Effects of Fimasartan on Insulin Secretion in Type 2 Diabetic Patients

Hypertension Clinical Trial

Official title:

Effects of Fimasartan on Insulin Secretion, and Interaction With DPP4 Inhibitors in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312375
• Other study ID #: Fimasartan study
• Status: Completed
• Phase: N/A
• First received: December 3, 2014
• Last updated: April 27, 2017
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Intervention

Drug:
• Fimasartan
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover
• Amlodipine
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulinogenic index		16 week
Secondary	HOMA ß-cell function		16 week
Secondary	Insulin resistance		16 week
Secondary	Urinary albumin creatinine ratio, urinary protein creatinine ratio		16 week