IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT01234597 (SeLan) para Diabetes mellitus, tipo 2 está concluído. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Voltar à pesquisa
SanofiEvaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day (SeLan) Fase IV 219
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT01234597 (SeLan) avaliou tratamento para Diabetes mellitus, tipo 2. Foi um estudo intervencionista de Fase IV. Seu status atual é: concluído. O estudo iniciou em 1 de dezembro de 2012 e incluiu 219 participantes. Coordenado por Sanofi e foi concluído em 1 de abril de 2015. Essas informações foram atualizadas no ClinicalTrials.gov em 13 de julho de 2016.
Resumo
Primary Objective:
To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen
Descrição detalhada
The study duration for each patient is 24 weeks +/- 1 week broken down as follows:
- Run-in phase: 8 weeks
- Follow - up Period: 16 weeks
The maximal possible time window during the study is +/- one week throughout the study.
Título oficial
A Comparative Study to Evaluate the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 DM Patients Uncontrolled With a Basal Insulin or Premix Once a Day
Condições médicas
Diabetes mellitus, tipo 2Outros IDs do estudo
- SeLan
- LANTU_L_05146
- U1111-1116-2926 (Outro identificador) (UTN)
Número NCT
Data de início (real)
2012-12
Última atualização postada
2016-07-13
Data de conclusão (estimada)
2015-04
Inscrição (estimada)
219
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Concluído
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Comparador ativoArm A: Without Continous Glucose Monitoring (CGM) sensor Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer .
Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician | INSULIN GLARGINE (HOE901) Pharmaceutical form: solution for injection Route of administration: subcutaneous INSULIN GLULISINE (HMR1964) Pharmaceutical form:Solution for injection Route of administration: Subcutaneous |
ExperimentalArm B: Continous Glucose Monitoring (CGM) sensor Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer .
Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the...Mostrar mais | INSULIN GLARGINE (HOE901) Pharmaceutical form: solution for injection Route of administration: subcutaneous INSULIN GLULISINE (HMR1964) Pharmaceutical form:Solution for injection Route of administration: Subcutaneous |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Changes in Hemoglobin A1c (HbA1c) level | Baseline, week 24 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Rate of hypoglycemia | Week 24 | |
Changes in insulin glargine dose | Baseline, week 24 | |
Changes in insulin glulisine dose | Baseline, week 24 |
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
21 Years
Sexos elegíveis
Todos
Run-in period:
- Type 2 diabetes
- HbA1c≥ 8.5% (in a test of the last month)
- Age above 21 years
- Patients continuously treated with basal insulin or mixed insulin once daily for the last 6 months
- Signed informed consent form
- Patients who according to their physician are eligible to the study
Randomization:
- HbA1c > 7.5%
- FPG < 130 mg/dl
- Type 1 diabetes
- Patients continuously treated with short-acting insulin or mixed insulin more than once daily for 3 weeks during the last 6 months.
- Pregnant or breastfeeding women.
- Patients with allergy to insulin.
- Patients with severe diseases characterized by recurrent hospitalizations, including: Severe renal insufficiency, severe cardiac insufficiency, active oncological disease or oncological disease requiring chemotherapy.
- Patients with mobility difficulties and/or difficulties communicating with the investigator
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
SanofiSem dados de contato.
11 Locais do estudo em 1 países
Investigational Site Number 376003, Beersheba, Israel
Investigational Site Number 376007, Haifa, Israel
Investigational Site Number 376004, Kfar Saba, 44281, Israel
Investigational Site Number 376012, Lod, Israel
Investigational Site Number 376013, Nazareth, Israel
Investigational Site Number 376006, Netanya, Israel
Investigational Site Number 376001, Ramat Gan, Israel
Investigational Site Number 376009, Sakhnin, Israel
Investigational Site Number 376008, Tel Aviv, Israel
Investigational Site Number 376010, Tel Aviv, Israel
Investigational Site Number 376011, Tel Aviv, Israel