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Effects of Fimasartan on Insulin Secretion in Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02312375
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Hye Seung Jung, Seoul National University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hypertension Drug: Fimasartan Drug: Amlodipine Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Fimasartan on Insulin Secretion, and Interaction With DPP4 Inhibitors in Patients With Type 2 Diabetes
Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fimasartan
Expreimental drug is fimasartan.
Drug: Fimasartan
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover

Active Comparator: Amlodipine
Active comparator is amlodipine.
Drug: Amlodipine
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover




Primary Outcome Measures :
  1. Insulinogenic index [ Time Frame: 16 week ]

Secondary Outcome Measures :
  1. HOMA β-cell function [ Time Frame: 16 week ]
  2. Insulin resistance [ Time Frame: 16 week ]
  3. Urinary albumin creatinine ratio, urinary protein creatinine ratio [ Time Frame: 16 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312375


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-144
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Hye Seung Jung, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02312375    
Other Study ID Numbers: Fimasartan study
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents