DETAIL Study: Diabetes Exposed to Telmisartan and Enalapril
Condition: Hypertension; Diabetes Mellitus, Type 2
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the renal consequences of two different approaches to blocking the renin
      angiotensin system in subjects with hypertension and concurrent Type II diabetes mellitus and
      diabetic nephropathy.
    

Detailed description: 
      The aims of this study were to compare the renal consequences of two different approaches to
      blocking the activity of the renin angiotensin system - Angiotensin II antagonism with
      telmisartan and ACE inhibition with enalapril - in patients with hypertension and concurrent
      type II diabetes mellitus and diabetic nephropathy.

      The study was designed to investigate albumin excretion rates in the short term, and in the
      longer term, to assess the outcome with respect to maintenance of renal function (GFR) and
      incidence of clinical endpoints.

      Study Hypothesis:

      Association of Hypertension and Diabetes Essential hypertension accounts for the majority of
      hypertension in people with diabetes, particularly in those with type II diabetes, who
      constitute more than 90% of those with a dual diagnosis of diabetes and hypertension.

      Both diabetes and hypertension each confer increased cardiovascular risk, and patients with
      both conditions have more atherogenic risk factors.

      Albumin Excretion as a Therapeutic Marker Microalbuminuria is an early and reliable predictor
      of diabetic nephropathy in both type I - insulin dependent diabetes mellitus (IDDM) and type
      II - non insulin dependent diabetes mellitus (NIDDM) patients, nephropathy being
      characterised by hypertension and an inevitable decline in renal function.

      Furthermore, diabetic nephropathy is the single most important cause of end stage renal
      failure (ESRF) in the western world and over recent years the incidence of ESRF in patients
      with type II diabetes has dramatically increased.

      In addition to predicting nephropathy, in type II diabetes, microalbuminuria also predicts
      mortality, the major causes of death being related to cardiovascular disease.

      Comparison(s):

      Selection of an ACE Inhibitor as the Comparative Agent Findings in preclinical studies of
      animals with diabetes mellitus suggest that ACE inhibitors reduce glomerular damage by one or
      more mechanisms independent of their antihypertensive effects. Glomerular efferent arteriolar
      tone is increased in diabetic animals and as a result there is an increase in transcapillary
      hydraulic pressure. These alterations may decrease the functional integrity of the glomerular
      capillary wall. In rats with diabetes, the long term administration of an ACE inhibitor
      diminishes the functional and morphologic evidence of glomerular injury and decreases
      glomerular transcapillary pressure. Removal of the tonic constrictor effect of angiotensin II
      on efferent arterioles would be expected to lower glomerular intracapillary pressure while
      preserving renal plasma flow.

      Angiotensin II antagonists appear to be as effective as ACE inhibitors in delaying the
      progression of renal injury in animal models of diabetes.
    

Intervention name(s): telmisartan; enalapril
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan; Enalapril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention