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O estudo clínico NCT07433062 (IRAK4) para Diabetes mellitus tipo 2 está em recrutamento. 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. | ||
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AstraZenecaA Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus (IRAK4) Fase I 28
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 NCT07433062 (IRAK4) procura avaliar outros para Diabetes mellitus tipo 2. Este é um estudo intervencionista de Fase I. Seu status atual é: em recrutamento. O estudo começou em 14 de janeiro de 2026 e pretende incluir 28 participantes. Coordenado por AstraZeneca e deve ser concluído em 18 de junho de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de fevereiro de 2026.
Resumo
The purpose of this study is to examine the effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus.
Descrição detalhada
This is a double-blind, placebo-controlled, 2-period cross-over study conducted at a single study centre to assess the pharmacokinetics and pharmacodynamics (ie, glucose lowering effect) of metformin in participants with T2DM when metformin is administered alone and in combination with multiple doses of AZD6793. This study will consist of 2 treatment periods separated by a washout period of 7 to 14 days.
Approximate...
Mostrar maisTítulo oficial
A Double-blind, Placebo-controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Effect of Steady-state AZD6793 on the Steady-state Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus
Condições médicas
Diabetes mellitus tipo 2Outros IDs do estudo
- IRAK4
- D7860C00005
Número NCT
Data de início (real)
2026-01-14
Última atualização postada
2026-02-25
Data de conclusão (estimada)
2026-06-18
Inscrição (estimada)
28
Tipo de estudo
Intervencionista
FASE
Fase I
Status
Em recrutamento
Palavras-chave
Diabetes
T2DM
T2DM
Propósito principal
Outro
Alocação do design
Randomizado
Modelo de intervenção
Estudo cruzado
Cegamento (Mascaramento)
Triplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalTreatment A AZD6793 and metformin | AZD6793 Participants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 (Treatment A). |
ExperimentalTreatment B Placebo and metformin | AZD6793 Placebo Participants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 placebo (Treatment B). |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Mean glucose levels | Mean glucose levels on Day 7 of each treatment period as assessed by Continuous Glucose Monitoring (CGM) | Day 7 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
CGM Metric (Time in range) | The percentage of time (or hours/day) that blood glucose levels remain within a target | Day 7 of each treatment period |
CGM Metric (Time in tight range) | A metric measuring the percentage of time blood glucose remains between a pre-defined range. | Day 7 of each treatment period |
CGM Metric (time below range) | A metric representing the percentage of time and minutes per day spent with blood glucose below a certain range. | Day 7 of each treatment period |
CGM Metric (time above range) | A metric representing the percentage of time and minutes per day spent with blood glucose above a certain range. | Day 7 of each treatment period |
CGM Metric (AUC(0-24)) | area under the concentration-time curve from time 0 to 24 hours postdose | Day 7 of each treatment period |
CGM Measure (Plasma fasting glucose) | A measure of glucose levels when a participant is in a fasting state. | Day 7 of each treatment period |
CGM Measure (AUC(0-4) after each meal) | area under the concentration-time curve from time 0 to 4 hours postdose after each meal | Day 7 of each treatment period |
CGM Measure (Total glucose AUC(0-24)) | area under the concentration-time curve from time 0 to 24 hours postdose | Day 7 of each treatment period |
Metformin Plasma PK (AUC(0-12)) | area under the concentration-time curve from time 0 to 12 hours postdose | Day 7 of each treatment period |
Metformin Plasma PK (Cmax) | maximum observed concentration | Day 7 of each treatment period |
Metformin Plasma PK (tmax) | time to reach maximum observed plasma concentration | Day 7 of each treatment period |
Metformin Plasma PK (t1/2λz) | Terminal elimination half-life | Day 7 of each treatment period |
Metformin Plasma PK (CL/F) | apparent total body clearance | Day 7 of each treatment period |
Metformin Plasma PK (Vz/F) | apparent volume of distribution during the terminal phase. | Day 7 of each treatment period |
Metformin Plasma PK (R AUC(0-12)) | Ratio of test to reference based on AUC(0-12) | Day 7 of each treatment period |
Metformin Plasma PK (R Cmax) | Ratio of test to reference based on Cmax | Day 7 of each treatment period |
Metformin Urine PK (Ae(0-12)) | cumulative amount excreted into the urine from time 0 to 12 hours postdose | Day 7 of each treatment period |
Metformin Urine PK (fe(0-12)) | Percentage of dose excreted unchanged in urine from time zero to 12 hours post-dose | Day 7 of each treatment period |
Metformin Urine PK (CLR) | renal clearance from plasma | Day 7 of each treatment period |
AZD6793 plasma PK (AUC(0-24)) | area under the concentration-time curve from time 0 to 24 hours postdose | Days 1 through 7 of each treatment period |
AZD6793 plasma PK (Cmax) | maximum observed concentration | Days 1 through 7 of each treatment period |
AZD6793 plasma PK (tmax) | time to reach maximum observed plasma concentration | Days 1 through 7 of each treatment period |
AZD6793 plasma PK (t1/2λz) | Terminal elimination half-life | Days 1 through 7 of each treatment period |
AZD6793 plasma PK (Ctrough) | concentration observed immediately prior to dosing | Days 1 through 7 of each treatment period |
AZD6793 plasma PK (Rac AUC(0-24)) | accumulation ratio based on AUC(0-24) | Days 1 through 7 of each treatment period |
AZD6793 plasma PK (Rac Cmax) | Accumulation ration based on Cmax | Days 1 through 7 of each treatment period |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
- Physician-diagnosis of T2DM
- On a stable dose of metformin 2000 mg per day for at least 3 months prior to screening.
- stable glycaemic control indicated by no change in treatment for diabetes within 3 months prior to screening
- HbA1c (Hemoglobin A1c) ≤ 8.5% at screening
- Body Mass Index (BMI) within the range 18.5 to 35 kg/m2 , inclusive, at screening.
- Physician diagnosis of type 1 diabetes.
- History of any clinically important disease or disorder.
- History or presence of chronic Gastrointestinal, hepatic, renal, or pancreatic disease
- History of Human immunodeficiency viruses (HIV) infection or a positive HIV test.
- History of prior episode(s) of lactic acidosis.
AstraZenecaContato central do estudo
Contato: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
1 Locais do estudo em 1 países
Research Site, Neuss, 41460, Germany
Em recrutamento