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Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

21 ottobre 2016 aggiornato da: AstraZeneca

A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

261

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Grecia
      • Athens, Grecia
        • Research Site
      • Thessaloniki, Grecia
        • Research Site
  • Israele
      • Holon, Israele
        • Research Site
      • Kfar Sava, Israele
        • Research Site
      • Tel Hashomer, Israele
        • Research Site
  • Messico
      • Coatzacoalcos, Messico
        • Research Site
      • Mexico, Messico
        • Research Site
      • Monterrey, Messico
        • Research Site
  • Porto Rico
      • Carolina, Porto Rico
        • Research Site
      • Hato Rey, Porto Rico
        • Research Site
      • Ponce, Porto Rico
        • Research Site
      • San Juan, Porto Rico
        • Research Site
  • Regno Unito
      • Birmingham, Regno Unito
        • Research Site
      • Guildford, Regno Unito
        • Research Site
      • Leicester, Regno Unito
        • Research Site
      • Livingston, Regno Unito
        • Research Site
      • Middlesbrough, Regno Unito
        • Research Site
      • Swansea, Regno Unito
        • Research Site
      • Torquay, Regno Unito
        • Research Site
  • Stati Uniti
    • Arizona
      • Peoria, Arizona, Stati Uniti
        • Research Site
      • Phoenix, Arizona, Stati Uniti
        • Research Site
    • California
      • Buena Park, California, Stati Uniti
        • Research Site
      • Concord, California, Stati Uniti
        • Research Site
      • Fresno, California, Stati Uniti
        • Research Site
      • Greenbrae, California, Stati Uniti
        • Research Site
      • La Mesa, California, Stati Uniti
        • Research Site
      • Lancaster, California, Stati Uniti
        • Research Site
      • Northridge, California, Stati Uniti
        • Research Site
      • Palm Springs, California, Stati Uniti
        • Research Site
      • Salinas, California, Stati Uniti
        • Research Site
    • Florida
      • Hollywood, Florida, Stati Uniti
        • Research Site
      • Jacksonville, Florida, Stati Uniti
        • Research Site
    • Georgia
      • Atlanta, Georgia, Stati Uniti
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, Stati Uniti
        • Research Site
    • Iowa
      • Des Moines, Iowa, Stati Uniti
        • Research Site
    • Kansas
      • Wichita, Kansas, Stati Uniti
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti
        • Research Site
      • Lafayette, Louisiana, Stati Uniti
        • Research Site
      • Matairie, Louisiana, Stati Uniti
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti
        • Research Site
    • Missouri
      • Chesterfield, Missouri, Stati Uniti
        • Research Site
      • St Louis, Missouri, Stati Uniti
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Stati Uniti
        • Research Site
    • Nevada
      • Las Vegas, Nevada, Stati Uniti
        • Research Site
    • New Jersey
      • Berkeley Heights, New Jersey, Stati Uniti
        • Research Site
      • Teaneck, New Jersey, Stati Uniti
        • Research Site
    • New Mexico
      • Alburquerque, New Mexico, Stati Uniti
        • Research Site
    • New York
      • New York, New York, Stati Uniti
        • Research Site
    • North Carolina
      • Durham, North Carolina, Stati Uniti
        • Research Site
    • Oregon
      • Bend, Oregon, Stati Uniti
        • Research Site
    • Texas
      • Dallas, Texas, Stati Uniti
        • Research Site
      • El Paso, Texas, Stati Uniti
        • Research Site
      • Georgetown, Texas, Stati Uniti
        • Research Site
      • San Antonio, Texas, Stati Uniti
        • Research Site
    • Virginia
      • Richmond, Virginia, Stati Uniti
        • Research Site
    • Washington
      • Vancouver, Washington, Stati Uniti
        • Research Site
    • Wisconsin
      • Kenosha, Wisconsin, Stati Uniti
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Have type 2 diabetes.
  • Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study.

Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study:

  1. metformin (stable dose for 6 weeks)
  2. pioglitazone (stable dose for 6 weeks)

  3. a combination of metformin and pioglitazone (stable dose for 6 weeks)

    • Have HbA1C between 7.1% and 10.5%, inclusive.
    • Have a body mass index (BMI) ≤45 kg/m2.
    • Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).

Exclusion Criteria:

  • Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study.
  • Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study.
  • Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control.
  • Women who are breastfeeding.
  • Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer.
  • Have had a kidney transplant or are currently on kidney dialysis.
  • Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years.
  • Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients.
  • Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study.
  • Are currently on a weight-loss program or have been on one within 3 months of entering the study.
  • Have had a blood transfusion or severe blood loss within 3 months of entering the study.
  • Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study.
  • Have an irregular sleep cycle (for example, sleeping during the day and working during the night).
  • Have a history of pancreatitis.
  • Have received treatment with an experimental drug within 30 days of entering the study.
  • If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis.
  • If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study.
  • If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 2
Droga: exenatide
iniezione sottocutanea, due volte al giorno, 10mcg
Comparatore placebo: 1
Droga: placebo
iniezione sottocutanea, due volte al giorno

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Glycosylated Hemoglobin (HbA1c)
Lasso di tempo: baseline and 30 weeks
Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.
baseline and 30 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Patients Achieving HbA1c <=7%
Lasso di tempo: baseline and 30 weeks
Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).
baseline and 30 weeks
Percentage of Patients Achieving HbA1c <=6.5%
Lasso di tempo: baseline and 30 weeks
Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).
baseline and 30 weeks
Change in Fasting Serum Glucose
Lasso di tempo: baseline and 30 weeks
Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)
baseline and 30 weeks
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Lasso di tempo: baseline and 30 weeks
Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)
baseline and 30 weeks
Change in Total Cholesterol
Lasso di tempo: baseline and 30 weeks
Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)
baseline and 30 weeks
Change in Low Density Lipoprotein (LDL) Cholesterol
Lasso di tempo: baseline and 30 weeks
Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)
baseline and 30 weeks
Change in High Density Lipoprotein (HDL) Cholesterol
Lasso di tempo: baseline and 30 weeks
Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)
baseline and 30 weeks
Change in Triglycerides
Lasso di tempo: baseline and 30 weeks
Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)
baseline and 30 weeks
Change in Body Weight
Lasso di tempo: baseline and 30 weeks
Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)
baseline and 30 weeks
Change in Waist Circumference
Lasso di tempo: baseline and 30 weeks
Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)
baseline and 30 weeks
Change in Daily Insulin Dose
Lasso di tempo: baseline and 30 weeks
Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)
baseline and 30 weeks
Change in Daily Insulin Dose (on a Per Body Weight Basis)
Lasso di tempo: baseline and 30 weeks
Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)
baseline and 30 weeks
Change in Systolic Blood Pressure (SBP)
Lasso di tempo: baseline and 30 weeks
Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)
baseline and 30 weeks
Change in Diastolic Blood Pressure (DBP)
Lasso di tempo: baseline and 30 weeks
Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)
baseline and 30 weeks
Minor Hypoglycemia Rate Per Year
Lasso di tempo: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Percentage of Subjects Experiencing Minor Hypoglycemia
Lasso di tempo: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).
baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Collaboratori

Eli Lilly and Company

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2008

Completamento primario (Effettivo)

1 gennaio 2010

Completamento dello studio (Effettivo)

1 gennaio 2010

Date di iscrizione allo studio

Primo inviato

1 ottobre 2008

Primo inviato che soddisfa i criteri di controllo qualità

1 ottobre 2008

Primo Inserito (Stima)

3 ottobre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 ottobre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 ottobre 2016

Ultimo verificato

1 ottobre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H8O-US-GWCO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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