Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
Aim:
The purpose of this study is to compare the effects of glimepiride(G) and metformin(M) on
vascular reactivity, haemostatic factors and glucose and lipid profile in patients with type
2 diabetes.
Methods:
A prospective study will be performed in 20 uncontrolled patients previously treated with
dietary intervention. Participants will randomized into M (750 to 2500 mg/day) or G (1 to 8
mg/day) therapy. After 4 months, the patients will be crossed-over with no washout period to
the alternative treatment for an additional 4-month period on similar dosage schedule.
- The following variables were assessed before (basal values) and after 4 months of each
treatment period:
1. Hormonal and metabolic determinations: fasting plasma glucose, insulin,
catecholamine, lipid profile and HbA1 levels.
2. Haemostatic factors: t-PA antigen and activity, PAI-1 antigen and activity,
platelet aggregation, fibrinogen and plasminogen levels.
3. Cardiovascular evaluation: flow indexes of carotid and brachial arteries. Also, at
the end of each treatment period, a 12-hour metabolic profile including
measurements of glucose, insulin, glucagon, proinsulin and triglycerides levels at
fasting and every 2 hours (7:00 am to 7:00 pm)will be done