This trial is active, not recruiting.

Conditions diabetes mellitus, hypertension
Treatments fimasartan, amlodipine
Sponsor Seoul National University Hospital
Start date March 2015
End date December 2016
Trial size 46 participants
Trial identifier NCT02312375, Fimasartan study


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Expreimental drug is fimasartan.
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover
(Active Comparator)
Active comparator is amlodipine.
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover

Primary Outcomes

Insulinogenic index
time frame: 16 week

Secondary Outcomes

HOMA β-cell function
time frame: 16 week
Insulin resistance
time frame: 16 week
Urinary albumin creatinine ratio, urinary protein creatinine ratio
time frame: 16 week

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: - Aged 20~80 years - Type 2 diabetic patients diagnosed more than 6 months ago - HbA1c ≤8.5% at screening - No change of OAD within the 3 months before screening - SBP <140 mmHg and DBP <90 mmHg with anti-hypertensive drug at screening - SBP ≥140 mmHg or DBP ≥80 mmHg without anti-hypertensive drug at screening Exclusion Criteria: - Type 1 diabetic patients or active insulin treatment at screening - Treatment with ARB or ACEi within 1 month prior to screening - Uncontrolled hypertension with SBP >170 mmHg or DBP >100 mmHg - Pregnancy or lactation - Elevated liver enzyme (AST or ALT > 3 times the UNL) or elevated serum Cr (≥1.5 mg/dL in men and 1.4 mg/dL in women)

Additional Information

Official title Effects of Fimasartan on Insulin Secretion, and Interaction With DPP4 Inhibitors in Patients With Type 2 Diabetes
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.