A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM (INSIGHT)

AstraZeneca

Status: Completed

Conditions: Type II Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT01523405

NIS-CIN-XXX-2011/3

Details and patient eligibility

About

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 patients at around 300 hospitals/primary care clinics across India. Approximately 18-20 patients per site will be enrolled. This study has been designed to evaluate diabetes related quality of life (DQoL), frequency and impact of hypoglycaemia in relation to HbA1c control and to assess disease modifying variables-BMI and BP in T2DM patients on oral / injectable anti-diabetic drugs with/without insulin therapy.

Full 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)

Enrollment: 4,911 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

4,911 participants in 1 patient group

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