IMS® DIAREG Diabetes Registry - Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01906294
• Other study ID #: 5050000
• Status: Terminated
• Phase: N/A
• First received: July 15, 2013
• Last updated: April 8, 2016
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: IMS HEALTH GmbH & Co. OHG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The choice to establish such a (general and specific) disease patient registry was based on several scientific and practical considerations as described in the AHRQ user's guide: registries for evaluating patient outcomes (www.ahrq.gov, 2007). From a public health point of view, such a register should monitor naturalistic (i.e., unbiased) use of diabetes treatment in the community and should primarily guide and assist medical professionals to make optimal choices in combating diabetes. The primary focus of this registry is therefore to monitor the medical and lifestyle treatment of diabetes in order to enable comparison of different treatment options and to provide data for future discussions of optimal treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2104
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of signed written informed consent

• Age of 18 years or older

• Diagnosis of Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria:

Only patients who don't fulfill the inclusion criteria will be excluded. There will be no further possibility for the treating physician to exclude individual patients.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• antidiabetic treatment (ATC A10B)

Locations

Country	Name	City	State
Germany	Praxis Dr. med. Birgit Böttger	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
IMS HEALTH GmbH & Co. OHG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No