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The OBSTACLE Hypoglycemia Study (MK-0000-158)

1. april 2015 opdateret af: Merck Sharp & Dohme LLC

Prospective Observational Study to Assess Correlation Between Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes Treated With Sulfonylurea

This study will assess the correlation between glycemic control and the hypoglycemia symptom score in patients with Type 2 diabetes, 12 weeks after addition of a sulfonylurea to an ongoing regime of oral hypoglycemic agents.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients will be evaluated for participation in the study during their usual visit to participating diabetes care clinics. Addition of sulfonylurea will be an unbiased decision of the participating physicians based on the clinical needs of the participating patients.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1069

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Diabetic clinic patients

Beskrivelse

Inclusion Criteria:

  • Patients with Type 2 Diabetes, of either gender and aged between 18-75 years
  • Patients being considered for addition of Sulfonylurea on background of at least one other oral hypoglycemic agent, on a usual visit (screening cum enrolment visit), as per the clinical situation judged by participating physician
  • Willing to comply with study requirements

Exclusion Criteria:

  • Patients with type 1 Diabetes or gestational Diabetes
  • Patients currently on insulin therapy or have received Insulin in last 6 months
  • Patients currently on Sulfonylurea therapy or have received Sulfonylureas in last 6 months
  • Patients currently on Meglitinides therapy or have received Meglitinides in last 6 months
  • Patients initiated on Sulfonylurea monotherapy
  • Patient on DPP-4 inhibitors, either as monotherapy or as combination therapy
  • Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
  • Patients for whom it would be impossible to complete the questionnaire for whatever reason, in any feasible form
  • Patients who are already participating in a clinical trial or other clinical study

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
All participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s).
Medicin: Sulfonylurea
The dose and frequency of administration of study drug (sulfonylurea) was decided by the investigator according to the individual need of each participant.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores
Tidsramme: Week 12
Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.
Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Tidsramme: Week 12
Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12.
Week 12
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Tidsramme: Week 12
Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.
Week 12
Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12
Tidsramme: Baseline and Week 12
Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases.
Baseline and Week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Merck Sharp & Dohme LLC

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

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. august 2009

Primær færdiggørelse (Faktiske)

1. maj 2010

Studieafslutning (Faktiske)

1. maj 2010

Datoer for studieregistrering

Først indsendt

21. maj 2009

Først indsendt, der opfyldte QC-kriterier

22. maj 2009

Først opslået (Skøn)

25. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0000-158
  • 2009_001

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 2 diabetes

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner