Investigating the Effect of Renin-Angiotensin System Inhibitors in Addition to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Mellitus: A Prospective Open-label Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Nantou Christian Hospital
- Enrollment
- 203
- Locations
- 1
- Primary Endpoint
- Serum glycosylated hemoglobin A1c
Study Overview
Brief Summary
Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. The renin-angiotensin system (RAS) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. This study investigates the effect of adding RAS inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment. Secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adults over 21 years of age
- •clinically diagnosed type 2 diabetes mellitus
- •recipients of metformin monotherapy
- •compliance with prescriptions and dietary intervention
Exclusion Criteria
- •recipients of any second-line antidiabetic drug in addition to metformin
- •recipients of any antihypertensive medication before study enrollment
- •hemoglobin disorders
- •chronic kidney disease
- •thyroid dysfunction
Arms & Interventions
Valsartan and metformin
Intervention: Valsartan 80 mg and metformin (Drug)
Metformin only
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
Serum glycosylated hemoglobin A1c
Time Frame: 24 weeks
Change in serum glycosylated hemoglobin A1c of the participants
Secondary Outcomes
- Plasma lipid fractions(24 weeks)
- Blood pressure(24 weeks)
Investigators
Po-Chung Cheng
Director, Division of endocrine and metabolic diseases
Nantou Christian Hospital