Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

5. september 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

4911

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Indien
      • Delhi, Indien
        • Research Site
      • New Delhi, Indien
        • Research Site
    • Andhara Pradesh
      • Vijayawada, Andhara Pradesh, Indien
        • Research Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indien
        • Research Site
      • Khammam, Andhra Pradesh, Indien
        • Research Site
      • Kurnool, Andhra Pradesh, Indien
        • Research Site
      • Nellore, Andhra Pradesh, Indien
        • Research Site
      • Vijayawada, Andhra Pradesh, Indien
        • Research Site
      • Visakhapatnam, Andhra Pradesh, Indien
        • Research Site
    • Andhra Pradesh,
      • Hanamkoda, Andhra Pradesh,, Indien
        • Research Site
      • Kammam, Andhra Pradesh,, Indien
        • Research Site
      • Khammam, Andhra Pradesh,, Indien
        • Research Site
      • Vijayawada, Andhra Pradesh,, Indien
        • Research Site
    • Assam
      • Guwahati, Assam, Indien
        • Research Site
    • Bangalore
      • Mysore, Bangalore, Indien
        • Research Site
    • Chhattisgarh
      • Bilaspur, Chhattisgarh, Indien
        • Research Site
      • Raipur, Chhattisgarh, Indien
        • Research Site
    • Goa
      • Mapusa, Goa, Indien
        • Research Site
    • Gujarat
      • Ahemdabad, Gujarat, Indien
        • Research Site
      • Ahmadabad, Gujarat, Indien
        • Research Site
      • Anand, Gujarat, Indien
        • Research Site
      • Chennai, Gujarat, Indien
        • Research Site
      • Nadiad, Gujarat, Indien
        • Research Site
      • Vadodara, Gujarat, Indien
        • Research Site
    • Haryana
      • Karnal, Haryana, Indien
        • Research Site
    • Haryana-
      • Panchkula, Haryana-, Indien
        • Research Site
    • Jharkhand
      • Dhanbad, Jharkhand, Indien
        • Research Site
      • Ranchi, Jharkhand, Indien
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, Indien
        • Research Site
      • Kanpur, Karnataka, Indien
        • Research Site
      • Mangalore, Karnataka, Indien
        • Research Site
      • Mysore, Karnataka, Indien
        • Research Site
      • Trichy, Karnataka, Indien
        • Research Site
    • Karnatka
      • Hubli, Karnatka, Indien
        • Research Site
      • Mangalore, Karnatka, Indien
        • Research Site
      • Mysore, Karnatka, Indien
        • Research Site
    • Kerala
      • Kannur, Kerala, Indien
        • Research Site
    • MP
      • Indore, MP, Indien
        • Research Site
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, Indien
        • Research Site
      • Gwalior, Madhya Pradesh, Indien
        • Research Site
      • Indore(MP), Madhya Pradesh, Indien
        • Research Site
      • Ujain, Madhya Pradesh, Indien
        • Research Site
    • Maharastra
      • Mumbai, Maharastra, Indien
        • Research Site
      • Pune, Maharastra, Indien
        • Research Site
    • Mahrastra
      • Pune, Mahrastra, Indien
        • Research Site
    • New Delhi
      • Delhi, New Delhi, Indien
        • Research Site
      • New Delh, New Delhi, Indien
        • Research Site
    • Orissa
      • Bhubaneswar, Orissa, Indien
        • Research Site
    • Pondicherry
      • Puducherry, Pondicherry, Indien
        • Research Site
    • Punjab
      • Ludhiana, Punjab, Indien
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, Indien
        • Research Site
      • Jodhpur, Rajasthan, Indien
        • Research Site
      • Kota, Rajasthan, Indien
        • Research Site
      • Pushkar, Rajasthan, Indien
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, Indien
        • Research Site
      • Chennai., Tamil Nadu, Indien
        • Research Site
      • Madurai, Tamil Nadu, Indien
        • Research Site
    • Tamilnadu
      • Chennai, Tamilnadu, Indien
        • Research Site
      • Coimbatore, Tamilnadu, Indien
        • Research Site
      • Cuddlore, Tamilnadu, Indien
        • Research Site
      • Kanchipuram, Tamilnadu, Indien
        • Research Site
      • Karaikal, Tamilnadu, Indien
        • Research Site
      • Thuckalay, Tamilnadu, Indien
        • Research Site
      • Trichy, Tamilnadu, Indien
        • Research Site
      • Vellore, Tamilnadu, Indien
        • Research Site
    • UP
      • Bhilai, UP, Indien
        • Research Site
      • Fatepur, UP, Indien
        • Research Site
      • Ghaziabad, UP, Indien
        • Research Site
      • Kanpur, UP, Indien
        • Research Site
      • Noida, UP, Indien
        • Research Site
    • Uttar Pradesh
      • Gorakhpur, Uttar Pradesh, Indien
        • Research Site
      • Lucknow, Uttar Pradesh, Indien
        • Research Site
      • Noida, Uttar Pradesh, Indien
        • Research Site
    • West Bangal
      • Kolkata, West Bangal, Indien
        • Research Site
    • West Bengal
      • Kolkata, West Bengal, Indien
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Tværsnit

Kohorter og interventioner

Gruppe / kohorte
1

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
Tidsramme: 2nd February 2012 - 2nd August 2012
2nd February 2012 - 2nd August 2012

Sekundære resultatmål

Resultatmål
Tidsramme
HbA1c and its correlation with frequency of hypoglycemia
Tidsramme: 2nd February 2012 - 2nd August 2012
2nd February 2012 - 2nd August 2012
Frequency and impact of hypoglycemia using HFS-II (worry subscale)
Tidsramme: 2nd February 2012 - 2nd August 2012
2nd February 2012 - 2nd August 2012
Disease modifying variables Body Mass Index (BMI) and Blood Pressure (BP)
Tidsramme: 2nd February 2012 - 2nd August 2012
2nd February 2012 - 2nd August 2012

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Efterforskere

  • Ledende efterforsker: Abhay Raut, MD, Prashanti Clinic,
  • Ledende efterforsker: Sashi Kumar, MBBS, Dianova Diabetes Centre
  • Ledende efterforsker: Subodh Chandra, MD, Chandra Medicals Pvt. Ltd
  • Ledende efterforsker: Debashish Maji, MD, DM, Calcutta Diabetes and endocrine Foundation,
  • Ledende efterforsker: Mayur Patel, MD, Swasthya (All India Institute of Diabetes and Research)
  • Ledende efterforsker: Nallaperumal Sivagnam, MBBS, Swamy Diabetes Centre,

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2012

Primær færdiggørelse (Faktiske)

1. februar 2013

Studieafslutning (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først indsendt

30. januar 2012

Først indsendt, der opfyldte QC-kriterier

30. januar 2012

Først opslået (Skøn)

1. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. september 2014

Sidst verificeret

1. september 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NIS-CIN-XXX-2011/3

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type II diabetes mellitus

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Brazil

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner