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Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Mellitus Patients (ONTARGET-INDIA)

18. december 2017 opdateret af: AstraZeneca

A Non-Interventional, Multicentre, Prospective, Observational Study to Understand Usage and Effect of Saxagliptin as First Add-On After Metformin in Indian Type 2 Diabetes Patients. (ONTARGET-India)

This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently prescribed saxagliptin as an add-on to metformin.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a multicentre, non-interventional, prospective, observational study which would be conducted in India to understand the usage and effect of saxagliptin as first add-on therapy after metformin. The study will enroll Type 2 Diabetes Mellitus (T2DM) patients who were inadequately controlled with metformin alone and have been recently (i.e. within past 15 days) prescribed saxagliptin as an add-on to metformin.

The Investigator/designee would get signed informed consent from potential subjects of the study. The patients who meet all inclusion and none of the exclusion criteria will be enrolled in the study. These patients will then be assigned a patient identification number for the study. The Investigator/designee will collect the information as per the study schedule. This will be considered as Visit 1 of the patients. The patients will be managed as per the routine clinical practice of the physician for their condition and this study will neither interfere/advise the Investigators/designee for any drug/medication to be prescribed to the patients nor prescribe any intervention to them.The enrolled patients would then be asked to visit their respective study sites after 3 months ( +7 days) for the Visit-2 of study.

Around 50 study centers throughout India will be selected with a goal of enrolling up to 1500 patients (approximately 30 subjects each per site). The study will be initiated after obtaining written approval of Independent/Institutional Ethics Committee and written Informed consent of the patient.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1200

Kontakter og lokationer

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

Studiesteder

  • Indien
      • new Delhi, Indien
        • Research Site
    • Andhra Pradesh
      • Nellure, Andhra Pradesh, Indien
        • Research Site
      • Vishakhapatnam, Andhra Pradesh, Indien
        • Research Site
    • Assam
      • Guwahati, Assam, Indien
        • Research Site
    • Delhi
      • New Delhi, Delhi, Indien
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, Indien
        • Research Site
      • Rajkot, Gujarat, Indien
        • Research Site
      • Vadodara, Gujarat, Indien
        • Research Site
    • Haryana
      • Karnal, Haryana, Indien
        • Research Site
      • Yamunanagar, Haryana, Indien
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, Indien
        • Research Site
    • Kerala
      • Trivandrum, Kerala, Indien
        • Research Site
    • Kochi
      • Cochin, Kochi, Indien
        • Research Site
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, Indien
        • Research Site
      • Indore, Madhya Pradesh, Indien
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, Indien
        • Research Site
      • Pune, Maharashtra, Indien
        • Research Site
    • Punjab
      • Amritsar, Punjab, Indien
        • Research Site
      • Chandigarh, Punjab, Indien
        • Research Site
      • Ludhiana, Punjab, Indien
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, Indien
        • Research Site
      • Udaipur, Rajasthan, Indien
        • Research Site
    • Tamiladu
      • Madurai, Tamiladu, Indien
        • Research Site
    • Tamilnadu
      • Chennai, Tamilnadu, Indien
        • Research Site
    • Telangana
      • Hyderabad, Telangana, Indien
        • Research Site
      • Hyderebad, Telangana, Indien
        • Research Site
    • Uttar Pradesh
      • Allahabad, Uttar Pradesh, Indien
        • Research Site
      • Kanpur, Uttar Pradesh, Indien
        • Research Site
      • Lucknow, Uttar Pradesh, Indien
        • Research Site
      • Noida, Uttar Pradesh, 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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Type 2 diabetes patients

Beskrivelse

Inclusion Criteria:

  1. Patients willing to provide informed consent.
  2. Female or male patients aged 18 years or above.
  3. Patients with known case of Type 2 diabetes mellitus.
  4. Patients with inadequate glycaemic control taking metformin monotherapy (minimum dose of 500 mg OD) for at least 3 months.
  5. Patients who have recently (last 15 days) been prescribed saxagliptin in addition to metformin.

Exclusion Criteria:

  1. Patients with Type 1 diabetes mellitus.
  2. Patients taking glucose lowering drugs apart from metformin or saxagliptin.
  3. Any medical condition of the patient which in the opinion of Investigator would interfere with safe completion of the study.
  4. Pregnant or lactating women.
  5. Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication usage in enrolled subjects
Tidsramme: at 3 months
By Frequency of subjects taking different doses of saxagliptin and metformin
at 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction in HbA1C
Tidsramme: baseline and at 3 months
Compare the reduction in HbA1C levels from baseline to follow up visit with baseline HbA1C levels
baseline and at 3 months

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Studiestol: Dr Sanjay Kalra, MD, DM (Endocrinology), Bharti Research Institute of Diabetes & Endocrinology, Karnal
  • Studieleder: Dr Bhavesh P Kotak, FRCS, MS, D Orth, AstraZeneca Pharma India Ltd

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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 (Faktiske)

30. oktober 2015

Primær færdiggørelse (Faktiske)

26. december 2016

Studieafslutning (Faktiske)

26. december 2016

Datoer for studieregistrering

Først indsendt

12. oktober 2015

Først indsendt, der opfyldte QC-kriterier

27. oktober 2015

Først opslået (Skøn)

28. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D1680R00019

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 .

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