Evaluation of Losartan and Perindopril in Blacks Type 2 Diabetics Patients (CARE-PLP)

Yaounde Central Hospital

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Losartan Potassium; Drug: Perindopril Arginine

Study type: Interventional

Funder types: Other

Identifiers

NCT04222686

CARE-PLP

Details and patient eligibility

About

The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.

Full description

Given the particularity of the renin-angiotensin system in black subjects, the CARE-PLP study fulfills this objective with the comparison of Losartan and Perindopril after 08 weeks of administration in a subsaharan African population.

Aim: The aim of this study is to compare the short-term effects of ACEi and angiotensin II receptor blockers on cardiac and renal protection in black type 2 diabetics patients

Methods: CARE-PLP is a double-arm, double-blind, randomized and parallel clinical trial conducted at the National Obesity Center in the Yaoundé Central Hospital. A population of Type 2 diabetes patients, with hypertension and / or microalbuminuria and who are not taking ACEi or angiotensin receptors blockers, is randomize into two groups. Depending on the group, 10 mg Perindopril or 100 mg Losartan is add to the usual treatment for each patient. The patients are followed-up for a period of 08 weeks. The primary outcome is the variation of exercise induced urinary albumin excretion after 08 weeks of intervention.

Progress: Recruitment for CARE-PLP was completed in february 2018 with 29 patients.

Enrollment: 23 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetics subjects
• Urinary albumin excretion >30 g/day or Blood pressure > 140/90
• On a stable antidiabetic and antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes. The pharmacological treatment should not include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker
• Subject must not present any contraindication to exercise
• Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion criteria

• Side effects affecting life quality of patients (determined by the Data Safety Monitoring Board).
• Signs of exercise intolerance
• Out of sight.
• Withdrawal of consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

23 participants in 2 patient groups

Perindopril Arm

Active Comparator group

Description:

10 mg Perindopril tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.

Treatment:

Drug: Perindopril Arginine

Losartan Arm

Active Comparator group

Description:

100 mg Losartan tablet per day at 8am (+/- 1 hour) was add to the usual treatment for each patient. Patients are followed-up for a period of 08 weeks.

Treatment:

Drug: Losartan Potassium