Effects of Fimasartan on Insulin Secretion in Type 2 Diabetic Patients
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Mar 2015
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedApril 28, 2017
April 1, 2017
1.8 years
December 3, 2014
April 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Insulinogenic index
16 week
Secondary Outcomes (3)
HOMA β-cell function
16 week
Insulin resistance
16 week
Urinary albumin creatinine ratio, urinary protein creatinine ratio
16 week
Study Arms (2)
Fimasartan
EXPERIMENTALExpreimental drug is fimasartan.
Amlodipine
ACTIVE COMPARATORActive comparator is amlodipine.
Interventions
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover
16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-144, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
December 3, 2014
First Posted
December 9, 2014
Study Start
March 1, 2015
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
April 28, 2017
Record last verified: 2017-04