Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

21 oktober 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

261

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 2
Geneesmiddel: exenatide
subcutane injectie, tweemaal daags, 10mcg
Placebo-vergelijker: 1
Geneesmiddel: placebo
subcutane injectie, tweemaal daags

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Glycosylated Hemoglobin (HbA1c)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Patients Achieving HbA1c <=7%
Tijdsspanne: 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%
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Medewerkers

Eli Lilly and Company

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2008

Primaire voltooiing (Werkelijk)

1 januari 2010

Studie voltooiing (Werkelijk)

1 januari 2010

Studieregistratiedata

Eerst ingediend

1 oktober 2008

Eerst ingediend dat voldeed aan de QC-criteria

1 oktober 2008

Eerst geplaatst (Schatting)

3 oktober 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

24 oktober 2016

Laatste update ingediend die voldeed aan QC-criteria

21 oktober 2016

Laatst geverifieerd

1 oktober 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H8O-US-GWCO

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren