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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide on Blood Pressure Control in Newly Diagnosed Type 2 Diabetes Individuals With Hypertension

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Drug: Perindopril and Amlodipine
* Drug: Perindopril-indapamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind head to head trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perindopril and Amlodipine<br>Fixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks | Drug: Perindopril and Amlodipine<br>* Fixed combination of Perindopril 5mg and Amlodipine 5mg<br>* Other names: Coveram5/5mg;|
| Active Comparator: Perindopril-Indapamide<br>Fixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks | Drug: Perindopril-indapamide<br>* Perindopril 5mg and Indapamide 1.25mg<br>* Other names: Bipreterax5/1.25;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour blood pressure | Change in average 24-hour blood pressure | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| night blood pressure dip | Change in average night time blood pressure drop | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, hypertension, blacks, Africa, ACE inhibitor, Calcium channel blocker, Diuretic