Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide in Type 2 Diabetes

Yaounde Central Hospital

Status and phase: Completed; Phase 4

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Drug: Perindopril and Amlodipine; Drug: Perindopril-indapamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03747978

CNO20164

Details and patient eligibility

About

This was a double-blinded randomized controlled trial of 24-hour blood pressure control in sub Saharan type 2 diabetes patients, newly diagnosed for hypertension. They were allocated to receive either a fixed combination of perindopril + amlodipine or perindopril + indapamide for 42 days.

Full description

This was a double-blinded randomized controlled trial conducted at the National Obesity Center and the cardiology unit of the Yaoundé Central Hospital in Cameroon from October 2016 to May 2017. Eligible patients were type 2 diabetes patients, newly diagnosed for hypertension (grade I or II) with confirmation on ambulatory BP monitoring (ABPM). Patients were either on lifestyle modification alone or on a stable anti-diabetic treatment for the past three months, aged 25-65 years naïve to any anti-hypertensive treatment, who provided their written informed consent. Participants were assigned to receive as anti-hypertensive treatment perindopril-amlodipine once daily or perindopril-indapamide at the same frequency. The two groups were followed up and monitored for sixth weeks and patients did not take any additional treatment with BP modifying properties.

The primary outcome was the relative change in circadian blood pressure profile between the two groups after six weeks of treatment

Enrollment: 30 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult diabetes patients aged between 25-65 years,
• with grade I or grade II (WHO classification) hypertension on the clinical measure, confirmed by ABPM
• naïve to any anti-hypertensive treatment
• written informed consent.

Exclusion criteria

• Patients with grade III hypertension (WHO classification) were classified as hypertensive emergency,
• estimated creatinine clearance ˂30ml/min/1.73m2 (using Modified Diet in Renal Diseases formula)
• alanine transaminase (ALT)≥ 3 normal
• any contraindication to study drugs (hypersensitivity)
• pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Perindopril and Amlodipine

Experimental group

Description:

Fixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks

Treatment:

Drug: Perindopril and Amlodipine

Perindopril-Indapamide

Active Comparator group

Description:

Fixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks

Treatment:

Drug: Perindopril-indapamide