Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Irbesartan SR47436; Drug: Atorvastatin; Drug: Irbesartan/atorvastatin fixed dose combination

• Registration Number: NCT02842359
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To evaluate the effect of irbesartan/atorvastatin fixed-dose combination comparing to each irbesartan and atorvastatin on flow mediated dilation change in type 2 diabetic patients diagnosed with hyperlipidemia, hypertension.

Secondary Objective:

To evaluate efficacy of blood pressure and hyperlipidemic factors of irbesartan/atorvastatin fixed-dose combination in type 2 diabetic patients diagnosed with hyperlipidemia and hypertension, with adequately controlled blood glucose levels in groups.

Detailed Description

The total study duration per patient is up to maximum of 7 weeks.

Study Timeline

• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-22
• Study Start: 2016-08-23
• Primary Completion: 2018-04-19
• Study Completion: 2018-04-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irbesartan	Irbesartan SR47436	Irbesartan will be given orally daily for 28 days
Atorvastatin	Atorvastatin	Atorvastatin will be given orally daily for 28 days
Rovelito	Irbesartan/atorvastatin fixed dose combination	Fixed-dose combination of irbesartan/atorvastatin will be given orally daily for 28 days

Primary Outcome Measures

Name	Time	Method
Change from baseline in flow mediated dilatation	4 weeks, up to maximum 5 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of change from baseline in Intercellular Adhesion Molecule-1	4 weeks, up to maximum 5 weeks
Rate of change from baseline in nytrotyrosine marker	4 weeks, up to maximum 5 weeks
Rate of change from baseline in Interleukin-6	4 weeks, up to maximum 5 weeks
Rate of change from baseline in C-reactive protein	4 weeks, up to maximum 5 weeks
Change from baseline in blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group)	4 weeks, up to maximum 5 weeks
Change from baseline in low density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)	4 weeks, up to maximum 5 weeks
Change from baseline in total cholesterol (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)	4 weeks, up to maximum 5 weeks
Change from baseline in high density lipoprotein-C (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)	4 weeks, up to maximum 5 weeks
Change from baseline in triglycerides (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)	4 weeks, up to maximum 5 weeks
Change from baseline in apolipoprotein-A1 (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group)	4 weeks, up to maximum 5 weeks
Change from baseline in apolipoprotein-B (irbesartan/atorvastatin fixed-dose combination group and atorvastatin group) - Time Frame: 4 weeks, up to maximum 5 weeks	4 weeks, up to maximum 5 weeks
Percentage of participants with decreased level of blood pressure (irbesartan/atorvastatin fixed-dose combination group and irbesartan group)	4 weeks, up to maximum 5 weeks
Rate of change from baseline in immunosenescence T cell fractionation	4 weeks, up to maximum 5 weeks
Rate of change from baseline in T-cell induced inflammatory factors	4 weeks, up to maximum 5 weeks

Trial Locations

Locations (1)

Korea; 🇰🇷 Seoul, Korea, Republic of