NCT01906294

Brief Summary

This observation plan outlines the approach to build a diabetes registry to collect data on daily routine of treatment of Type 2 Diabetes Mellitus.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,104

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 11, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

July 15, 2013

Last Update Submit

April 8, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • routine treatment data (composite of e.g. diagnostics, kind and dosage of pharmacological diabetes treatment)

    The objective of the project is to develop a sustainable Type 2 Diabetes Mellitus (T2DM) registry to collect daily routine treatment data (e.g. diagnostics, kind and dosage of pharmacological diabetes treatment) to provide a better understanding of the disease specific epidemiology, treatment patterns, patient relevant outcomes, patient subgroups, specifically among patients with Type 2 Diabetes Mellitus. Further DDG ("Deutsche Diabetes Gesellschaft") guideline adherence and economic aspects of diabetes treatment should be evaluated on the basis of this registry data.

    From date of registration every 3 months until end of study (up to 120 months)

Study Arms (1)

Type 2 Diabetes Mellitus

Patients with antidiabetic treatment for Type 2 Diabetes Mellitus

Drug: antidiabetic treatment (ATC A10B)

Interventions

antidiabetic treatment (ATC A10B)DRUG
Type 2 Diabetes Mellitus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Type 2 Diabetes Mellitus

You may qualify if:

  • Provision of signed written informed consent
  • Age of 18 years or older
  • Diagnosis of Type 2 Diabetes Mellitus (T2DM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis Dr. med. Birgit Böttger

Frankfurt am Main, 60325, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Stephan Martin, Prof. Dr.

    Verbund der Katholischen Kliniken Düsseldorf (VKKD) Westdeutschen Diabetes- und Gesundheitszentrum (WDGZ)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 24, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 11, 2016

Record last verified: 2016-04

Locations

DE(1)