A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus (CLASSIC)
6 de março de 2020 atualizado por: Eli Lilly and Company
Comparison Between Basal Insulin Analog and Insulin Analog Mid Mixture AS Starter Insulin for Chinese Patients With Type 2 Diabetes Mellitus (CLASSIC Study)
The purpose of this study is to compare the effectiveness of basal insulin analog and insulin analog mid mixture in Chinese participants with type 2 diabetes mellitus.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
814
Estágio
- Fase 4
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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Beijing, China, 102206
- Peking University International Hospital
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Beijing, China
- Beijing Hai Dian Hospital
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Shanghai, China, 200090
- Shanghai Yangpu District Central Hospital
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Beijing
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Beijing, Beijing, China, 100044
- Peking University Peoples Hospital
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Beijing, Beijing, China, 100016
- Beijing Huaxin Hospital
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Chaoyang, Beijing, China, 100028
- China Meitan General Hospital
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Fangshan, Beijing, China, 102500
- Beijing Yanhua Hospital
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Gansu
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Lanzhou, Gansu, China, 730030
- The 2nd Hospital of Lanzhou University
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Guangdong
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Shenzhen, Guangdong, China, 518020
- Shenzhen City People Hospital
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Yuexiu, Guangdong, China, 510080
- The 1st Hospital with Guangdong Pharmaceutical University
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Henan
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Luoyang, Henan, China, 471003
- The 1st Affiliated Hospital of Henan Science and technology
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Zhengzhou, Henan, China, 450003
- People's Hospital of Henan Province
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Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Union (Xiehe) Hospital
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Jiangsu
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Changzhou, Jiangsu, China, 213003
- Changzhou No.2 People's Hospital
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Nanjing, Jiangsu, China, 210001
- Nanjing TCM hospital
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Nanjing, Jiangsu, China, 210024
- Jiang Su Province Official Hospital
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Nanjing, Jiangsu, China, 210048
- Nanjing Jiangbei Hospital
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Nanjing, Jiangsu, China, 211100
- Nanjing Jiangning Hospital
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Taizhou, Jiangsu, China, 225300
- Taizhou City People Hospital
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Wuxi, Jiangsu, China, 214000
- The Second People's Hospital of Wuxi
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Xuzhou, Jiangsu, China, 221009
- Xuzhou Central Hospital
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Shandong
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Qingdao, Shandong, China, 266071
- Qingdao Municipal Hospital
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Taian, Shandong, China, 271000
- Taian City Central Hospital
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Shanghai
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Shanghai, Shanghai, China, 200135
- Shanghai Pudong New Area Gongli Hospital
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Shanghai, Shanghai, China, 201318
- Shanghai Pudong New District Zhoupu Hospital
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Shunqing
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Nanchong, Shunqing, China, 637000
- Affiliated Hospital of North Sichuan Medical College
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Sichuan
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Chengdu, Sichuan, China, 610041
- The Third Affiliated Hospital of Chengdu University of TCM
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Luzhou, Sichuan, China, 646000
- Southwest Medical University Affiliated Hospital
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Tianjin
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Nankai, Tianjin, China, 300192
- Tianjin First Central Hospital
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Tongzhou
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Beijing, Tongzhou, China, 101149
- Beijing Luhe Hospital Capital Medical University
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Zhejiang
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Hangzhou, Zhejiang, China, 310014
- Zhejiang Provincial People's Hospital
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Ningbo, Zhejiang, China, 315010
- Ningbo First Hospital
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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 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- have type 2 diabetes as defined by World Health Organization (WHO) criteria
- are taking oral anti-hyperglycemic medications (OAMs) and are judged as OAM failure by the investigator
- most recent HbA1c value ≥7.5% within 12 weeks of study entry
- in the opinion of the investigator, require to initiate premix analog or basal insulin analog treatment
- willing to start with insulin treatment
Exclusion Criteria:
- have a diagnosis of type 1 diabetes
- have received any type of insulin within 24 months of study entry (except for intermittent use of insulin of less than 1 month each time)
- have serious preexisting medical or other conditions that, in the judgment of the investigator, would preclude participation in this study
- are pregnant or breastfeeding, or intend to become pregnant during the course of the study
- are currently enrolled or have participated, within the last 30 days in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible
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 Analog Mid Mixture
Insulin analog mid mixture given subcutaneously (SC).
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Administered SC
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Experimental: Basal Insulin Analog
Basal insulin analog given SC.
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Administered SC
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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 to Week 24 in Hemoglobin A1c (HbA1c)
Prazo: Baseline, 24 Weeks
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HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate. |
Baseline, 24 Weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline to Week 48 in HbA1c
Prazo: Baseline, 48 Weeks
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HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate. |
Baseline, 48 Weeks
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Percentage of Participants Who Achieve HbA1c <7% at Week 24
Prazo: 24 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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24 Weeks
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Percentage of Participants Who Achieve HbA1c <7% at Week 48
Prazo: 48 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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48 Weeks
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Change From Baseline to Week 24 in Venous Fasting Plasma Glucose
Prazo: Baseline, 24 Weeks
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Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast.
Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Venous Fasting Plasma Glucose
Prazo: Baseline, 48 Weeks
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Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast.
Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.
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Baseline, 48 Weeks
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Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Prazo: Baseline, 24 Weeks
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Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG.
LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose
Prazo: Baseline, 48 Weeks
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Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG.
LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.
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Baseline, 48 Weeks
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Total Daily Insulin Dose at Week 24 and 48
Prazo: 24 Weeks, 48 Weeks
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Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.
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24 Weeks, 48 Weeks
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Change From Baseline to Week 24 in Body Weight
Prazo: Baseline, 24 Weeks
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LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
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Baseline, 24 Weeks
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Change From Baseline to Week 48 in Body Weight
Prazo: Baseline, 48 Weeks
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LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.
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Baseline, 48 Weeks
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Rate of Hypoglycemia at Week 24 and 48
Prazo: 24 Weeks, 48 Weeks
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Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L).
The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25)
as an offset variable.
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24 Weeks, 48 Weeks
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Number of Participants With Insulin Treatment Change at Week 48
Prazo: Baseline through 48 Weeks
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Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.
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Baseline through 48 Weeks
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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24
Prazo: 24 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
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24 Weeks
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Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48
Prazo: 48 Weeks
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Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.
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48 Weeks
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Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score
Prazo: Baseline, 48 Weeks
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The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy.
The SEITQ consists of 5 items (that is, statements).
The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications.
Each item score ranges from 1 (strongly disagree) to 7 (strongly agree).
The total SEITQ score is the sum of each item scores, with the range of 5 to 35.
Higher SEITQ score indicates better outcome (higher self-efficacy).
LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.
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Baseline, 48 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
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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 (Real)
6 de fevereiro de 2017
Conclusão Primária (Real)
19 de fevereiro de 2019
Conclusão do estudo (Real)
12 de julho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
11 de janeiro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de janeiro de 2017
Primeira postagem (Estimativa)
12 de janeiro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de março de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de março de 2020
Última verificação
15 de agosto de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 16507
- F3Z-GH-IOQR (Outro identificador: Eli Lilly and Company)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Prazo de Compartilhamento de IPD
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
Critérios de acesso de compartilhamento IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .