Diabetes MellitusNCT02312375
Effects of Fimasartan on Insulin Secretion in Type 2 Diabetic Patients
A study testing Fimasartan and Amlodipine in people with Diabetes Mellitus and Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- What is being tested?
- Fimasartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fimasartan on Insulin Secretion, and Interaction With DPP4 Inhibitors in Patients With Type 2 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hypertension
- Being tested
- Fimasartan, Amlodipine
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover
AmlodipineDrug
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover
| Study group | Role | What they receive |
|---|---|---|
| Fimasartan | Experimental | Expreimental drug is fimasartan. Receives: Drug: Fimasartan |
| Amlodipine | Active comparator | Active comparator is amlodipine. Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulinogenic index
Measured: 16 week
Secondary outcomes (3)
HOMA β-cell function
Measured: 16 week
Insulin resistance
Measured: 16 week
Urinary albumin creatinine ratio, urinary protein creatinine ratio
Measured: 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye Seung Jung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312375
- Sponsor's protocol ID
- Fimasartan study
- Status last verified
- Apr 2017
- First submitted
- 3 Dec 2014
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fimasartan on Insulin Secretion, and Interaction With DPP4 Inhibitors in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02312375
- Acronym / sponsor ID
- Fimasartan study
- Conditions
- Diabetes Mellitus, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fimasartan | Experimental | Drug: FimasartanExpreimental drug is fimasartan. |
| Amlodipine | Active comparator | Drug: AmlodipineActive comparator is amlodipine. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fimasartan16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover | Drug | Fimasartan |
| Amlodipine16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover | Drug | Amlodipine |
Primary outcome
Insulinogenic index
Time frame: 16 week
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fimasartan and Amlodipine in people with Diabetes Mellitus and Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulinogenic index (time frame: 16 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.