Status:
COMPLETED
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM
Lead Sponsor:
AstraZeneca
Conditions:
Type II Diabetes Mellitus
Eligibility:
All Genders
18+ years
Brief Summary
This is a non-interventional, cross sectional, multicentric study in T2DM patients which will involve a single visit for study related procedures. This study will be conducted in approximately 5,000 p...
Detailed Description
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
Eligibility Criteria
Inclusion
- Patients with diagnosis of T2DM for \> 1 year prior to entry in the study willing and able to complete the questionnaire and on pharmacotherapy
- Patients who are currently treated with a single or combination of injectable/oral antidiabetic drugs with or without insulin therapy
- Treatment type must be unchanged in the previous 3 months. However, dose modifications are allowed
- Patients who agree to participate in the study and give their written informed consent
Exclusion
- Patients with type 1 diabetes
- Patients with diabetic ketoacidosis and/or hyperosmolar hyperglycaemic state
- Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies)
- Patients with concurrent treatment involving systemic glucocorticoids. However, inhaled, locally injected and topical use of glucocorticoids is allowed
- Patients suffering from severe cardiac, hepatic, renal diseases as judged by the investigator
- Any condition of the patient which may have an impact on objective and outcome of the trial example: patients currently undergoing major/ minor surgical
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
4911 Patients enrolled
Trial Details
Trial ID
NCT01523405
Start Date
March 1 2012
End Date
February 1 2013
Last Update
September 8 2014
Active Locations (70)
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1
Research Site
Vijayawada, Andhara Pradesh, India
2
Research Site
Hanamkoda, Andhra Pradesh, India
3
Research Site
Hyderabad, Andhra Pradesh, India
4
Research Site
Kammam, Andhra Pradesh, India