The Efficacy and Safety of CKD-501 Added to D150 Plus D759 Therapy in Patients With Type 2 Diabetes

Chong Kun Dang

Status and phase: Unknown; Phase 3

Conditions: Type2 Diabetes

Treatments: Drug: CKD-501 0.5mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03641352

19DM17012

Details and patient eligibility

About

The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.

Full description

The aim of this phase 3 study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patient with type 2 diabetes who were nao adequately controlled for blood glucose by the combination of D150 and D759

Enrollment: 240 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• between 19 years and 80 years old(male or female)
• Type 2 diabetes mellitus
• The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
• BMI between 21kg/m2 and 40kg/m2
• C-peptide ≥ 1.0 ng/ml
• Agreement with written informed consent
• HbA1c 7 to 10% after Run-in period

Exclusion criteria

• Type 1 diabetes mellitus or secondary diabetes mellitus
• Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
• Treatment with Thiazolidinedione(TZD) within 3 months or patient who has experience such as hypersensitivity reaction, serious adverse event with TZD, Biguanide
• Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
• Treatment with anti-obesity drugs within 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

CKD-501 0.5mg

Experimental group

Description:

CKD-501 0.5mg

Treatment:

Drug: CKD-501 0.5mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo