The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes

Chong Kun Dang

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: D745 formulation I; Drug: D745 formulation II; Drug: D745 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05566028

A127_02DM2210

Details and patient eligibility

About

The purpose of this study is to prove that the group treated with D745 in combination added that the reduction of HbA1c superior to placebo treated group added in combination.

Full description

The aim of this phase 3 study is to evaluate the efficacy and safety of additional combined D745 administration for 24 weeks in patient with type 2 diabetes who are no adequately controlled for blood glucose by the combination of D150 and D759

Enrollment: 165 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• between 19 years and 85 years old(male or female)
• Type 2 diabetes mellitus
• BMI between 18.5kg/m2 and 40kg/m2
• Agreement with written informed consent

Exclusion criteria

• Type 1 diabetes mellitus or secondary diabetes mellitus
• Patients with complications of severe diabetes such as proliferative diabetic retinopathy
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Patients with abnormal laboratory test results according to the protocol
• Continuous or non continuous treatment insulin within 12 weeks prior to screening
• Chronic oral or non oral corticosteroids treatment within 4 weeks prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 3 patient groups, including a placebo group

Expermental group 1

Experimental group

Description:

Pateints assigned to this group are treated with D150, D759 and D745 formulation I

Treatment:

Drug: D745 formulation I

Experimental group 2

Experimental group

Description:

Pateints assigned to this group are treated with D150, D759 and D745 formulation II

Treatment:

Drug: D745 formulation II

Placebo group

Placebo Comparator group

Description:

Pateints assigned to this group are treated with D150, D759 and D745 placebo

Treatment:

Drug: D745 Placebo