Skip to main content
. 2017 Mar 6;2017(3):CD009868. doi: 10.1002/14651858.CD009868.pub3

NCT02842359.

Methods Randomised, open‐label, parallel‐assignment trial
Participants Aged ≥ 19 years to < 75 years
No medication history of hyperlipidaemia and hypertension within 3 months following registration, among people with type 2 diabetes diagnosed with hyperlipidaemia and stage I hypertension (systolic blood pressure: ≥ 140 mmHg, ≤ 159 mmHg or diastolic blood pressure: ≥ 90 mmHg, ≤ 99 mmHg), with adequately controlled haemoglobin levels
Diagnosis of diabetes: haemoglobin A1c ≥ 6.5% or; fasting plasma glucose level above 8 hour ≥ 126 mg/dL or plasma glucose ≥ 200 mg/dL ( 11.1 mmol/l) 2 h after a 75 g glucose load or symptoms (such as polyuria, polydipsia, unexplained weight loss) and a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L)
Interventions Irbesartan/atorvastatin fixed‐dose combination: pharmaceutical form: tablet; route of administration: oral; other name: Rovelito
Comparators
Irbesartan SR47436: pharmaceutical form: tablet; route of administration: oral; other name: Aprovel
Atorvastatin: pharmaceutical form: tablet; route of administration: oral; other name: Newvast
Outcomes Primary outcomes: (time frame: 4 weeks‐maximum 5 weeks)
  • Change from baseline in flow mediated dilatation


Secondary outcomes: (Time frame: 4 weeks up to maximum 5 weeks)
  • Rate of change from baseline in nytrotyrosine marker

  • Rate of change from baseline in Intercellular Adhesion Molecule‐1

  • Rate of change from baseline in interleukin‐6

  • Rate of change from baseline in C‐reactive protein

  • Change from baseline in blood pressure (irbesartan/atorvastatin fixed‐dose combination group and irbesartan group)

  • Change from baseline in low density lipoprotein‐C (irbesartan/atorvastatin fixed‐dose combination group and atorvastatin group)

  • Change from baseline in total cholesterol (irbesartan/atorvastatin fixed‐dose combination group and atorvastatin group)

  • Change from baseline in high density lipoprotein‐C (irbesartan/atorvastatin fixed‐dose combination group and atorvastatin group)

  • Change from baseline in triglycerides (irbesartan/atorvastatin fixed‐dose combination group and atorvastatin group)

  • Change from baseline in apolipoprotein‐A1 (irbesartan/atorvastatin fixed‐dose combination group and atorvastatin group)

  • Change from baseline in apolipoprotein‐B (irbesartan/atorvastatin fixed‐dose combination group and atorvastatin group) ‐Percentage of participants with decreased level of blood pressure (irbesartan/atorvastatin fixed‐dose combination group and irbesartan group)]

  • Rate of change from baseline in immunosenescence T cell fractionation

  • Rate of change from baseline in T‐cell induced inflammatory factors

Notes