A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
19. mars 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
235
Fase
- Fase 3
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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Aberdeen, Storbritannia
- Research Site
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Bath, Storbritannia
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Blackburn, Storbritannia
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Bolton, Storbritannia
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Bournemouth, Storbritannia
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Bristol, Storbritannia
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Chippenham, Storbritannia
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Edinburgh, Storbritannia
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Glasgow, Storbritannia
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Haywards Heath, Storbritannia
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High Wycombe, Storbritannia
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Hull, Storbritannia
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Ipswich, Storbritannia
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Kent, Storbritannia
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Leicester, Storbritannia
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Liverpool, Storbritannia
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Livingstone, Storbritannia
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London, Storbritannia
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Manchester, Storbritannia
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Middlesborough, Storbritannia
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Norwich, Storbritannia
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Nottingham, Storbritannia
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Oldham, Storbritannia
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Oxford, Storbritannia
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Plymouth, Storbritannia
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Rochdale, Storbritannia
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Salford, Storbritannia
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Swansea, Storbritannia
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Torquay, Storbritannia
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Wakefield, Storbritannia
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Wirral, Storbritannia
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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
30 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 1
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subkutan injeksjon, 5mcg eller 10mcg, to ganger daglig
Andre navn:
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Aktiv komparator: 2
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subcutaneous injection, titrated to target blood glucose level, once a day
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
Tidsramme: 26 weeks
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Composite endpoint evaluating effect of treatment on glycemic control and weight
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26 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg
Tidsramme: 26 weeks
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Composite endpoint evaluating effect of treatment on glycemic control and weight
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26 weeks
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Change in Fasting Serum Glucose
Tidsramme: 26 weeks
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Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)
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26 weeks
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Percent of Patients Achieving HbA1c ≤ 7.4%
Tidsramme: 26 weeks
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Percent of patients achieving specified HbA1c target at endpoint
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26 weeks
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Percent of Patients Achieving HbA1c < 7%
Tidsramme: 26 weeks
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Percent of patients achieving specified HbA1c target at endpoint
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26 weeks
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Percent of Patients Achieving HbA1c < 6.5%
Tidsramme: 26 weeks
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Percent of patients achieving specified HbA1c target at endpoint
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26 weeks
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Change in 7 Point Self Monitored Blood Glucose Profile
Tidsramme: 26 weeks
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Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day
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26 weeks
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Change in Body Mass Index (BMI)
Tidsramme: 26 weeks
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Change in BMI from baseline to endpoint
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26 weeks
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Change in Waist Circumference
Tidsramme: 26 Weeks
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Change in waist circumference from baseline to endpoint
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26 Weeks
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Change in Waist-to-hip Ratio
Tidsramme: 26 weeks
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Change in waist-to-hip ratio from baseline to endpoint
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26 weeks
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Change in Body Weight
Tidsramme: 26 weeks
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Change in body weight from baseline to endpoint
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26 weeks
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Percent Change in Body Weight
Tidsramme: 26 Weeks
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Percent change in baseline body weight at endpoint
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26 Weeks
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Percent of Patients Achieving 5% Weight Loss
Tidsramme: 26 weeks
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Percent of patients who lost at least 5% of baseline body weight at endpoint
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26 weeks
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Percent of Patients Achieving 10% Weight Loss
Tidsramme: 26 weeks
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Percent of patients who lost at least 10% of baseline body weight at endpoint
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26 weeks
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Change in Systolic Blood Pressure
Tidsramme: 26 weeks
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Change in systolic blood pressure from baseline to endpoint
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26 weeks
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Change in Diastolic Blood Pressure
Tidsramme: 26 weeks
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Change in diastolic blood pressure from baseline to endpoint
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26 weeks
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Change in Fasting Serum Total Cholesterol (TC)
Tidsramme: 26 weeks
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Change in TC from baseline to endpoint
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26 weeks
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Change in High Density Lipoprotein (HDL) Cholesterol
Tidsramme: 26 weeks
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Change in HDL cholesterol from baseline to endpoint
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26 weeks
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Change in TC to HDL Cholesterol Ratio
Tidsramme: 26 weeks
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Change in TC to HDL cholesterol ratio from baseline to endpoint
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26 weeks
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Change in Fasting Serum Triglycerides
Tidsramme: 26 weeks
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Change in fasting serum triglycerides from baseline to endpoint
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26 weeks
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Change in Low Density Lipoprotein (LDL) Cholesterol
Tidsramme: 26 weeks
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Change in LDL cholesterol from baseline to endpoint
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26 weeks
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Change in Apolipoprotein-B
Tidsramme: 26 weeks
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Change in apolipoprotein-B from baseline to endpoint
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26 weeks
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Incidence of Hypoglycemic Episodes
Tidsramme: 26 weeks
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Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study
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26 weeks
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Incidence of Nocturnal Hypoglycemic Episodes
Tidsramme: 26 weeks
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Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study
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26 weeks
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Incidence of Severe Hypoglycemic Episodes
Tidsramme: 26 weeks
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Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study
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26 weeks
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Hypoglycemic Rate Per 30 Days
Tidsramme: 26 weeks
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Number of hypoglycemic episodes per patient adjusted per 30 days
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26 weeks
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Nocturnal Hypoglycemic Rate Per 30 Days
Tidsramme: 26 weeks
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Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days
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26 weeks
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Severe Hypoglycemic Rate Per 30 Days
Tidsramme: 26 weeks
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Number of severe hypoglycemic episodes per patient adjusted per 30 days
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26 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Mauricio Silva de Lima, MD, Eli Lilly and Company
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
- Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009 Dec;11(12):1153-62. doi: 10.1111/j.1463-1326.2009.01154.x.
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. juni 2006
Primær fullføring (Faktiske)
1. april 2008
Studiet fullført (Faktiske)
1. april 2008
Datoer for studieregistrering
Først innsendt
2. august 2006
Først innsendt som oppfylte QC-kriteriene
2. august 2006
Først lagt ut (Anslag)
4. august 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. april 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mars 2015
Sist bekreftet
1. mars 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Kroppsvekt
- Endringer i kroppsvekt
- Sukkersyke
- Diabetes mellitus, type 2
- Vektøkning
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Midler mot fedme
- Inkretiner
- Insulin Glargine
- Exenatid
Andre studie-ID-numre
- H8O-BP-GWBG
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. .