Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
12 de janeiro de 2011 atualizado por: Eli Lilly and Company
A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide
This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
339
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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Phoenix, Arizona, Estados Unidos, 85028
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California
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Concord, California, Estados Unidos, 94520
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Escondido, California, Estados Unidos, 92026
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Fresno, California, Estados Unidos, 93720
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Modesto, California, Estados Unidos, 95355
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Orange, California, Estados Unidos, 92869
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Florida
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Inverness, Florida, Estados Unidos, 34452
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Jacksonville, Florida, Estados Unidos, 32204
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Lake Worth, Florida, Estados Unidos, 33461
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Miami, Florida, Estados Unidos, 33183
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Orlando, Florida, Estados Unidos, 32804
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Palm Harbor, Florida, Estados Unidos, 34684
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Pembroke Pines, Florida, Estados Unidos, 33029
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Plantation, Florida, Estados Unidos, 33324
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West Palm Beach, Florida, Estados Unidos, 33401
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83404
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Indiana
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Avon, Indiana, Estados Unidos, 46123
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Bloomington, Indiana, Estados Unidos, 47403
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South Bend, Indiana, Estados Unidos, 46617
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Iowa
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Des Moines, Iowa, Estados Unidos, 50314
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
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Lafayette, Louisiana, Estados Unidos, 70503
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Metairie, Louisiana, Estados Unidos, 70006
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Maine
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Biddeford, Maine, Estados Unidos, 04005
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Missouri
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Chesterfield, Missouri, Estados Unidos, 63017
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Jefferson City, Missouri, Estados Unidos, 65109
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St Louis, Missouri, Estados Unidos, 63104
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68131
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89148
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New Hampshire
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Nashua, New Hampshire, Estados Unidos, 03063
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New York
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Rochester, New York, Estados Unidos, 14607
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Syracuse, New York, Estados Unidos, 13210
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North Carolina
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Morehead City, North Carolina, Estados Unidos, 28557
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Ohio
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London, Ohio, Estados Unidos, 43140
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Mason, Ohio, Estados Unidos, 45040
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Toledo, Ohio, Estados Unidos, 43606
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South Carolina
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Greer, South Carolina, Estados Unidos, 29651
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Myrtle Beach, South Carolina, Estados Unidos, 29572
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Tennessee
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Kingsport, Tennessee, Estados Unidos, 37660
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Memphis, Tennessee, Estados Unidos, 38119
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Texas
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Austin, Texas, Estados Unidos, 78731
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Dallas, Texas, Estados Unidos, 75231
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San Antonio, Texas, Estados Unidos, 78229
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Vermont
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South Burlington, Vermont, Estados Unidos, 05403
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Virginia
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Virginia Beach, Virginia, Estados Unidos, 23462
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Washington
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Spokane, Washington, Estados Unidos, 99202
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Vancouver, Washington, Estados Unidos, 98664
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Ponce, Porto Rico, 00731
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Toa Baja, Porto Rico, 00949
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Yabucoa, Porto Rico, 00767
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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 a 74 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Must have type 2 diabetes
- Must be at least 18 years of age and less than 75 years of age
- Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
- Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
- Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%
Exclusion Criteria:
- Must not have used insulin on a regular basis during the past 2 years
- Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
- Must not have had more than one episode of severe hypoglycemia in the past 6 months
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
- Must not be pregnant or intend to get pregnant during the course of the study
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: ILPS
Insulin Lispro Protamine Suspension (ILPS)
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Administered subcutaneously once a day at bedtime
Outros nomes:
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Comparador Ativo: Glargine
Insulin Glargine
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Administered subcutaneously once a day at bedtime
Outros nomes:
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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 From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])
Prazo: Baseline, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.
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Baseline, Endpoint (LOCF) up to 24 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Prazo: 24 weeks, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
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24 weeks, Endpoint (LOCF) up to 24 weeks
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Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)
Prazo: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
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Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
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Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks
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Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%
Prazo: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks
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7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)
Prazo: Baseline, Endpoint (LOCF) up to 24 weeks
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SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours.
Post-prandial glucose is measured 2 hours after the start of the meal.
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Baseline, Endpoint (LOCF) up to 24 weeks
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Glycemic Variability at Baseline and Endpoint (LOCF)
Prazo: Baseline, Endpoint (LOCF) up to 24 weeks
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Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose.
Mean SD was calculated based on the SD for each participant in the study.
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Baseline, Endpoint (LOCF) up to 24 weeks
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Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)
Prazo: Baseline to Endpoint (LOCF) up to 24 weeks
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Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL.
Non-nocturnal:any episode that occurred between waking and bedtime.
Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value <50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)*100.
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Baseline to Endpoint (LOCF) up to 24 weeks
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Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)
Prazo: Baseline to Endpoint (LOCF) up to 24 weeks
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Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall.
Rate is reported as episodes/participant/365 days.
Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment.
Overall=any time during the post-randomization visits within the study period.
Nocturnal=Any episode that occurs between bedtime and waking.
Non-Nocturnal=Any episode that occurs between waking and bedtime.
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Baseline to Endpoint (LOCF) up to 24 weeks
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Actual Body Weight at Baseline and Endpoint (LOCF)
Prazo: Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
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|
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Change From Baseline in Body Weight at Endpoint (LOCF)
Prazo: Baseline, Endpoint (LOCF) up to 24 weeks
|
Baseline, Endpoint (LOCF) up to 24 weeks
|
|
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Total Daily Insulin Dose at Endpoint (LOCF)
Prazo: Endpoint (LOCF) up to 24 weeks
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Endpoint (LOCF) up to 24 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 novembro de 2007
Conclusão Primária (Real)
1 de dezembro de 2009
Conclusão do estudo (Real)
1 de dezembro de 2009
Datas de inscrição no estudo
Enviado pela primeira vez
15 de novembro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de novembro de 2007
Primeira postagem (Estimativa)
19 de novembro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
13 de janeiro de 2011
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de janeiro de 2011
Última verificação
1 de janeiro de 2011
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Doenças do Sistema Endócrino
- Diabetes Mellitus
- Diabetes Mellitus, Tipo 2
- Hipoglicemiantes
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Coagulantes
- Antagonistas da Heparina
- Insulina
- Insulina, Globina Zinco
- Insulina Glargina
- Insulina Lispro
- Protaminas
Outros números de identificação do estudo
- 11647
- F3Z-US-IOPB (Outro identificador: Eli Lilly and Company)
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 .