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This study was designed to evaluate the effect of ARB in improving insulin secretion in patients with type 2 diabetes. The investigators also aimed to evaluate if there are potential synergisms between ARB and DPP4 inhibitors in improving insulin secretion and urinary albumin secretion in diabetic patients.
Angiotensin II has been reported to insulin secretion in beta cells. Angiotensin II indirectly improves insulin secretion in beta cells via vasoconstriction and reduced islet blood flow. Chronic exposure to high glucose or high fat increases expression of AT1R (angiotensin type 1 receptor), leading to reactive oxidative stresses, inflammation, and apoptosis in beta cells, finally decreased insulin formation and secretion. Some studies showed the beneficial effect of blocking AT1R on insulin secretion and beta cell proliferation in animal models using angiotensin receptor blocker (ARB). Furthermore, 26 weeks of valsartan treatment improved insulin secretion in humans with impaired glucose regulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan | Experimental | Expreimental drug is fimasartan. |
|
| Amlodipine | Active Comparator | Active comparator is amlodipine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan | Drug | 16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulinogenic index | 16 week |
| Measure | Description | Time Frame |
|---|---|---|
| HOMA β-cell function | 16 week | |
| Insulin resistance | 16 week | |
| Urinary albumin creatinine ratio, urinary protein creatinine ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-144 | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Amlodipine | Drug | 16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover |
|
| 16 week |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |