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NCT Number: NCT01523405

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

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.

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Vijayawada, Andhara Pradesh, India

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About this study

A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire

    Time frame: 2nd February 2012 - 2nd August 2012

Secondary outcomes

  1. HbA1c and its correlation with frequency of hypoglycemia

    Time frame: 2nd February 2012 - 2nd August 2012

  2. Frequency and impact of hypoglycemia using HFS-II (worry subscale)

    Time frame: 2nd February 2012 - 2nd August 2012

  3. Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)

    Time frame: 2nd February 2012 - 2nd August 2012

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)

Acronym: INSIGHT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2012
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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