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

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Metformin; Drug: Glimepiride

Detailed Description

Measurements were be made at fasting

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • são Paulo, SP, Brazil
      • Clinical Hospital of São Paulo Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Metformin; 750 to 2500 mg/day, two times a day during 4 months; Other Names: glifage
Active Comparator: 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	Drug: Glimepiride; 1 to 8 mg/day , two times a dya, during 4 months.; Other Names: Amaryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose control	measurements of glucose , glycated haemoglobin and insulin levels	every 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
haemodynamic improvement	flow indexes of carotid and brachial arteries	every 4 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Maria Elizabeth R Silva, Md,Phd, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 11, 2012
• First Posted (Estimate): January 12, 2012

Study Record Updates

• Last Update Posted (Estimate): January 16, 2012
• Last Update Submitted That Met QC Criteria: January 13, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: type 2 diabetes; glucose control; metformin; glimepiride; vascular reactivity; Adverse Reaction to Other Drugs and Medicines
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Metformin; Glimepiride
• Other Study ID Numbers: SILVAMER; CUNHAMR (Other Identifier: University of Sao Paulo)