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The research subjects selected for this trial will patients among those who have given their approval to participate in the trial and who are first starting their treatment or who intend to alter their medication because treatment with the existing drugs has failed who satisfy the criteria.
Patients with a '7.5% ≤ HbA1c ≤ 10%' in the HbA1c test will be chosen.
Patients who are intending to change drugs due to the failure of an existing drug treatment must have the use of 1,000 mg or the maximum tolerance dose (MTD) of metformin recorded in his or her medical records.
The investigators must confirm the patient's intention to participate in the trial and, starting at the point of the routine laboratory test results, must provide a sufficient explanation of this research to the patients who satisfy the criteria and then must acquire a research subject consent form from these patients. The consent forms must include the trial objectives, the benefits for participants, the risk factors, a confidentiality agreement, the right to withdraw consent, and contact information. The patients must sign the consent forms.
Week 4 Week 12 Alogliptin 25mg Dosage adjustment is not allowed Dosage adjustment is not allowed Glimepiride1mg 2mg Dosage adjustment is not allowed Alogliptin 25mg
+Pioglitazone 15mg Dosage adjustment is not allowed Dosage adjustment is not allowed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glimepiride | Active Comparator | glimepiride 1mg monotherapy and glimepiride 2mg monotherapy |
|
| alogliptin | Active Comparator | alogliptin 25mg monotherapy |
|
| alogliptin - pioglitazone | Active Comparator | Alogliptin 25mg+pioglitazone 15mg combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glimepiride | Drug |
| ||
| Alogliptin 25Mg Tab |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | The change in the mean level of HbA1c from baseline at week 24 | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c and fasting plasma glucose | The change in the mean level of HbA1c at week 12 and mean FPG( fasting plasma glucose) levels | Baseline, Week 12, Week 24 |
| The change in parameters of glycemic variability assessed by CGM from the Baseline at week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Additional criteria for exclusion are listed below;
Criteria for exclusion based on laboratory test results are as listed below.
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| Name | Affiliation | Role |
|---|---|---|
| Sung Hee Choi | Seoul National University Hospital | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 29, 2016 | Jul 10, 2020 | Prot_000.pdf |
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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 |
|---|---|
| C057619 | glimepiride |
| C520853 | alogliptin |
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Group A (glimepiride), Group B (alogliptin), and Group C (alogliptin-pioglitazone)
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|
| Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet | Drug |
|
The change in parameters of glycemic variability assessed by CGM from baseline at week 24: SD(standard deviation), MAGE(Mean Amplitude of Glycaemic Excursions); MODD(Mean of Daily Differences); ADDR(Average Daily Risk Range), M-value
| Baseline, Week 24 |
| The change in lipid profile from baseline at week 12 and 24 | The average change in the lipid profile: Total cholesterol (mg/dL), Triglyceride(mg/dL), HDL-cholesterol, (mg/dL) LDL cholesterol (mg/dL) | Baseline, Week 12, Week 24 |
| D004700 | Endocrine System Diseases |