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

NCT ID: NCT01509001

Last Updated: 2012-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-01-31

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

750 to 2500 mg/day, two times a day during 4 months

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

Group Type: ACTIVE_COMPARATOR

Glimepiride

Intervention Type: DRUG

1 to 8 mg/day , two times a dya, during 4 months.

Interventions

Metformin

750 to 2500 mg/day, two times a day during 4 months

Intervention Type: DRUG

Glimepiride

1 to 8 mg/day , two times a dya, during 4 months.

Intervention Type: DRUG

Other Intervention Names

glifage; Amaryl

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Maria Elizabeth Rossi da Silva

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Elizabeth R Silva, Md,Phd

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Clinical Hospital of São Paulo Medical School

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CUNHAMR

Identifier Type: OTHER

Identifier Source: secondary_id

SILVAMER

Identifier Type: -

Identifier Source: org_study_id