Clinical trial NCT01509001: Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus
Official title: Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
metformin
glimepiride
glucose control
vascular reactivity
Adverse Reaction to Other Drugs and Medicines
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Detailed description: Measurements were be made at fasting

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes patients with fasting glucose values \>7.78 mmol/L and/or glycated hemoglobin exceeding 1.0% or more the normal range (4-8.5%) after 2 or more months of a diet therapy

Exclusion Criteria:

* any severe concomitant illness
* nephropathy (serum creatinine \>1.6 mg/dL and microalbuminuria)
* uncontrolled hypertension (BP \>190x120 mmHg)
* stroke
* peripheral vascular disease
* marked dyslipidemia (total cholesterol\>6.5mM/L and triglycerides levels \>2.8mM/L)
* coagulopathy
* proliferative retinopathy and use of hypolipemic and anticoagulant medications or autonomic neuropathy
* assessed by blood pressure response to standing
* beat-to -beat heart rate variation
* Valsalva maneuver and handgrip test.

Primary outcomes:
measure: glucose control
timeFrame: every 2 weeks
Secondary outcomes:
measure: haemodynamic improvement
timeFrame: every 4 months
Other outcomes:
Locations:
city: são Paulo
country: Brazil
facility: Clinical Hospital of São Paulo Medical School
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Maria Elizabeth R Silva, Md,Phd
role: PRINCIPAL_INVESTIGATOR
References: