A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM (INSIGHT)
5 september 2014 uppdaterad av: AstraZeneca
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In Type 2 Diabetes Patients On Pharmacotherapy (INSIGHT)
Studietyp
Observationell
Inskrivning (Faktisk)
4911
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Delhi, Indien
- Research Site
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New Delhi, Indien
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Andhara Pradesh
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Vijayawada, Andhara Pradesh, Indien
- Research Site
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Indien
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Khammam, Andhra Pradesh, Indien
- Research Site
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Kurnool, Andhra Pradesh, Indien
- Research Site
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Nellore, Andhra Pradesh, Indien
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Vijayawada, Andhra Pradesh, Indien
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Visakhapatnam, Andhra Pradesh, Indien
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Andhra Pradesh,
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Hanamkoda, Andhra Pradesh,, Indien
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Kammam, Andhra Pradesh,, Indien
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Khammam, Andhra Pradesh,, Indien
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Vijayawada, Andhra Pradesh,, Indien
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Assam
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Guwahati, Assam, Indien
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Bangalore
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Mysore, Bangalore, Indien
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Chhattisgarh
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Bilaspur, Chhattisgarh, Indien
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Raipur, Chhattisgarh, Indien
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Goa
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Mapusa, Goa, Indien
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Gujarat
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Ahemdabad, Gujarat, Indien
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Ahmadabad, Gujarat, Indien
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Anand, Gujarat, Indien
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Chennai, Gujarat, Indien
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Nadiad, Gujarat, Indien
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Vadodara, Gujarat, Indien
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Haryana
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Karnal, Haryana, Indien
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Haryana-
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Panchkula, Haryana-, Indien
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Jharkhand
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Dhanbad, Jharkhand, Indien
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Ranchi, Jharkhand, Indien
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Karnataka
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Bangalore, Karnataka, Indien
- Research Site
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Kanpur, Karnataka, Indien
- Research Site
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Mangalore, Karnataka, Indien
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Mysore, Karnataka, Indien
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Trichy, Karnataka, Indien
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Karnatka
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Hubli, Karnatka, Indien
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Mangalore, Karnatka, Indien
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Mysore, Karnatka, Indien
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Kerala
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Kannur, Kerala, Indien
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MP
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Indore, MP, Indien
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Madhya Pradesh
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Bhopal, Madhya Pradesh, Indien
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Gwalior, Madhya Pradesh, Indien
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Indore(MP), Madhya Pradesh, Indien
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Ujain, Madhya Pradesh, Indien
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Maharastra
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Mumbai, Maharastra, Indien
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Pune, Maharastra, Indien
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Mahrastra
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Pune, Mahrastra, Indien
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New Delhi
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Delhi, New Delhi, Indien
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New Delh, New Delhi, Indien
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Orissa
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Bhubaneswar, Orissa, Indien
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Pondicherry
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Puducherry, Pondicherry, Indien
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Punjab
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Ludhiana, Punjab, Indien
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Rajasthan
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Jaipur, Rajasthan, Indien
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Jodhpur, Rajasthan, Indien
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Kota, Rajasthan, Indien
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Pushkar, Rajasthan, Indien
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Tamil Nadu
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Chennai, Tamil Nadu, Indien
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Chennai., Tamil Nadu, Indien
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Madurai, Tamil Nadu, Indien
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Tamilnadu
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Chennai, Tamilnadu, Indien
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Coimbatore, Tamilnadu, Indien
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Cuddlore, Tamilnadu, Indien
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Kanchipuram, Tamilnadu, Indien
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Karaikal, Tamilnadu, Indien
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Thuckalay, Tamilnadu, Indien
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Trichy, Tamilnadu, Indien
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Vellore, Tamilnadu, Indien
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UP
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Bhilai, UP, Indien
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Fatepur, UP, Indien
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Ghaziabad, UP, Indien
- Research Site
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Kanpur, UP, Indien
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Noida, UP, Indien
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Uttar Pradesh
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Gorakhpur, Uttar Pradesh, Indien
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Lucknow, Uttar Pradesh, Indien
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Noida, Uttar Pradesh, Indien
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West Bangal
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Kolkata, West Bangal, Indien
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West Bengal
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Kolkata, West Bengal, Indien
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Approximately 5,000 adult patients (≥ 18 years) diagnosed with T2DM will be randomly selected from around 300 hospitals/primary care clinics across India to participate in this study.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Tvärsnitt
Kohorter och interventioner
Grupp / Kohort |
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1
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
Tidsram: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Sekundära resultatmått
Resultatmått |
Tidsram |
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HbA1c and its correlation with frequency of hypoglycemia
Tidsram: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Frequency and impact of hypoglycemia using HFS-II (worry subscale)
Tidsram: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)
Tidsram: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Abhay Raut, MD, Prashanti Clinic,
- Huvudutredare: Sashi Kumar, MBBS, Dianova Diabetes Centre
- Huvudutredare: Subodh Chandra, MD, Chandra Medicals Pvt. Ltd
- Huvudutredare: Debashish Maji, MD, DM, Calcutta Diabetes and endocrine Foundation,
- Huvudutredare: Mayur Patel, MD, Swasthya (All India Institute of Diabetes and Research)
- Huvudutredare: Nallaperumal Sivagnam, MBBS, Swamy Diabetes Centre,
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2012
Primärt slutförande (Faktisk)
1 februari 2013
Avslutad studie (Faktisk)
1 februari 2013
Studieregistreringsdatum
Först inskickad
30 januari 2012
Först inskickad som uppfyllde QC-kriterierna
30 januari 2012
Första postat (Uppskatta)
1 februari 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
8 september 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 september 2014
Senast verifierad
1 september 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NIS-CIN-XXX-2011/3
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .