MATCHED (MC-1 and ACE Therapeutic Combination for Hypertensive Diabetics)
The purpose of this study is to determine whether MC-1 alone and in combination with an ACE inhibitor is effective in reducing blood pressure and metabolic dysfunctions associated with diabetes
Diabetes Mellitus Type 2
Drug: pyridoxal-5'-phosphate with and without ACE inhibitor
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Evaluation of the Effects of MC-1 Alone and in Combination With an ACE Inhibitor on Ambulatory Blood Pressure and Metabolic Function in Hypertensive Patients With Type 2 Diabetes Mellitus|
- Effects on blood pressure:
- Determine the efficacy of MC-1 and of the combination of MC-1/ACE inhibitor on blood pressure as measured by mean daytime ambulatory systolic blood pressure.
- Effects on metabolic function:
- Determine the efficacy of MC-1 and of the combination of MC-1/ACE inhibitor on metabolic function as measured by insulinemia, fasting serum glucose, glycated hemoglobin, and triglycerides.
- To compare the effects of the different treatment regimens as measured by:
- mean change from baseline in mean daytime ambulatory diastolic BP
- mean change from baseline in mean 24 hour and mean night-time ambulatory systolic BP
- mean changes from baseline in mean 24 hour, mean daytime and mean night-time pulse pressure
- mean changes from baseline in clinic trough sitting systolic BP (SiSBP)
- mean changes from baseline in mean 24 hour, and mean night-time ambulatory diastolic BP
- mean changes from baseline in clinic trough sitting diastolic BP (SiDBP)
- mean change in endothelial function as measured by mean changes in different markers such as ICAM-1, VCAM-1, E-selectin and albuminuria
- mean changes in C-reactive protein (CRP)
- mean changes in homocysteine
- mean changes in creatinine
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||July 2005|
Hypertension is an extremely common co-morbid condition in diabetics, affecting up to 11 million patients, depending on obesity, ethnicity and age. Hypertension substantially increases the risk of both macrovascular and microvascular complications including stroke, coronary artery disease, peripheral vascular disease, retinopathy, nephropathy and possibly neuropathy.
In recent years, adequate data from well-designed randomized clinical trials have demonstrated the effectiveness of aggressive treatment of hypertension in reducing diabetic complications. In the epidemiological UK Prospective Diabetes Study (UKPDS), each 10 mmHg decrease in mean systolic blood pressure was associated with reductions in risk of 12% for any complication related to diabetes, 15% for deaths related to diabetes, 11% for myocardial infarction and 13% for microvascular complications. Currently the consensus guidelines recommend a blood pressure target of <130/80 mmHg in diabetic patients with hypertension, even though they recognize many people will require three or more drugs to reach this goal.
MC-1 is a naturally occurring metabolite of vitamin B6, and thus has very low toxicity. Evidence from pre-clinical studies suggests that MC-1 has beneficial effects on hypertension and metabolic dysfunction. This trial will assess the effects of MC-1 alone and MC-1 in combination with an ACE inhibitor compared to placebo on hypertension and parameters of metabolic function in type 2 diabetic patients.
|Centre Hospitalier Université Laval|
|Sainte-Foy, Quebec, Canada, G1V 4G2|
|Principal Investigator:||Yves Lacourciere, MD, FRCP||Centre Hospitalier de l'Universite Laval|