Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY) (IOOY)
4 de novembro de 2009 atualizado por: Eli Lilly and Company
Treat-to-Target Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Comparator) in Basal Therapy for Patients With Type 2 Diabetes Mellitus
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes.
A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
442
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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Buenos Aires, Argentina, C1188AAF
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Ramos Mejia, Argentina, B1704ETD
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Lugo, Espanha, 27004
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Palma de Mallorca, Espanha, 07014
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Santa Cruz de Tenerife, Espanha, 38320
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Valencia, Espanha, 46015
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Alabama
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Hueytown, Alabama, Estados Unidos, 35023
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Arizona
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Litchfield Park, Arizona, Estados Unidos, 85340
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Phoenix, Arizona, Estados Unidos, 85016
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California
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Buena Park, California, Estados Unidos, 90620
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Fountain Valley, California, Estados Unidos, 92708
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Los Angeles, California, Estados Unidos, 90057
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Florida
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Jacksonville, Florida, Estados Unidos, 32257
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Georgia
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Atlanta, Georgia, Estados Unidos, 30312
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
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Indiana
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Evansville, Indiana, Estados Unidos, 47714
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Indianapolis, Indiana, Estados Unidos, 46202
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Newburgh, Indiana, Estados Unidos, 47630
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
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Louisiana
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Slidell, Louisiana, Estados Unidos, 70458
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Maryland
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Prince Frederick, Maryland, Estados Unidos, 20678
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Michigan
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Novi, Michigan, Estados Unidos, 48374
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89101
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New York
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Syracuse, New York, Estados Unidos, 13210
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North Carolina
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Goldsboro, North Carolina, Estados Unidos, 27530
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45236
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London, Ohio, Estados Unidos, 43140
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Oregon
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Bend, Oregon, Estados Unidos, 97701
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Pennsylvania
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Lansdale, Pennsylvania, Estados Unidos, 19446
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South Carolina
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Taylors, South Carolina, Estados Unidos, 29687
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Tennessee
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Johnson City, Tennessee, Estados Unidos, 37604
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Texas
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Grand Prairie, Texas, Estados Unidos, 75052
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Wisconsin
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Menomonee Falls, Wisconsin, Estados Unidos, 53051
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Budapest, Hungria, H-1139
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Eger, Hungria, 3300
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Mako, Hungria, 6900
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Szekesfehervar, Hungria, 8000
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Szekszard, Hungria, 7100
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Veszprem, Hungria, 8200
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Chihuahua, México, 31238
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Guadalajara, México, 44340
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Krakow, Polônia, 30-349
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Poznan, Polônia, 61-495
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Rzeszow, Polônia, 35-068
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Goyang-Si, Republica da Coréia, 410-719
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Sungnam-Si, Republica da Coréia, 463-712
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Chiayi City, Taiwan, 600
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Neihu Taipei, Taiwan, 114
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Tainan, Taiwan, 704
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Taipei, Taiwan, 100
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Yung-Kang, Tainan, Taiwan, 710
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Bangalore, Índia, 560052
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Chennai, Índia, 600086
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Cochin, Índia, 682026
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Mumbai, Índia, 400 067
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Pune, Índia, 411011
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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 at least 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, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
- 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 kilograms per square meter (kg/m2).
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 a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter [micromol/L]).
- Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [ALT], or aspartate transaminase [AST] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
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: Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
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Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
Outros nomes:
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Comparador Ativo: Detemir
Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.
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Patient specific dose administered subcutaneously once or twice daily 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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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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Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Prazo: Baseline, 12 Weeks, 24 Weeks
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Baseline, 12 Weeks, 24 Weeks
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Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
Prazo: 24 Weeks
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Percentage of patients achieving Hemaglobin A1c (HbA1c) targets of less than 7.0% and less than or equal to 6.5% at endpoint.
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24 Weeks
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Glycemic Variability
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) for the actual morning pre-meal blood glucose value.
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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 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 for All Study Periods
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.
Results are for the combined titration and maintenance periods.
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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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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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Number of Injections of Basal Insulin Analog at Endpoint
Prazo: 24 Weeks
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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
- 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.
- Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.x.
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 setembro de 2008
Conclusão do estudo (Real)
1 de setembro de 2008
Datas de inscrição no estudo
Enviado pela primeira vez
27 de junho de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de junho de 2007
Primeira postagem (Estimativa)
29 de junho de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
11 de novembro de 2009
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de novembro de 2009
Última verificação
1 de novembro de 2009
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 10935 (DAIDS-ES)
- F3Z-MC-IOOY
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