Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus

Nantou Christian Hospital

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin; Drug: Valsartan 80 mg and metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04707508

Y_106_0298

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 2 patient groups

Valsartan and metformin

Experimental group

Treatment:

Drug: Valsartan 80 mg and metformin

Metformin only

Active Comparator group

Treatment:

Drug: Metformin