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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02355145
Date of registration:	16/01/2015
Prospective Registration:	Yes
Primary sponsor:	AstraZeneca
Public title:	Non-inteRvEntional Study to Observe rAtionaLe to Select add-on TherapY for Type 2 Diabetes Inadequately Controlled With Metformin. REALITY
Scientific title:	REALITY: A Non-inteRvEntional Study to Observe the rAtionaLe of selectIng add-on TherapY for Type 2 Diabetes Inadequately Controlled With Metformin in Real-life Practice at 1 Year Distance
Date of first enrolment:	April 2, 2015
Target sample size:	1005
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02355145
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Bulgaria

Contacts

Name:	Marina Staneva
Address:
Telephone:
Email:
Affiliation:	AstraZeneca Bulgaria

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Primary Outcome(s)

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 [Time Frame: From moment 1 (up to 2 months from FSI) to moment 2 (1 year after moment 1)]

Secondary Outcome(s)

Number of years (duration) of add-on therapies in type 2 diabetes [Time Frame: 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 until starting the add-on therapies after diagnosis [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)]

Secondary ID(s)

D1843R00243

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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