A Non-Interventional Study To Evaluate Diabetes Related Quality Of Life, Frequency And Impact Of Hypoglycemia In T2DM (INSIGHT)
5. september 2014 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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)
Studietype
Observasjonsmessig
Registrering (Faktiske)
4911
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Delhi, India
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New Delhi, India
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Andhara Pradesh
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Vijayawada, Andhara Pradesh, India
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India
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Khammam, Andhra Pradesh, India
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Kurnool, Andhra Pradesh, India
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Nellore, Andhra Pradesh, India
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Vijayawada, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Andhra Pradesh,
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Hanamkoda, Andhra Pradesh,, India
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Kammam, Andhra Pradesh,, India
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Khammam, Andhra Pradesh,, India
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Vijayawada, Andhra Pradesh,, India
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Assam
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Guwahati, Assam, India
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Bangalore
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Mysore, Bangalore, India
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Chhattisgarh
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Bilaspur, Chhattisgarh, India
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Raipur, Chhattisgarh, India
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Goa
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Mapusa, Goa, India
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Gujarat
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Ahemdabad, Gujarat, India
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Ahmadabad, Gujarat, India
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Anand, Gujarat, India
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Chennai, Gujarat, India
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Nadiad, Gujarat, India
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Vadodara, Gujarat, India
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Haryana
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Karnal, Haryana, India
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Haryana-
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Panchkula, Haryana-, India
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Jharkhand
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Dhanbad, Jharkhand, India
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Ranchi, Jharkhand, India
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Karnataka
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Bangalore, Karnataka, India
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Kanpur, Karnataka, India
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Mangalore, Karnataka, India
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Mysore, Karnataka, India
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Trichy, Karnataka, India
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Karnatka
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Hubli, Karnatka, India
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Mangalore, Karnatka, India
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Mysore, Karnatka, India
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Kerala
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Kannur, Kerala, India
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MP
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Indore, MP, India
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Madhya Pradesh
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Bhopal, Madhya Pradesh, India
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Gwalior, Madhya Pradesh, India
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Indore(MP), Madhya Pradesh, India
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Ujain, Madhya Pradesh, India
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Maharastra
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Mumbai, Maharastra, India
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Pune, Maharastra, India
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Mahrastra
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Pune, Mahrastra, India
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New Delhi
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Delhi, New Delhi, India
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New Delh, New Delhi, India
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Orissa
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Bhubaneswar, Orissa, India
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Pondicherry
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Puducherry, Pondicherry, India
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Punjab
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Ludhiana, Punjab, India
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Rajasthan
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Jaipur, Rajasthan, India
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Jodhpur, Rajasthan, India
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Kota, Rajasthan, India
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Pushkar, Rajasthan, India
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Tamil Nadu
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Chennai, Tamil Nadu, India
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Chennai., Tamil Nadu, India
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Madurai, Tamil Nadu, India
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Tamilnadu
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Chennai, Tamilnadu, India
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Coimbatore, Tamilnadu, India
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Cuddlore, Tamilnadu, India
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Kanchipuram, Tamilnadu, India
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Karaikal, Tamilnadu, India
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Thuckalay, Tamilnadu, India
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Trichy, Tamilnadu, India
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Vellore, Tamilnadu, India
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UP
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Bhilai, UP, India
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Fatepur, UP, India
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Ghaziabad, UP, India
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Kanpur, UP, India
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Noida, UP, India
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Uttar Pradesh
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Gorakhpur, Uttar Pradesh, India
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Lucknow, Uttar Pradesh, India
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Noida, Uttar Pradesh, India
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West Bangal
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Kolkata, West Bangal, India
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West Bengal
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Kolkata, West Bengal, India
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
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1
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Diabetic Quality of Life using Modified 15 item DQoL (MDQoL) questionnaire
Tidsramme: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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HbA1c and its correlation with frequency of hypoglycemia
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 2nd February 2012 - 2nd August 2012
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2nd February 2012 - 2nd August 2012
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Abhay Raut, MD, Prashanti Clinic,
- Hovedetterforsker: Sashi Kumar, MBBS, Dianova Diabetes Centre
- Hovedetterforsker: Subodh Chandra, MD, Chandra Medicals Pvt. Ltd
- Hovedetterforsker: Debashish Maji, MD, DM, Calcutta Diabetes and endocrine Foundation,
- Hovedetterforsker: Mayur Patel, MD, Swasthya (All India Institute of Diabetes and Research)
- Hovedetterforsker: Nallaperumal Sivagnam, MBBS, Swamy Diabetes Centre,
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2012
Primær fullføring (Faktiske)
1. februar 2013
Studiet fullført (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først innsendt
30. januar 2012
Først innsendt som oppfylte QC-kriteriene
30. januar 2012
Først lagt ut (Anslag)
1. februar 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. september 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. september 2014
Sist bekreftet
1. september 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NIS-CIN-XXX-2011/3
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .