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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CKD-501 0.5mg

Group Type EXPERIMENTAL

CKD-501 0.5mg

Intervention Type DRUG

CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study to EOS(end of study).

Interventions

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CKD-501 0.5mg

CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759

Intervention Type DRUG

Placebo

Placebo, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study to EOS(end of study).

Intervention Type DRUG

Other Intervention Names

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Lobeglitazone

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No