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Diabetes Mellitus, Type 2 ×
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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Eligibility Type 2 Diabetes NCT00641251

- 4/21/18 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00641251

Eligibility Type 2 Diabetes NCT00508599

- 4/21/18 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
The Effects of Two Days of Bedrest on Insulin Resistance in Type 2 Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00508599

Eligibility Diabetes Mellitus, Type 2 NCT00541697

- 4/21/18 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Eze/Simva Switch Study in Diabetics (0653A-807); ODM derived from: https://clinicaltrials.gov/show/NCT00541697

Eligibility Diabetes NCT00184613

- 8/9/16 - 1 form, 2 itemgroups, 11 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00184613

German Center for Diabetes Research (DZD) - Core Data Set - Base set

- 7/15/24 - 2 forms, 8 itemgroups, 147 items, 2 languages
Itemgroups: IG.1, IG.2, IG.3, IG.4, IG.5, IG.6, IG.7, Fragebogen
The German Center for Diabetes Research (DZD) has created a core data set for research on diabetes. It is published with permission by the DZD. The complete metadata and SOP are registered at DOI 10.5281/zenodo.7360000 For more information on the work of the DZD see: www.dzd-ev.de/en or contact: studien@dzd-ev.de German Center for Diabetes Research (DZD) Head Office at Helmholtz Zentrum München Ingolstädter Landstr. 1 85764 Neuherberg, Germany The German and English version of the Baecke Questionnaire in this core data set is based on the original paper by Baecke et al (https://doi.org/10.1093/ajcn/36.5.936), redistributed by ten Velde et al. (https://doi.org/10.1371/journal.pone.0256448), and the German translation and modification by Wagner & Singer (2003). The questionnaire was selectively modified by the German Diabetes Center (DDZ). Changes in this version 4 (15.07.2024) compared to version 3 (26.02.2024) include the addition of the parameters defined in the core data set of the German Centers for Health Research (DZG) (ID of MDM entry: 45851), the addition of laterality-specific blindness and an update of the terminology coding. The coding of the DZG parameters is currently under revision and not included in this current version. The coding of those DZG parameters that were already included in the DZD CDS will be provisionally retained.

Optional Set

3 itemgroups 46 items

Visit 9 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/19/22 - 1 form, 10 itemgroups, 45 items, 1 language
Itemgroups: Date of Visit, Physical Examination, Orthostatic vital signs, 12 Lead ECG, Weight, Waist and Hip Circumference, Pregnancy Test, EQ-5D, ADDQol, Diab-MedSat
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 9

Visit 3 (Washout) Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/19/22 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: Date of Visit, Orthostatic Vital Signs, 12 Lead ECG, Weight
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 3

Screening Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/18/22 - 1 form, 18 itemgroups, 97 items, 1 language
Itemgroups: Cover Page, Informed Consent, Inclusion Criteria, Exclusion Criteria, Demographics, Primary Diagnosis, Subject Characteristics, Date of Visit, Tobacco History, Alcohol History, Urinary Tract Infection History, Genital Infection History, Physical Examination, Orthostatic vital signs, 12 Lead ECG 1, Height and Weight, Previous Diabetes Medication Use, Pregnancy Test
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Screening

Early Discontinuation Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/18/22 - 1 form, 10 itemgroups, 45 items, 1 language
Itemgroups: Date of Visit, Physical Examination, Orthostatic vital signs, 12 Lead ECG 1, Weight, Waist and Hip Circumference, Pregnancy Test, EQ-5D, ADDQol, Diab-MedSat
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Early Discontinuation

Visit 2 (Washout) Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/18/22 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: Date of Visit, Orthostatic Vital Signs, Weight
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study Visit 2

Visit 10 Diabetes Mellitus-ASP1941-1941-CL-0004 NCT01071850

- 2/16/22 - 1 form, 4 itemgroups, 13 items, 1 language
Itemgroups: Date of Visit, Orthostatic Vital Signs, Weight, Waist and Hip Circumference
A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Subjects with Type 2 Diabetes MellitusTEST Study

Eligibility NCT01241448 Diabetes Mellitus, Type 2 - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 44 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01241448

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