ID

25670

Description

Naturlose (D-Tagatose) Efficacy Evaluation Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00955747

Link

https://clinicaltrials.gov/show/NCT00955747

Keywords

Versions (1)
  1. 9/9/17 9/9/17 -
Uploaded on

September 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00955747

English

Eligibility Type 2 Diabetes NCT00955747

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetics in accordance with who.
Description

Non-Insulin-Dependent Diabetes Mellitus WHO classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C4267671
male and female patients, between 18 and 75 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diabetic patients who are not on medication for the disease. patients may be treated with diet and exercise.
Description

Patient Diabetic | Pharmaceutical Preparations Absent | Diet therapy | Exercise regime

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0241863
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0454291
normal blood creatine clearance and normal liver function test results.
Description

Creatinine clearance Normal | Liver function tests normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0812399
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0438235
bmi less than or equal to 45kg/m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with sulfonylurea (e.g., glyburide, glipizide, glimepiride, chlorpropamide, tolazamide, acetohexamide, or tolbutamide), tzds, metformin, acarbose, byetta, insulin, and any antidiabetic medications within the prior 3 months.
Description

Sulfonylurea | Glyburide | Glipizide | glimepiride | Chlorpropamide | Tolazamide | Acetohexamide | Tolbutamide | Thiazolidinediones | Metformin | Acarbose | Byetta | Insulin | Antidiabetics

Data type

boolean

Alias
UMLS CUI [1]
C0038766
UMLS CUI [2]
C0017628
UMLS CUI [3]
C0017642
UMLS CUI [4]
C0061323
UMLS CUI [5]
C0008287
UMLS CUI [6]
C0040372
UMLS CUI [7]
C0000992
UMLS CUI [8]
C0040374
UMLS CUI [9]
C1257987
UMLS CUI [10]
C0025598
UMLS CUI [11]
C0050393
UMLS CUI [12]
C1636686
UMLS CUI [13]
C0021641
UMLS CUI [14]
C0935929
therapy with beta-blockers or thiazide diuretics within the prior 3 months.
Description

Adrenergic beta-Antagonists | Thiazide Diuretics

Data type

boolean

Alias
UMLS CUI [1]
C0001645
UMLS CUI [2]
C0012802
pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using inadequate contraceptive measure.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Inadequate

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0205412
documented gastrointestinal disease, or taking of medications likely to alter gut motility or absorption.
Description

Gastrointestinal Diseases | Pharmaceutical Preparations Changing Intestinal Motility | Pharmaceutical Preparations Changing Intestinal Absorption

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0021838
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0021826
receiving any investigational drug within 30 days of the baseline visit.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Type 2 Diabetes NCT00955747

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus WHO classification
Item
type 2 diabetics in accordance with who.
boolean
C0011860 (UMLS CUI [1,1])
C4267671 (UMLS CUI [1,2])
Age
Item
male and female patients, between 18 and 75 years of age.
boolean
C0001779 (UMLS CUI [1])
Patient Diabetic | Pharmaceutical Preparations Absent | Diet therapy | Exercise regime
Item
diabetic patients who are not on medication for the disease. patients may be treated with diet and exercise.
boolean
C0030705 (UMLS CUI [1,1])
C0241863 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0012159 (UMLS CUI [3])
C0454291 (UMLS CUI [4])
Creatinine clearance Normal | Liver function tests normal
Item
normal blood creatine clearance and normal liver function test results.
boolean
C0812399 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0438235 (UMLS CUI [2])
Body mass index
Item
bmi less than or equal to 45kg/m2.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Sulfonylurea | Glyburide | Glipizide | glimepiride | Chlorpropamide | Tolazamide | Acetohexamide | Tolbutamide | Thiazolidinediones | Metformin | Acarbose | Byetta | Insulin | Antidiabetics
Item
treatment with sulfonylurea (e.g., glyburide, glipizide, glimepiride, chlorpropamide, tolazamide, acetohexamide, or tolbutamide), tzds, metformin, acarbose, byetta, insulin, and any antidiabetic medications within the prior 3 months.
boolean
C0038766 (UMLS CUI [1])
C0017628 (UMLS CUI [2])
C0017642 (UMLS CUI [3])
C0061323 (UMLS CUI [4])
C0008287 (UMLS CUI [5])
C0040372 (UMLS CUI [6])
C0000992 (UMLS CUI [7])
C0040374 (UMLS CUI [8])
C1257987 (UMLS CUI [9])
C0025598 (UMLS CUI [10])
C0050393 (UMLS CUI [11])
C1636686 (UMLS CUI [12])
C0021641 (UMLS CUI [13])
C0935929 (UMLS CUI [14])
Adrenergic beta-Antagonists | Thiazide Diuretics
Item
therapy with beta-blockers or thiazide diuretics within the prior 3 months.
boolean
C0001645 (UMLS CUI [1])
C0012802 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Inadequate
Item
pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using inadequate contraceptive measure.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
Gastrointestinal Diseases | Pharmaceutical Preparations Changing Intestinal Motility | Pharmaceutical Preparations Changing Intestinal Absorption
Item
documented gastrointestinal disease, or taking of medications likely to alter gut motility or absorption.
boolean
C0017178 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0021838 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0021826 (UMLS CUI [3,3])
Investigational New Drugs
Item
receiving any investigational drug within 30 days of the baseline visit.
boolean
C0013230 (UMLS CUI [1])
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