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A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

19. marts 2015 opdateret af: AstraZeneca

An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

235

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
      • Aberdeen, Det Forenede Kongerige
        • Research Site
      • Bath, Det Forenede Kongerige
        • Research Site
      • Blackburn, Det Forenede Kongerige
        • Research Site
      • Bolton, Det Forenede Kongerige
        • Research Site
      • Bournemouth, Det Forenede Kongerige
        • Research Site
      • Bristol, Det Forenede Kongerige
        • Research Site
      • Chippenham, Det Forenede Kongerige
        • Research Site
      • Edinburgh, Det Forenede Kongerige
        • Research Site
      • Glasgow, Det Forenede Kongerige
        • Research Site
      • Haywards Heath, Det Forenede Kongerige
        • Research Site
      • High Wycombe, Det Forenede Kongerige
        • Research Site
      • Hull, Det Forenede Kongerige
        • Research Site
      • Ipswich, Det Forenede Kongerige
        • Research Site
      • Kent, Det Forenede Kongerige
        • Research Site
      • Leicester, Det Forenede Kongerige
        • Research Site
      • Liverpool, Det Forenede Kongerige
        • Research Site
      • Livingstone, Det Forenede Kongerige
        • Research Site
      • London, Det Forenede Kongerige
        • Research Site
      • Manchester, Det Forenede Kongerige
        • Research Site
      • Middlesborough, Det Forenede Kongerige
        • Research Site
      • Norwich, Det Forenede Kongerige
        • Research Site
      • Nottingham, Det Forenede Kongerige
        • Research Site
      • Oldham, Det Forenede Kongerige
        • Research Site
      • Oxford, Det Forenede Kongerige
        • Research Site
      • Plymouth, Det Forenede Kongerige
        • Research Site
      • Rochdale, Det Forenede Kongerige
        • Research Site
      • Salford, Det Forenede Kongerige
        • Research Site
      • Swansea, Det Forenede Kongerige
        • Research Site
      • Torquay, Det Forenede Kongerige
        • Research Site
      • Wakefield, Det Forenede Kongerige
        • Research Site
      • Wirral, Det Forenede Kongerige
        • 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

30 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
  • HbA1c between 7.5% and 10.0%.
  • BMI >27.

Exclusion Criteria:

  • Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.
  • Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
  • Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Medicin: exenatid
subkutan injektion, 5mcg eller 10mcg, to gange dagligt
Andre navne:
  • Byetta
Aktiv komparator: 2
Medicin: insulin glargine
subcutaneous injection, titrated to target blood glucose level, once a day
Andre navne:
  • Lantus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
Tidsramme: 26 weeks
Composite endpoint evaluating effect of treatment on glycemic control and weight
26 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg
Tidsramme: 26 weeks
Composite endpoint evaluating effect of treatment on glycemic control and weight
26 weeks
Change in Fasting Serum Glucose
Tidsramme: 26 weeks
Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)
26 weeks
Percent of Patients Achieving HbA1c ≤ 7.4%
Tidsramme: 26 weeks
Percent of patients achieving specified HbA1c target at endpoint
26 weeks
Percent of Patients Achieving HbA1c < 7%
Tidsramme: 26 weeks
Percent of patients achieving specified HbA1c target at endpoint
26 weeks
Percent of Patients Achieving HbA1c < 6.5%
Tidsramme: 26 weeks
Percent of patients achieving specified HbA1c target at endpoint
26 weeks
Change in 7 Point Self Monitored Blood Glucose Profile
Tidsramme: 26 weeks
Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day
26 weeks
Change in Body Mass Index (BMI)
Tidsramme: 26 weeks
Change in BMI from baseline to endpoint
26 weeks
Change in Waist Circumference
Tidsramme: 26 Weeks
Change in waist circumference from baseline to endpoint
26 Weeks
Change in Waist-to-hip Ratio
Tidsramme: 26 weeks
Change in waist-to-hip ratio from baseline to endpoint
26 weeks
Change in Body Weight
Tidsramme: 26 weeks
Change in body weight from baseline to endpoint
26 weeks
Percent Change in Body Weight
Tidsramme: 26 Weeks
Percent change in baseline body weight at endpoint
26 Weeks
Percent of Patients Achieving 5% Weight Loss
Tidsramme: 26 weeks
Percent of patients who lost at least 5% of baseline body weight at endpoint
26 weeks
Percent of Patients Achieving 10% Weight Loss
Tidsramme: 26 weeks
Percent of patients who lost at least 10% of baseline body weight at endpoint
26 weeks
Change in Systolic Blood Pressure
Tidsramme: 26 weeks
Change in systolic blood pressure from baseline to endpoint
26 weeks
Change in Diastolic Blood Pressure
Tidsramme: 26 weeks
Change in diastolic blood pressure from baseline to endpoint
26 weeks
Change in Fasting Serum Total Cholesterol (TC)
Tidsramme: 26 weeks
Change in TC from baseline to endpoint
26 weeks
Change in High Density Lipoprotein (HDL) Cholesterol
Tidsramme: 26 weeks
Change in HDL cholesterol from baseline to endpoint
26 weeks
Change in TC to HDL Cholesterol Ratio
Tidsramme: 26 weeks
Change in TC to HDL cholesterol ratio from baseline to endpoint
26 weeks
Change in Fasting Serum Triglycerides
Tidsramme: 26 weeks
Change in fasting serum triglycerides from baseline to endpoint
26 weeks
Change in Low Density Lipoprotein (LDL) Cholesterol
Tidsramme: 26 weeks
Change in LDL cholesterol from baseline to endpoint
26 weeks
Change in Apolipoprotein-B
Tidsramme: 26 weeks
Change in apolipoprotein-B from baseline to endpoint
26 weeks
Incidence of Hypoglycemic Episodes
Tidsramme: 26 weeks
Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study
26 weeks
Incidence of Nocturnal Hypoglycemic Episodes
Tidsramme: 26 weeks
Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study
26 weeks
Incidence of Severe Hypoglycemic Episodes
Tidsramme: 26 weeks
Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study
26 weeks
Hypoglycemic Rate Per 30 Days
Tidsramme: 26 weeks
Number of hypoglycemic episodes per patient adjusted per 30 days
26 weeks
Nocturnal Hypoglycemic Rate Per 30 Days
Tidsramme: 26 weeks
Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days
26 weeks
Severe Hypoglycemic Rate Per 30 Days
Tidsramme: 26 weeks
Number of severe hypoglycemic episodes per patient adjusted per 30 days
26 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Samarbejdspartnere

Eli Lilly and Company

Efterforskere

  • Studieleder: Mauricio Silva de Lima, MD, Eli Lilly and Company

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. juni 2006

Primær færdiggørelse (Faktiske)

1. april 2008

Studieafslutning (Faktiske)

1. april 2008

Datoer for studieregistrering

Først indsendt

2. august 2006

Først indsendt, der opfyldte QC-kriterier

2. august 2006

Først opslået (Skøn)

4. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H8O-BP-GWBG

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

Kliniske forsøg med exenatid

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Betingelser

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