Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Patrocinadores

Patrocinador principal: Dong-A ST Co., Ltd.

Fuente Dong-A ST Co., Ltd.
Resumen breve

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Estado general Not yet recruiting
Fecha de inicio November 14, 2019
Fecha de Terminación July 30, 2022
Fecha de finalización primaria July 30, 2022
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change from baseline in HbA1c (%) After 24 weeks 24 weeks
Resultado secundario
Medida Periodo de tiempo
Change from baseline in FPG(mg/dL) After 24 weeks 24 weeks
Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks 24 weeks
Change from baseline in 7-point SMBG After 24 weeks 24 weeks
Inscripción 276
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Evogliptin 5mg

Descripción: Participants receive Evogliptin 5mg orally once a day

Etiqueta de grupo de brazo: Evogliptin 5mg group

Otro nombre: Suganon

Tipo de intervención: Drug

Nombre de intervención: Evogliptin Placebo

Descripción: Participants receive placebo to match Evogliptin 5mg orally once a day

Etiqueta de grupo de brazo: Evogliptin Placebo group

Otro nombre: Placebo

Tipo de intervención: Drug

Nombre de intervención: Dapagliflozin 10mg

Descripción: Participants receive Dapagliflozin orally once a day

Otro nombre: Forxiga

Tipo de intervención: Drug

Nombre de intervención: Metformin ≥ 1000mg

Descripción: Metformin are administered at the same dose and formulation.

Elegibilidad

Criterios:

Inclusion Criteria:

- Patients with Type II diabetes mellitus aged 19 years or older

- Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy

1. Subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit

2. Subjects who are receiving metformin ≥ 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit

- Subjects with 7.0%≤HbA1c≤10.5% at screening visit

- Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit

- Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit

Exclusion Criteria:

- Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis

- patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia

- Patients with severe infectious disease or severe traumatic systemic disorders

- End stage renal disease or dialysis patients

- Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

- Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies

Género: All

Edad mínima: 19 Years

Edad máxima: N/A

Voluntarios Saludables: No

Contacto general

Apellido: Kun Ho Yoon

Teléfono: 82-2-2258-6007

Email: [email protected]

Ubicación
Instalaciones: Seoul St, Mary's Hospital,The Catholic University of Korea
Ubicacion Paises

Korea, Republic of

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Evogliptin 5mg group

Tipo: Experimental

Descripción: Evogliptin 5mg/d + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d

Etiqueta: Evogliptin Placebo group

Tipo: Placebo Comparator

Descripción: Evogliptin Placebo + Dapagliflozin 10mg/d + Metformin ≥ 1000mg/d

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov