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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of D150, D745 and D759 Combination Therapy in Pateints With Type 2 Diabetes Inadequately Controlled With D150 Plus D759

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: D745 formulation I
* Drug: D745 formulation II
* Drug: D745 Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expermental group 1<br>Pateints assigned to this group are treated with D150, D759 and D745 formulation I | Drug: D745 formulation I<br>* QD for 24 weeks or 52 weeks(if extension study) with D150 and D759<br>|
| Experimental: Experimental group 2<br>Pateints assigned to this group are treated with D150, D759 and D745 formulation II | Drug: D745 formulation II<br>* QD for 24 weeks or 52 weeks(if extension study) with D150 and D759<br>|
| Placebo Comparator: Placebo group<br>Pateints assigned to this group are treated with D150, D759 and D745 placebo | Drug: D745 Placebo<br>* QD for 24 weeks or 52 weeks(if extension study) with D150 and D759<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | Baseline, 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | Baseline, 12 week | 
| Change from baseline in Fasting plasma glucose |  | Baseline, 12 week, 24 week |