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Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus

21 oktober 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

261

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 2
Läkemedel: exenatid
subkutan injektion, två gånger om dagen, 10mcg
Placebo-jämförare: 1
Läkemedel: placebo
subkutan injektion, två gånger om dagen

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Glycosylated Hemoglobin (HbA1c)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Patients Achieving HbA1c <=7%
Tidsram: 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%
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AstraZeneca

Samarbetspartners

Eli Lilly and Company

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2008

Primärt slutförande (Faktisk)

1 januari 2010

Avslutad studie (Faktisk)

1 januari 2010

Studieregistreringsdatum

Först inskickad

1 oktober 2008

Först inskickad som uppfyllde QC-kriterierna

1 oktober 2008

Första postat (Uppskatta)

3 oktober 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 oktober 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 oktober 2016

Senast verifierad

1 oktober 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • H8O-US-GWCO

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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