"A prospective, single centre, double-blinded, randomised trial 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 200 Indian Diabetic hypertensive patients. The study drug will be Cilacar T (10/40)"

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

Epidemiology: The prevalence of diabetes and hypertension in India is highacross all geographical settings and socioeconomic groups in middle and oldage, according to a study published in JAMA International. The number of peoplewith 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% andobesity and overweight was significantly associated with the prevalence ofhypertension in diabetics. Another study by Shashank et al. reported theexistence of hypertension to be as high as 59.3% in diabetic patients.

The development of hypertension indiabetic individuals not only complicates treatment strategy and increaseshealthcare costs but also heightens the risk for macrovascular and microvascularcomplications considerably. Although BP lowering is followed by a significantreduction in cardiovascular and microvascular morbidity and mortality, a largeproportion of diabetic patients exhibit poorly controlled hypertension.

In this population, hypertensionincreases risk for kidney disease onset and progression and cardiovascular (CV)morbidity and mortality. Diabetic nephropathy is the most common cause of CKDin those with diabetes and is one of the leading attributable cause forincident end stage renal disease (ESRD). Thereis evidence that blood pressure reduction has been associated with a decreasedrisk of diabetes related complications.

As per guideline recommendations, therecommended treatment regime to begin with is an SPC of 2 antihypertensivedrugs. There is not much publishedliterature especially in the Indian diabetic hypertensive population for thechoice of treatment and early interventions to manage hypertension and retardthe progression of kidney disease.

Cilnidipineis a novel and promising CCB developed forthe management of hypertension, possesses both L and N type calcium channelblocking activity. It is well known among physicians for its uniquesympatholytic action and a major advantage of reno-protection (reduction inproteinuria, podocyte protection, reduction in glomerular pressure), thusrevolutionizing the treatment of hypertension with an added advantage of end organprotection.

Cilnidipine also has shown to improveinsulin sensitivity in patients of essential hypertension possibly due to itsvasodilatory action without stimulating sympathetic nervous activity.

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

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

As per guideline recommendations, therecommended treatment regime to begin with is an SPC of 2 antihypertensivedrugs. There is not much published literature especially in the Indian diabetichypertensive population for the choice of treatment and early interventions tomanage hypertension and retard the progression of kidney disease.

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

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