Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
21 de outubro de 2016 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
261
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Arizona
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Peoria, Arizona, Estados Unidos
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Phoenix, Arizona, Estados Unidos
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California
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Buena Park, California, Estados Unidos
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Concord, California, Estados Unidos
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Fresno, California, Estados Unidos
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Greenbrae, California, Estados Unidos
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La Mesa, California, Estados Unidos
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Lancaster, California, Estados Unidos
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Northridge, California, Estados Unidos
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Palm Springs, California, Estados Unidos
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Salinas, California, Estados Unidos
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Florida
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Hollywood, Florida, Estados Unidos
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Jacksonville, Florida, Estados Unidos
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Georgia
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Atlanta, Georgia, Estados Unidos
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Hawaii
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Honolulu, Hawaii, Estados Unidos
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Idaho
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Idaho Falls, Idaho, Estados Unidos
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Iowa
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Des Moines, Iowa, Estados Unidos
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Kansas
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Wichita, Kansas, Estados Unidos
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos
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Lafayette, Louisiana, Estados Unidos
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Matairie, Louisiana, Estados Unidos
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Massachusetts
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Boston, Massachusetts, Estados Unidos
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Minnesota
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Minneapolis, Minnesota, Estados Unidos
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Missouri
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Chesterfield, Missouri, Estados Unidos
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St Louis, Missouri, Estados Unidos
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Nebraska
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Omaha, Nebraska, Estados Unidos
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Nevada
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Las Vegas, Nevada, Estados Unidos
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New Jersey
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Berkeley Heights, New Jersey, Estados Unidos
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Teaneck, New Jersey, Estados Unidos
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New Mexico
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Alburquerque, New Mexico, Estados Unidos
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New York
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New York, New York, Estados Unidos
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North Carolina
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Durham, North Carolina, Estados Unidos
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Oregon
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Bend, Oregon, Estados Unidos
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Texas
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Dallas, Texas, Estados Unidos
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El Paso, Texas, Estados Unidos
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Georgetown, Texas, Estados Unidos
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San Antonio, Texas, Estados Unidos
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Virginia
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Richmond, Virginia, Estados Unidos
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Washington
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Vancouver, Washington, Estados Unidos
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Wisconsin
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Kenosha, Wisconsin, Estados Unidos
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Athens, Grécia
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Thessaloniki, Grécia
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Holon, Israel
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Kfar Sava, Israel
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Tel Hashomer, Israel
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Coatzacoalcos, México
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Mexico, México
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Monterrey, México
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Carolina, Porto Rico
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Hato Rey, Porto Rico
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Ponce, Porto Rico
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San Juan, Porto Rico
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Birmingham, Reino Unido
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Guildford, Reino Unido
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Leicester, Reino Unido
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Livingston, Reino Unido
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Middlesbrough, Reino Unido
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Swansea, Reino Unido
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Torquay, Reino Unido
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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:
- metformin (stable dose for 6 weeks)
- pioglitazone (stable dose for 6 weeks)
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 2
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injeção subcutânea, duas vezes ao dia, 10mcg
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Comparador de Placebo: 1
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injeção subcutânea, duas vezes ao dia
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Glycosylated Hemoglobin (HbA1c)
Prazo: baseline and 30 weeks
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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.
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baseline and 30 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Patients Achieving HbA1c <=7%
Prazo: baseline and 30 weeks
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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%).
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baseline and 30 weeks
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Percentage of Patients Achieving HbA1c <=6.5%
Prazo: baseline and 30 weeks
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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%).
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baseline and 30 weeks
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Change in Fasting Serum Glucose
Prazo: baseline and 30 weeks
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Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)
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baseline and 30 weeks
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Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Prazo: baseline and 30 weeks
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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)
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baseline and 30 weeks
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Change in Total Cholesterol
Prazo: baseline and 30 weeks
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Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)
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baseline and 30 weeks
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Change in Low Density Lipoprotein (LDL) Cholesterol
Prazo: baseline and 30 weeks
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Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)
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baseline and 30 weeks
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Change in High Density Lipoprotein (HDL) Cholesterol
Prazo: baseline and 30 weeks
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Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)
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baseline and 30 weeks
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Change in Triglycerides
Prazo: baseline and 30 weeks
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Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)
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baseline and 30 weeks
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Change in Body Weight
Prazo: baseline and 30 weeks
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Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)
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baseline and 30 weeks
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Change in Waist Circumference
Prazo: baseline and 30 weeks
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Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)
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baseline and 30 weeks
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Change in Daily Insulin Dose
Prazo: baseline and 30 weeks
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Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)
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baseline and 30 weeks
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Change in Daily Insulin Dose (on a Per Body Weight Basis)
Prazo: baseline and 30 weeks
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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)
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baseline and 30 weeks
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Change in Systolic Blood Pressure (SBP)
Prazo: baseline and 30 weeks
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Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)
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baseline and 30 weeks
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Change in Diastolic Blood Pressure (DBP)
Prazo: baseline and 30 weeks
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Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)
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baseline and 30 weeks
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Minor Hypoglycemia Rate Per Year
Prazo: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
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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).
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baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
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Percentage of Subjects Experiencing Minor Hypoglycemia
Prazo: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
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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).
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baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- Buse JB, Han J, Miller S, MacConell L, Pencek R, Wintle M. Addition of exenatide BID to insulin glargine: a post-hoc analysis of the effect on glycemia and weight across a range of insulin titration. Curr Med Res Opin. 2014 Jul;30(7):1209-18. doi: 10.1185/03007995.2014.896329. Epub 2014 Mar 18.
- Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, Endahl L, Mathieu C; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care. 2012 Dec;35(12):2464-71. doi: 10.2337/dc12-1205. Epub 2012 Oct 5.
- Rosenstock J, Shenouda SK, Bergenstal RM, Buse JB, Glass LC, Heilmann CR, Kwan AY, MacConell LA, Hoogwerf BJ. Baseline factors associated with glycemic control and weight loss when exenatide twice daily is added to optimized insulin glargine in patients with type 2 diabetes. Diabetes Care. 2012 May;35(5):955-8. doi: 10.2337/dc11-1434. Epub 2012 Mar 19.
- Buse JB, Bergenstal RM, Glass LC, Heilmann CR, Lewis MS, Kwan AY, Hoogwerf BJ, Rosenstock J. Use of twice-daily exenatide in Basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011 Jan 18;154(2):103-12. doi: 10.7326/0003-4819-154-2-201101180-00300. Epub 2010 Dec 6.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de outubro de 2008
Conclusão Primária (Real)
1 de janeiro de 2010
Conclusão do estudo (Real)
1 de janeiro de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
1 de outubro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de outubro de 2008
Primeira postagem (Estimativa)
3 de outubro de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
24 de outubro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de outubro de 2016
Última verificação
1 de outubro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H8O-US-GWCO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .