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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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This study evaluate the efficacy and safety of alogliptin and pioglitazone combination therapy in comparison with either alogliptin or pioglitazone on glucose control in the metformin-treated type 2 diabetic patients in Korea.
Pathophysiology of type 2 diabetes is known as insulin resistance and progressive beta cell dysfunction.
Combination therapy with biguanides, glucagon-like peptide-1(GLP-1) agonists or dipeptidyl peptidase-4 inhibitor(DPP4I) and thiazolidinediones(TZD) seems reasonable theoretically, for their effects on different pathophysiologic defects.
Current treatment guidelines recommend a stepwise approach starting with lifestyle modification or lifestyle modification + metformin monotherapy, with recent focusing on patient individualization.
In Korea, Korean Diabetes Association also recommends stepwise approach and at the same time, emphasizes on the initial aggressive treatment including oral combination or insulin therapy according to HbA1c level to achieve target goal <6.5%.
Guide to the efficacy, timing, options of combination therapy is not clearly defined due to lack of sufficient evidences yet.
There is no clear report to demonstrate the clinical benefit of initial TZD and DPP4I combination therapy in the Korean.
Thus it is reasonable to study the effect of combination therapy in the patients with sub-optimal glucose control with metformin therapy only, comparing various combination options metformin with DPP4I only, TZD only, or both.
The hypothesis of this study is that combination therapy of alogliptin and pioglitazone added on the metformin has superior effect on HbA1c reduction than metformin and either alogliptin or pioglitazone in 6 month treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alogliptin + pioglitazone | Experimental | alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll |
|
| alogliptin | Active Comparator | alogliptin 25 mg 1 tablet daily for 24 weeks pioglitazone matching placebo 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll |
|
| Pioglitazone | Active Comparator | alogliptin matching placebo 1 tablet daily for 24 weeks pioglitazone 30 mg 1 tablet daily for 24 weeks metformin for 24 weeks as the same dose and frequency as before enroll |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alogliptin | Drug | alogliptin 25 mg add-on background medication metformin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycohemoglobin(HbA1c) from baseline | baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving HbA1c < 7.0% | 24 week | |
| Proportion of subjects achieving HbA1c <6.5% | 24 week | |
| Changes in glycated albumin(GA) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kun-Ho Yoon, MD, PhD | Seoul St Mary's Hospital, The Catholic Univerisity of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St Mary's Hospital, The Catholic University of Korea | Seoul | 137-701 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C520853 | alogliptin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Pioglitazone | Drug | pioglitazone 30 mg add-on background medication metformin |
|
|
| alogliptin + pioglitazone | Drug | alogliptin 25 mg and pioglitazone 30 mg add-on background medication metformin |
|
|
| baseline, 24 weeks |
| Change in GA/HbA1c ratio from baseline | baseline, 24 weeks |
| Change in fasting blood sugar from baseline | baseline, 24 weeks |
| Incidence of hyperglycemic rescue | at Week 12, HbA1c >9.0% | 12 week |
| Change in HbA1c from baseline | 12 week |
| Change in total cholesterol from baseline | baseline, 24 weeks |
| Change in triglycerides from baseline | baseline, 24 weeks |
| Change in LDL-cholesterol from baseline | baseline, 24 weeks |
| Change in HDL-cholesterol from baseline | baseline, 24 weeks |
| Changes in glycated albumin(GA) from baseline | baseline, 12 weeks |
| Change in GA/HbA1c ratio from baseline | baseline, 12 weeks |
| Change in fasting blood sugar from baseline | baseline, 12 weeks |
| Change in total cholesterol from baseline | baseline, 12 weeks |
| Change in triglycerides from baseline | baseline, 12 weeks |
| Change in LDL-cholesterol from baseline | baseline, 12 weeks |
| Change in HDL-cholesterol from baseline | baseline, 12 weeks |
| Change in Homeostasis Model Assessment-Insulin resistance(HOMA-IR) from baseline | a marker of insulin resistance | baseline, 24 weeks |
| Change in Homeostasis Model Assessment - beta cell (HOMA-beta) from baseline | a marker of beta cell function | baseline, 24 weeks |
| Change in highly sensitive C reactive protein(hs-CRP) from baseline | a marker of inflammation | baseline, 24 weeks |
| Change in Plasmonogen activator inhibitor-1(PAI-1) from baseline | baseline, 24 weeks |
| Change in B-type natriuretic pepetide(BNP) from baseline | baseline, 24 weeks |
| event rate of hypoglycemia | A number of total event of hypoglycemia defined as blood glucose <70mg/dL or subjective symptom of typical hypoglycemia | upto 24 weeks |
| No of subject with adverse event of special interest | The event of special interest include
| upto 24 weeks |
| The number of serious adverse events | upto 24 weeks |
| The number of subject with hypersensitivity to study drugs | upto 24 weeks |
| The number of subject with any abnormality of laboratory evaluation |
| 12 week |
| The number of subject with any abnormality of laboratory evaluation |
| 24 week |
| The number of subject with any change of findings in Chest X-ray from baseline | 24 week |
| The number of subject with any change of findings in electrocardiogram from baseline | 24 week |
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |