Diabetes mellitus and hypertension are among the most common diseases and cardiovascular risk factors, respectively, worldwide, and their frequency increases with increasing age. Elevated blood pressure (BP) values are a common finding in patients with type 2 diabetes mellitus (T2D) and are thought to reflect, at least in part, the impact of the underlying insulin resistance on the vasculature and kidney.

Epidemiology: The prevalence of diabetes and hypertension in India is high across all geographical settings and socioeconomic groups in middle and old age, according to a study published in JAMA International. The number of people with diabetes in India increased from 26 million in 1990 to 65 million in 2016. An Indian study published in JAPI mentioned that the prevalence of hypertension – Stage II among people with diabetes in India was reported to be ~44.8% and obesity and overweight was significantly associated with the prevalence of hypertension in diabetics. Another study by Shashank et al. reported the existence of hypertension to be as high as 59.3% in diabetic patients.

The development of hypertension in diabetic individuals not only complicates treatment strategy and increases healthcare costs but also heightens the risk for macrovascular and microvascular complications considerably. Although BP lowering is followed by a significant reduction in cardiovascular and microvascular morbidity and mortality, a large proportion of diabetic patients exhibit poorly controlled hypertension.

In this population, hypertension increases risk for kidney disease onset and progression and cardiovascular (CV) morbidity and mortality. Diabetic nephropathy is the most common cause of CKD in those with diabetes and is one of the leading attributable cause for incident end stage renal disease (ESRD). There is evidence that blood pressure reduction has been associated with a decreased risk of diabetes related complications.

As per guideline recommendations, the recommended treatment regime to begin with is an SPC of 2 antihypertensive drugs. There is not much published literature especially in the Indian diabetic hypertensive population for the choice of treatment and early interventions to manage hypertension and retard the progression of kidney disease.

Cilnidipine is a novel and promising CCB developed for the management of hypertension, possesses both L and N type calcium channel blocking activity. It is well known among physicians for its unique sympatholytic action and a major advantage of reno-protection (reduction in proteinuria, podocyte protection, reduction in glomerular pressure), thus revolutionizing the treatment of hypertension with an added advantage of end organ protection.

Cilnidipine also has shown to improve insulin sensitivity in patients of essential hypertension possibly due to its vasodilatory action without stimulating sympathetic nervous activity.

Backed by multiple studies and mega trials (mostly in the Japanese population), the molecule has been concluded to be a highly effective anti-hypertensive along with its cardio-protective, reno-protective and neuro-protective benefits.

Telmisartan is a well-known ARB, with a long half-life of 24-hours. The molecule is also highly lipophilic which enhances its tissue penetration, intracellular absorption and bioavailability. The high lipophilicity is reflected in the high volume of distribution of approximately 500 L. The molecule has established benefits in the diabetic population as well with its partial PPAR-gamma activity and thus is the choice of ARB in diabetic hypertensives,

As per guideline recommendations, the recommended treatment regime to begin with is an SPC of 2 antihypertensive drugs. There is not much published literature especially in the Indian diabetic hypertensive population for the choice of treatment and early interventions to manage hypertension and retard the progression of kidney disease.

Cilnidipine and Telmisartan, both being effective anti-hypertensive drugs with beneficial effects in diabetic patients, can be the initial choice of combination to begin early with, in diabetic hypertensive Indian patients for effective blood pressure control with an objective of end-organ protection. With this trial, the objective was to understand the beneficial effects on reno-protection when a CCB (with reno-protective properties) is added to an ARB and the effectiveness of a dual combination of anti-hypertensives in achieving BP goals.

This prospective trial is being proposed with an objective to evaluate the efficacy and safety of an SPC of Cilnidipine (10mg) + Telmisartan (40mg) compared to Telmisartan (40mg) and explore the effects of the SPC on renal outcomes in Indian Diabetic hypertensive patients.