Comparison of Two Basal Insulins for Patients With Type 2 Diabetes on Anti-Hyperglycemic Medications (IOPE) (IOPE)
12 de outubro de 2010 atualizado por: Eli Lilly and Company
The PERSISTENT Trial: A Prospective Randomized Trial Comparing Insulin Lispro Protamine Suspension to Insulin Glargine in Patients With Type 2 Diabetes on Anti-hyperglycemic Medications
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
471
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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Brasilia, Brasil, 71625-009
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fortaleza, Brasil, 60430-350
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Joinville, Brasil, 89201-260
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Sao Paulo, Brasil, 01244-030
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British Columbia
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Victoria, British Columbia, Canadá, V8R 6V4
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arkansas
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Jonesboro, Arkansas, Estados Unidos, 72401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Huntington Park, California, Estados Unidos, 90255
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Florida
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Miami, Florida, Estados Unidos, 33145
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Georgia
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Atlanta, Georgia, Estados Unidos, 30312
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46222
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kansas
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Wichita, Kansas, Estados Unidos, 67208
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40502
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Louisiana
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Slidell, Louisiana, Estados Unidos, 70458
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
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Toms River, New Jersey, Estados Unidos, 08755
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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Brooklyn, New York, Estados Unidos, 11203
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ponce, Porto Rico, 00716
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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 mellitus for at least 1 year.
- Are greater than or equal to 18 years old.
- Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin- Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs)
- Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
- Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared.
Exclusion Criteria:
- Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- Have taken any glucose-lowering medications not included in Inclusion Criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
- Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
- Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
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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Experimental: Lispro
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
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Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
Outros nomes:
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Comparador Ativo: Glargine
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
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Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Prazo: Baseline, 24 Weeks
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Baseline, 24 Weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value
Prazo: Baseline, 12 Weeks, 24 Weeks
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Baseline, 12 Weeks, 24 Weeks
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Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint
Prazo: 24 weeks
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Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7% and less than or equal to 6.5% at endpoint.
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24 weeks
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Glycemic Variability at Endpoint
Prazo: 24 weeks
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Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitoring blood glucose (SMBG) profiles at endpoint) based on the actual morning pre-meal blood glucose.
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24 weeks
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7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint
Prazo: 24 weeks
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Actual measurements and daily mean blood glucose levels at endpoint.
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24 weeks
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Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall
Prazo: Baseline to 24 weeks
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Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe Hypoglycemia: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with either a Roche blood glucose value <2.8 millimoles/liter or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
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Baseline to 24 weeks
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1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Prazo: Baseline to 24 weeks
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Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
1-year adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 365.25 days.
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Baseline to 24 weeks
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30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall
Prazo: Baseline to 24 Weeks
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Overall: any time after randomization.
Hypoglycemic: any time patient experienced sign/symptom associated with hypoglycemia, or had old Roche blood glucose level <7 mg/dL.
Nocturnal: any hypoglycemic event that occurred between bedtime and waking.
Severe: event with symptoms consistent with neuroglycopenia in which patient requires assistance, and is associated with: a Roche blood glucose value <2.8 mmol/L or prompt recovery after oral carbohydrate, glucagon, or IV glucose.
30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days.
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Baseline to 24 Weeks
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Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint
Prazo: Baseline, 24 weeks
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Baseline, 24 weeks
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Total Daily Insulin Dose (Units) at Endpoint
Prazo: 24 weeks
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Insulin dose at endpoint was analyzed by 24-hour total daily insulin (units).
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24 weeks
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Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint
Prazo: 24 Weeks
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Insulin dose at endpoint was analyzed by 24-hour total daily insulin per body weight (units/kilograms).
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24 Weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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
- Strojek K, Shi C, Carey MA, Jacober SJ. Addition of insulin lispro protamine suspension or insulin glargine to oral type 2 diabetes regimens: a randomized trial. Diabetes Obes Metab. 2010 Oct;12(10):916-22. doi: 10.1111/j.1463-1326.2010.01257.x.
- Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
Links úteis
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 agosto de 2007
Conclusão Primária (Real)
1 de outubro de 2008
Conclusão do estudo (Real)
1 de outubro de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
1 de agosto de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de agosto de 2007
Primeira postagem (Estimativa)
3 de agosto de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
21 de outubro de 2010
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de outubro de 2010
Última verificação
1 de outubro de 2010
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
- 11813
- F3Z-MC-IOPE (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 .