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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Valsartan 80 mg and metformin; Drug: Metformin

• Registration Number: NCT04707508
• Lead Sponsor: Nantou Christian Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2019-01-23
• Study Completion: 2019-11-29
• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-13
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan and metformin	Valsartan 80 mg and metformin	-
Metformin only	Metformin	-

Primary Outcome Measures

Name	Time	Method
Serum glycosylated hemoglobin A1c	24 weeks	Change in serum glycosylated hemoglobin A1c of the participants

Secondary Outcome Measures

Name	Time	Method
Plasma lipid fractions	24 weeks	Change in plasma triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol
Blood pressure	24 weeks	Change in systolic blood pressure and diastolic blood pressure

Trial Locations

Locations (1)

Nantou Christian Hospital; 🇨🇳 Nantou City, Nantou County, Taiwan