requirement Assistance
Item
[3] have had more than two episodes of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entry into the study.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0020615 (UMLS CUI [2,1])
C4061999 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1269765 (UMLS CUI [2,4])
Body mass index
Item
[4] have a body mass index >35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Serum creatinine raised
Item
[5] have serum creatinine > the upper limit of normal (uln), as determined by a local laboratory.
boolean
C0700225 (UMLS CUI [1])
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