Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Metformin; Drug: Glimepiride

• Registration Number: NCT01509001
• Lead Sponsor: University of Sao Paulo

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

Study Timeline

• Study Start: 2011-01
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-12
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
metformin	Metformin	Participants will randomized into Metformin (750 to 2500 mg/day) or Glimepiride (1 to 8 mg/day) therapy. After 4 months, the patients will crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule
glimepiride	Glimepiride	Participants will randomized into Metformin (750 to 2500 mg/day) or Glimepiride (1 to 8 mg/day) therapy. After 4 months, the patients will crossed-over with no washout period to the alternative treatment for an additional 4-month period on similar dosage schedule

Primary Outcome Measures

Name	Time	Method
glucose control	every 2 weeks	measurements of glucose , glycated haemoglobin and insulin levels

Secondary Outcome Measures

Name	Time	Method
haemodynamic improvement	every 4 months	flow indexes of carotid and brachial arteries

Trial Locations

Locations (1)

Clinical Hospital of São Paulo Medical School; 🇧🇷 são Paulo, SP, Brazil