ID

33121

Description

Comparison of the Efficacy and Safety Between Pioglitazone and Placebo Added to Combination Therapy in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00991055

Link

https://clinicaltrials.gov/show/NCT00991055

Keywords

Versions (1)
  1. 11/28/18 11/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00991055

English

Eligibility Type 2 Diabetes NCT00991055

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female, aged > 25 years and had been diagnosed as type 2 diabetes for at least 3 months before study entry.
Description

Age | Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
2. subjects have taken sulfonylurea plus metformin therapy for at least 3 months before study entry.
Description

Sulfonylurea | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0038766
UMLS CUI [2]
C0025598
3. subjects have to take daily metformin 500~2000mg tolerable dosages and sulfonylurea (such as the usage dose of glimepiride ≧4mg; dose of gliclazide≧160mg; dose of glipizide ≧20mg; dose of glyburide≧4mg) for at least 1 months.
Description

Metformin Dose U/day | Sulfonylurea | Glimepiride Dose | Gliclazide Dose | Glipizide Dose | Glyburide Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
UMLS CUI [2]
C0038766
UMLS CUI [3,1]
C0061323
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0017631
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C0017642
UMLS CUI [5,2]
C0178602
UMLS CUI [6,1]
C0017628
UMLS CUI [6,2]
C0178602
4. those subjects with hba1c historical levels between 7.0% and 11.0% within 3 month prior to study entry.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
5. bmi between 20-35 kg /m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
6. each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document.
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
7. subjects have been under stable diet control for at least 1 month before study entry.
Description

Dietary control Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0743195
UMLS CUI [1,2]
C0205360
8. subjects are willing to stick to current diet and sulfonylurea plus metformin treatment plan during this trial.
Description

Treatment Adherence | Diet | Sulfonylurea | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C4505265
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0038766
UMLS CUI [4]
C0025598
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant women or lactating mothers.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. type 1 dm(iddm), or diabetes caused by pancreas damage、secondary forms of diabetes, i.e., cushing's syndrome or acromegaly.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus caused by Pancreas damage | Secondary diabetes mellitus | Cushing Syndrome | Acromegaly

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0030274
UMLS CUI [2,4]
C0010957
UMLS CUI [3]
C0271640
UMLS CUI [4]
C0010481
UMLS CUI [5]
C0001206
3. a history of acute metabolic complication within 3 months before study entry, i.e., ketoacidosis or hyperosmolar state (coma).
Description

Complication Metabolic | Ketoacidosis | Hyperosmolar state | Coma

Data type

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0311400
UMLS CUI [2]
C0220982
UMLS CUI [3]
C0236013
UMLS CUI [4]
C0009421
4. there are significant macrovascular complications (i.e. unstable angina or acute myocardial infarction) or renal impairment (serum creatinine higher than 1.5 mg/dl).
Description

Complication Macrovascular | Angina, Unstable | Myocardial Infarction | Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C2609253
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4]
C1565489
UMLS CUI [5]
C0201976
5. have a known allergy to pioglitazone.
Description

Hypersensitivity Pioglitazone

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0071097
6. other medications can be taken if their use had been instituted before study entry, but agents that can interfere with study evaluations, including other oral antidiabetic agents and corticosteroids, were not allowed.
Description

Pharmaceutical Preparations Interfere with Evaluation | Antidiabetics Oral | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1261322
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0001617
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Similar models

Eligibility Type 2 Diabetes NCT00991055

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
1. male or female, aged > 25 years and had been diagnosed as type 2 diabetes for at least 3 months before study entry.
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Sulfonylurea | Metformin
Item
2. subjects have taken sulfonylurea plus metformin therapy for at least 3 months before study entry.
boolean
C0038766 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Metformin Dose U/day | Sulfonylurea | Glimepiride Dose | Gliclazide Dose | Glipizide Dose | Glyburide Dose
Item
3. subjects have to take daily metformin 500~2000mg tolerable dosages and sulfonylurea (such as the usage dose of glimepiride ≧4mg; dose of gliclazide≧160mg; dose of glipizide ≧20mg; dose of glyburide≧4mg) for at least 1 months.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2])
C0061323 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0017631 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0017642 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0017628 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
Hemoglobin A1c measurement
Item
4. those subjects with hba1c historical levels between 7.0% and 11.0% within 3 month prior to study entry.
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
5. bmi between 20-35 kg /m2.
boolean
C1305855 (UMLS CUI [1])
Protocol Compliance | Informed Consent
Item
6. each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Dietary control Stable
Item
7. subjects have been under stable diet control for at least 1 month before study entry.
boolean
C0743195 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Treatment Adherence | Diet | Sulfonylurea | Metformin
Item
8. subjects are willing to stick to current diet and sulfonylurea plus metformin treatment plan during this trial.
boolean
C4505265 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant women or lactating mothers.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus caused by Pancreas damage | Secondary diabetes mellitus | Cushing Syndrome | Acromegaly
Item
2. type 1 dm(iddm), or diabetes caused by pancreas damage、secondary forms of diabetes, i.e., cushing's syndrome or acromegaly.
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0030274 (UMLS CUI [2,3])
C0010957 (UMLS CUI [2,4])
C0271640 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
C0001206 (UMLS CUI [5])
Complication Metabolic | Ketoacidosis | Hyperosmolar state | Coma
Item
3. a history of acute metabolic complication within 3 months before study entry, i.e., ketoacidosis or hyperosmolar state (coma).
boolean
C0009566 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0220982 (UMLS CUI [2])
C0236013 (UMLS CUI [3])
C0009421 (UMLS CUI [4])
Complication Macrovascular | Angina, Unstable | Myocardial Infarction | Renal Insufficiency | Creatinine measurement, serum
Item
4. there are significant macrovascular complications (i.e. unstable angina or acute myocardial infarction) or renal impairment (serum creatinine higher than 1.5 mg/dl).
boolean
C0009566 (UMLS CUI [1,1])
C2609253 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Hypersensitivity Pioglitazone
Item
5. have a known allergy to pioglitazone.
boolean
C0020517 (UMLS CUI [1,1])
C0071097 (UMLS CUI [1,2])
Pharmaceutical Preparations Interfere with Evaluation | Antidiabetics Oral | Adrenal Cortex Hormones
Item
6. other medications can be taken if their use had been instituted before study entry, but agents that can interfere with study evaluations, including other oral antidiabetic agents and corticosteroids, were not allowed.
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
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