NCT02355145

Brief Summary

A non-interventional, multicentre study to observe the main criteria used in clinical practice by physicians when selecting the second-line add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Data will be collected by reviewing the medical records of patients with type 2 diabetes and add-on therapies at the time of presenting to endocrinologist according to clinical practice. The patients will participate in only one study visit, at the time of enrolment. Two study groups are to be defined at two time-points.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,005

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 2, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2016

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

January 16, 2015

Last Update Submit

May 24, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes, add-on diabetes therapy, rationale

Outcome Measures

Primary Outcomes (1)

  • Change in the frequency of usage by physicians of the main criteria for selecting the add-on therapy in patients with inadequately metformin-controlled type 2 diabetes

    To describe and compare the main criteria used by physicians (regular outpatient setting) in selecting the add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Descriptive analysis will be produced for the response to questions stratified by patients (binominal variable) and within physician clusters (derived percentages). To describe the overall changes descriptive analysis will be used for those physician who have responses both in 2 time points at 1 year distance.

    From moment 1 (up to 2 months from FSI) to moment 2 (1 year after moment 1)

Secondary Outcomes (6)

  • Number of years (duration) of add-on therapies in type 2 diabetes

    in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)

  • Percentage of subjects with specific comorbid conditions and/or diabetes complications

    in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)

  • Percentage of patients with target HbA1c level < 7% at the 2 time-points

    in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)

  • Number of years of type 2 diabetes disease duration

    in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)

  • Frequency of the used classes of drugs

    in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)

  • +1 more secondary outcomes

Study Arms (2)

Patient group in moment 1 of evaluation

Study group enrolled in moment 1 of evaluation (Feb - Mar 2015)

Patient group in moment 2 of evaluation

Study group enrolled in moment 2 of evaluation (Feb - Mar 2016) - 1 year distance from moment 1

Eligibility Criteria

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

Type 2 diabetes patients, inadequately controlled with metformin, with a current treatment based on any add-on (non-insulin) diabetes therapy.

You may qualify if:

  • Provision of subject informed consent
  • Female and/or male aged 18 years and over
  • Diagnosis of type 2 diabetes mellitus
  • Patients considered inadequately controlled with metformin with a current treatment based on any add-on diabetes therapy

You may not qualify if:

  • Diagnosis of type 1 diabetes
  • Current antidiabetes treatment with oral monotherapy
  • Insulin treatment for type 2 diabetes
  • Current participation in any clinical trial
  • Patient who have been enrolled in the study at point 1 can not be enrolled at point 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Pleven, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Stara Zagora, Bulgaria

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Marina Staneva

    AstraZeneca Bulgaria

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

February 4, 2015

Study Start

April 2, 2015

Primary Completion

July 28, 2016

Study Completion

July 28, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

BU(3)